| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | AA | AB | AC | AD | AE | AF | AG | AH | AI | AJ | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | TrialID | Expert search | Other records | Completion date before Aug 2013? | Last_Refreshed_on | Public_title | Scientific_title | Acronym | Primary_sponsor | Date_registration | Export_date | Source_Register | web_address | Recruitment_Status | other_records | Inclusion_agemin | Inclusion_agemax | Inclusion_gender | Date_enrollement | Target_size | Study_type | Study_design | Phase | Countries | Contact_Firstname | Contact_Lastname | Contact_Address | Contact_Email | Contact_Tel | Contact_Affiliation | Intervention | Primary_outcome | Secondary_outcome | Secondary_ID | Source_Support | Secondary_Sponsor | |
2 | EUCTR2004-001317-34-FI | OR "001317" | NCT00168805 | Yes | 19 March 2012 | A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. - RE-MODEL (Thromboembolism prevention after knee surgery) | A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. - RE-MODEL (Thromboembolism prevention after knee surgery) | Boehringer Ingelheim Finland Ky | 17/09/2004 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001317-34 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 01/11/2004 | 2010 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Double dummy<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Hungary;Finland;Czech Republic;Germany;Denmark;Spain;Italy;Sweden | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: equal<br>Concentration number: 110-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Klexane 40 mg<br>Product Name: Klexane<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: enoxaparin<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: equal<br>Concentration number: 40-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br> | Main Objective: To determine the comparative efficacy of two oral regimens of dabigatran etexilate compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery.;Secondary Objective: To determine the comparative safety of two oral regimens of dabigatran etexilate compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery.;Primary end point(s): Composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.<br>Total VTE includes: deep vein thrombosis (proximal and distal) as detected by routine venography performed (within 24 hours) of the last dose of oral study medication; symptomatic DVT, confirmed by venous duplex ultrasound, venography, or by autopsy and pulmonary embolism confirmed by pulmonary ventilation-perfusion scintigraphy and chest X-ray or pulmonary angiography or spiral CT.<br> | 1160.25 | ||||||||||||||
3 | EUCTR2010-024534-38-AT | OR "024534" | Yes | 19 March 2012 | New medication for the prophylaxis of thrombosis in patients with mechanical heart support | Pilot-Trial: Dabigatran as an alternative anticoagulant in patients with left ventricular assist device | Medizinische Universität Wien, Abteilung für Herzchirurgie | 06/06/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024534-38 | Authorised | No | <br>Female: yes<br>Male: yes<br> | 19/07/2011 | 30 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Austria | Abteilung für Herzchirurgie | Waeringer Guertel 18 - 20 | martin.andreas@meduniwien.ac.at | +431404006969 | Medizinische Universität Wien | <br>Trade Name: PRADAXA 110 mg - Hartkapseln<br>Product Name: PRADAXA 110 mg - Hartkapseln<br>Pharmaceutical Form: Tablet<br><br>Trade Name: PRADAXA 75 mg - Hartkapseln<br>Product Name: EU/1/08/442/001-004<br>Pharmaceutical Form: Tablet<br><br>Trade Name: Marcoumar - Tabletten<br>Product Name: Marcoumar - Tabletten<br>Pharmaceutical Form: Tablet<br><br>Trade Name: Fragmin 2500 IE - Fertigspritzen<br>Product Name: Fragmin 2500 IE - Fertigspritzen<br>Pharmaceutical Form: Injection<br><br> | Main Objective: To assess safety of Dabigatran administration in LVAD (HeartWare) patients<br><br>;Secondary Objective: 2) To estimate sample size for a multi-center clinical trial<br>3) To evaluate patient contentment in this patient cohort <br>;Timepoint(s) of evaluation of this end point: every visit during the study;Primary end point(s): - Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications <br>- Number of major and minor bleeding events (TIMI bleeding classification)<br>- Patient contentment (regular assessment with a questionnaire) <br>- Number of patients with necessary treatment changes<br> | Secondary end point(s): - Increase of liver enzymes > 3 times upper limit <br>- Treatment effects on coagulation parameters <br>;Timepoint(s) of evaluation of this end point: every routine blood draw during the study | Version 1.1 | Medical University of Vienna | ||||||||
4 | EUCTR2007-002630-11-NL | OR "002630" | NCT00657150 | 19 March 2012 | A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty. (RE-NOVATE II) - RE-NOVATE II | A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty. (RE-NOVATE II) - RE-NOVATE II | Boehringer Ingelheim Pharma GmbH & CoKG | 01/02/2008 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002630-11 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 07/04/2008 | 1920 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Hungary;Finland;Czech Republic;Germany;Netherlands;Denmark;Belgium;Spain;Italy;Austria;Sweden | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR1048MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>Current Sponsor code: BI1048MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Clexane<br>Product Name: Clexane<br>Product Code: n.a.<br>Pharmaceutical Form: Injection*<br>INN or Proposed INN: enoxaparin<br>Current Sponsor code: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 40-<br>Pharmaceutical form of the placebo: Injection*<br>Route of administration of the placebo: Subcutaneous use<br><br> | Main Objective: The primary objective is to demonstrate the safety and efficacy of once daily 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily in preventing venous thromboembolism in patients following total hip replacement surgery. ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint of this study is the composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period. | 1160.64;n.a. | |||||||||||||||
5 | EUCTR2004-001988-21-FI | OR "001988" | NCT00168818 | 19 March 2012 | A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery. - RE-NOVATE (Extended thromboembolism prevention after hip surgery) | A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery. - RE-NOVATE (Extended thromboembolism prevention after hip surgery) | Boehringer Ingelheim Finland Ky | 17/09/2004 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001988-21 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 01/11/2004 | 3330 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Double dummy<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Hungary;Finland;Czech Republic;Germany;Denmark;Spain;Italy;Sweden | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: dabigatran etexilate <br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Klexane 40 mg<br>Product Name: Klexane<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Enoxaparin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 40-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br> | Main Objective: To determine the comparative efficacy of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.;Secondary Objective: To determine the comparative safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.;Primary end point(s): Composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.<br>Total VTE includes deep vein thrombosis [DVT] (proximal and distal) as detected by routine venography performed within 24 hours of the last dose of oral study medication; symptomatic DVT, confirmed by venous duplex ultrasound, venography or by autopsy; and pulmonary embolism confirmed by pulmonary ventilation-perfusion (V-Q) scintigraphy and chest X-ray or pulmonary angiography or spiral CT.<br> | 1160.48 | |||||||||||||||
6 | EUCTR2005-002536-94-FI | OR "002536" | NCT00329238 | 24 April 2012 | A phase III, randomised, multicenter, double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for the secondary prevention of venous thromboembolism. RE-MEDY - RE-MEDY | A phase III, randomised, multicenter, double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for the secondary prevention of venous thromboembolism. RE-MEDY - RE-MEDY | Boehringer Ingelheim Finland Ky | 07/02/2006 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002536-94 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 20/03/2006 | 2000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Double dummy<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Hungary;Portugal;Germany;Bulgaria;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Greece | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Current Sponsor code: BIBR 1048 MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Warfarin tablets BP 1mg<br>Product Name: Warfarin tablets BP 1mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Parenteral use (Noncurrent)<br><br>Trade Name: Marevan 3 mg<br>Product Name: Warfarin tablets BP 3 mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Parenteral use (Noncurrent)<br><br>Trade Name: Marevan 5 mg<br>Product Name: Warfarin tablets BP 5 mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Parenteral use (Noncurrent)<br><br> | Main Objective: To determine the comparative efficacy of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to six months for confirmed acute symptomatic venous thromboembolism.;Secondary Objective: To determine the comparative safety of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment of venous thrombolembolism.;Primary end point(s): Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE during the treatment period. <br>VTE is defined as the composite incidence of DVT and PE<br> | 1160.47 | |||||||||||||||
7 | EUCTR2007-007536-25-NL | OR "007536" | NCT00818753 | 19 March 2012 | Randomized, Open-label study of Dabigatran Etexilate, a Novel, oral, Direct Thrombin-inhibitor in clinical development, in Elective Percutaneous Coronary Intervention. (D-Fine) - D-Fine | Randomized, Open-label study of Dabigatran Etexilate, a Novel, oral, Direct Thrombin-inhibitor in clinical development, in Elective Percutaneous Coronary Intervention. (D-Fine) - D-Fine | Boehringer Ingelheim b.v. | 02/06/2008 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007536-25 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 26/08/2008 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Netherlands | <br>Product Name: Pradaxa<br>Product Code: BI 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BI1048MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br>Product Name: Pradaxa<br>Product Code: BI1048MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BI1048MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br><br>Trade Name: Heparine LEO<br>Product Name: Heparine LEO<br>Product Code: n.a.<br>Pharmaceutical Form: Injection*<br>INN or Proposed INN: unfractionated heparin<br>CAS Number: n.a.<br>Current Sponsor code: n.a.<br>Other descriptive name: n.a.<br>Concentration unit: U unit(s)<br>Concentration type: range<br>Concentration number: 50-70 U/kg-<br><br> | Main Objective: To assess whether two doses of dabigatran etexilate (110 mg b.i.d., 150 mg b.i.d.) as compared to UFH, both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective PCI.;Secondary Objective: - To assess the coagulation profile of two different doses of dabigatran etexilate in addition to a standard dual antiplatelet regimen in the setting of elective PCI.<br>- To investigate the safety of dabigatran etexilate plus dual antiplatelet therapy, particularly with respect to bleeding complications.<br>;Primary end point(s): Anticoagulant effect will be determined based on the number of patients who need rescue anticoagulant and/or have clinical signs of catheter related thrombosis during the PCI procedure (until removal of the guiding catheter and the patient has left the catheterization suite). | 1160.73;n.a. | ||||||||||||||||
8 | EUCTR2007-002631-86-BG | OR "002631" | NCT00680186 | 19 March 2012 | A phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment for at least 5 days with a parenteral anticoagulant approved for this indication. RE-COVER II - RE-COVER II | A phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment for at least 5 days with a parenteral anticoagulant approved for this indication. RE-COVER II - RE-COVER II | Boehringer Ingelheim Austia Gm.b.H | 22/04/2008 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002631-86 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 23/10/2008 | 2550 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Double-dummy<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Hungary;Czech Republic;United Kingdom;Netherlands;Denmark;France;Bulgaria;Spain;Italy;Sweden | <br>Product Name: dabigatran eteilate<br>Product Code: BIBR 1048<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9<br>Current Sponsor code: BI1048MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Warfarin tablets BP 1 mg<br>Product Name: Warfarin tablets BP 1 mg<br>Product Code: n.a.<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Current Sponsor code: n.a.<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Warfarin tablets BP 3 mg<br>Product Name: Warfarin tablets BP 3 mg<br>Product Code: n.a.<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>CAS Number: n.a.<br>Current Sponsor code: n.a.<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Warfarin tablets BP 5 mg<br>Product Name: Warfarin tablets BP 5 mg<br>Product Code: n.a.<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>CAS Number: n.a.<br>Current Sponsor code: n.a.<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: The primary objective is to investigate the efficacy of dabigatran etexilate 150 mg bid administered orally compared to warfarin PRN to maintain an INR of 2.0-3.0 for a 6 month treatment period according to the study endpoints in patients with acute symptomatic Venous Thromboembolic Event (VTE is defined as the composite incidence of Deep Vein Thrombosis of the leg and pulmonary embolism.);Secondary Objective: The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.;Primary end point(s): A composite of recurrent symptomatic VTE and deaths related to VTE within 6 months. VTE is defined as the composite incidence of DVT of the leg (including the inferior caval vein) and PE.<br><br>All recurrent VTE require objective verification by definitive diagnostic evaluation:<br>• Any suspected DVT must be confirmed by venous compression ultrasonography (CUS) or venography.<br>• Any suspected PE must be confirmed by one of the following: ventilation-perfusion<br>(V-Q) lung scan, pulmonary angiography, or spiral (helical) CT.<br><br>In case of death, autopsy is an additional way to confirm VTE. | 1160.46;n.a. | |||||||||||||||
9 | EUCTR2010-022985-29-ES | OR "022985" | NCT01478282 | 19 March 2012 | EVALUACIÓN DEL POTENCIAL DE LOS CONCENTRADOS DE FACTORES DE LA COAGULACIÓN ACTIVADOS EN LA REVERSIÓN DE LA ACCIÓN ANTICOAGULANTE DE LOS NUEVOS AGENTES ANTITROMBÓTICOS ORALES: ESTUDIOS EX VIVO EN SANGRE DE VOLUNTARIOS SANOS. | EVALUACIÓN DEL POTENCIAL DE LOS CONCENTRADOS DE FACTORES DE LA COAGULACIÓN ACTIVADOS EN LA REVERSIÓN DE LA ACCIÓN ANTICOAGULANTE DE LOS NUEVOS AGENTES ANTITROMBÓTICOS ORALES: ESTUDIOS EX VIVO EN SANGRE DE VOLUNTARIOS SANOS. | Fundació Privada Clinic per la Recerca Biomèdica | 28/02/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022985-29 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 30/05/2011 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: <br>Open: <br>Single blind: <br>Double blind: <br>Parallel group: <br>Cross over: <br>Other: <br>If controlled, specify comparator, Other Medicinial Product: <br>Placebo: <br>Other: <br> | Spain | <br>Trade Name: PRADAXA 75 mg cápsulas duras<br>Pharmaceutical Form: Capsule*<br>INN or Proposed INN: DABIGATRAN ETEXILATO MESILATO<br>Other descriptive name: DABIGATRAN ETEXILATO MESILATO<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br><br>Trade Name: XARELTO 10 mg comprimidos recubiertos con película<br>Pharmaceutical Form: Capsule*<br>INN or Proposed INN: RIVAROXABAN<br>Other descriptive name: RIVAROXABAN<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br><br> | Main Objective: El objetivo final es mejorar la seguridad y eficiencia de la práctica clínica con la nueva generación de anticoagulantes orales (Dabigatran y Rivaroxaban).;Secondary Objective: 1. Determinar el efecto de los nuevos anticoagulantes orales (Dabigatran y Rivaroxaban) en la hemostasia con una atención específica en las posibles interferencias con la interacción plaquetaria y los mecanismos de la coagulación bajo condiciones de flujo.<br>2. Evaluar comparativamente la actividad de los concentrados conteniendo factores de la coagulación de eficacia conocida (concentrados de protrombina y FVIIar) para revertir las alteraciones de los parámetros de la hemostasia inducidas por los nuevos anticoagulantes.<br>Estos últimos estudios se llevarán a cabo ex vivo en muestras de sangre obtenidas de voluntarios sanos sometidos a tratamiento anticoagulante oral a dosis de reconocida eficacia y seguridad empleadas en ensayos clínicos.;Primary end point(s): -Valoración morfométrica de la interacción plaquetaria y la formación de fibrina sobre una superficie trombogénica.<br>-Determinación de los niveles del fragmento F1+2 de la protrombina antes y después de la perfusión.<br>-Capacidad de generación de trombina (GT).<br>-Pruebas de coagulación: tiempo de protrombina y tiempo de ecarina.<br><br>Se valorará: 1) Los decrementos en los parámetros analíticos estudiados tras el tratamiento con dabigatran o rivaroxaban; y 2) Los incrementos/mejoras en los parámetros analíticos tras la adición de concentrados de factores.<br> Variables secundarias del estudio se relacionan con aspectos de seguridad como son molestias o efectos secundarios que los participantes en el estudio puedan reportar. <br>Experiencia previa del equipo investigador permite anticipar que un n=10 por grupo permite un poder estadístico suficiente para establecer comparaciones entre datos apareados pre y post tratamiento para las variables primarias. Nuestro estudio no tiene potencia estadística suficiente para analizar las variables secundarias que simplemente se referirán como observaciones. | REVANT | ||||||||||||||||
10 | EUCTR2010-022846-26-FR | OR "022846" | Yes | 19 March 2012 | Réversion de l'effet anticoagulant des nouveaux antithrombotiques anti Xa et anti IIa par des médicaments hémostatiques spécifiques ou non spécifiques : étude ex vivo chez le volontaire sain. - ReversNewAnticoag | Réversion de l'effet anticoagulant des nouveaux antithrombotiques anti Xa et anti IIa par des médicaments hémostatiques spécifiques ou non spécifiques : étude ex vivo chez le volontaire sain. - ReversNewAnticoag | University Hospital of Grenoble | 16/09/2010 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022846-26 | Authorised | No | <br>Female: no<br>Male: yes<br> | 08/11/2010 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | France | <br>Trade Name: XARELTO®<br>Pharmaceutical Form: Coated tablet<br>INN or Proposed INN: RIVAROXABAN<br>CAS Number: 366789-02-8<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 20-<br><br>Trade Name: PRADAXA®<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>CAS Number: 211915-06-9<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br> | Primary end point(s): - critère de jugement principal : Test de génération de thrombine<br>- critère de jugement secondaires :<br>Temps de thrombine, Temps de céphaline activée pour l'effet de réversion sur le dabigatran<br>Temps de Quick plasmatique, Mesure de l’activité antiXa pour l'effet de réversion sur le Rivaroxaban;Main Objective: L’objectif principal de cette étude est de tester ex vivo l’effet des CCP, rFVIIa et FEIBA® sur la réversion d’un anti thrombine direct, le dabigatran, et l’effet d’un inhibiteur spécifique FXa-GLAless sur la réversion d’un anti Xa direct, le rivaroxaban ;Secondary Objective: - L’objectif secondaire de cette étude est de tester ex vivo l’effet des CCP, rFVIIa et FEIBA® sur la réversion d’un anti thrombine direct, le dabigatran sur les tests d’hémostase classiques<br>- L’objectif secondaire de cette étude est de tester ex vivo l’effet d’un inhibiteur spécifique FXa-GLAless sur la réversion d’un anti Xa direct, le rivaroxaban sur les tests d’hémostase classiques | 1015 | ||||||||||||||||
11 | EUCTR2005-001999-12-GB | OR "001999" | NCT00291330 | 26 June 2012 | A phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. RE-COVER - RE-COVER | A phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. RE-COVER - RE-COVER | Boehringer Ingelheim Ltd. | 19/12/2005 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001999-12 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 14/03/2006 | 2550 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Double dummy<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Portugal;Hungary;Finland;Germany;Czech Republic;United Kingdom;Denmark;Spain;Italy;Greece;Sweden | <br>Product Name: dabigatrane etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Current Sponsor code: BIBR 1048 MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: Warfarin tablets BP 1mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: Warfarin tablets BP 3 mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: Warfarin tablets BP 5 mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: To determine the comparative efficacy of dabigatran etexilate (150 mg bid), compared to warfarin (INR of 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism (VTE).;Secondary Objective: To determine the comparative safety of dabigatran etexilate (150 mg bid), compared to warfarin (INR of 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism (VTE).;Primary end point(s): Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE within 6 months. (VTE is defined as the composite incidence of DVT and PE.)<br> | 1160.53 | |||||||||||||||
12 | EUCTR2005-003894-26-SE | OR "003894" | NCT00262600 | 18 April 2012 | Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY) - RE-LY | Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY) - RE-LY | Boehringer Ingelheim AB | 28/10/2005 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003894-26 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 23/12/2005 | 15000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Comparison Warfarin Dabigatran open. Dabigatran dose double blind.<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: <br>Other: <br> | Portugal;Hungary;Finland;United Kingdom;Germany;Czech Republic;Denmark;Spain;Italy;Greece;Sweden | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Current Sponsor code: BIBR 1048 MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br><br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Current Sponsor code: BIBR 1048 MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br>Trade Name: Warfarin tablets BP<br>1 mg<br>Product Name: Warfarin tablets BP 1mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br><br>Trade Name: Warfarin tablets BP<br>3 mg<br>Product Name: Warfarin tablets BP 3mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg/kg milligram(s)/kilogram<br>Concentration type: equal<br>Concentration number: 3-<br><br>Trade Name: Warfarin tablets BP<br>5 mg<br>Product Name: Warfarin tablets BP 5 mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: warfarin<br>Concentration unit: mg/kg milligram(s)/kilogram<br>Concentration type: equal<br>Concentration number: 5-<br><br> | Main Objective: To demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.;Secondary Objective: ;Primary end point(s): Incidence of all stroke (including hemorrhagic) or systemic embolism. | 1160.26 | |||||||||||||||
13 | EUCTR2011-000504-18-DE | OR "000504" | 26 June 2012 | DABI-ADP-2: IMPACT OF DABIGATRAN AND PHENPROCOUMON ON CLOPIDOGREL MEDIATED ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-2 | DABI-ADP-2: IMPACT OF DABIGATRAN AND PHENPROCOUMON ON CLOPIDOGREL MEDIATED ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-2 | Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen | 21/02/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000504-18 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 10/05/2011 | 70 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Germany | <br>Trade Name: Pradaxa<br>Product Name: Pradaxa<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>CAS Number: 211915-06-9<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration number: 75-<br><br>Trade Name: Marcumar<br>Product Name: Marcumar<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PHENPROCOUMON<br>CAS Number: 435-97-2<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration number: 3-<br><br> | Main Objective: The primary hypothesis to be tested is whether dabigatran is superior to phenprocoumon in the reduction of clopidogrel mediated ADP induced platelet aggregation.<br>The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on 14 day after initiation of therapy.;Secondary Objective: 1. Platelet function tests ( ADPtest HS (MEA) 6.4µmol/l ADP in the presence of 9.4 nmol/l prostaglandin E1, TRAP-6 (32µmol/l), Collagen (3.2µg/ml collagen (COLtest))<br>2. Coagulation parameters (aPTT, INR, Thrombin coagulation Time)<br>3. Dabigatran Plasmalevels <br>;Primary end point(s): The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on 14 day after initiation of therapy. | A01711 | ||||||||||||||||
14 | EUCTR2008-006866-27-Outside-EU/EEA | OR "006866" | 3 April 2012 | Safety and tolerability of dabigatran etexilate in adolescents | Open-label safety and tolerability study of dabigatran etexilate given for 3 days at the end of standard anticoagulant therapy in children aged 12 years to less than 18 years | Boehringer Ingelheim (Canada) Ltd./Ltée | 15/03/2012 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006866-27 | Not Available | No | <br>Female: yes<br>Male: yes<br> | 8 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Canada | QRPE PSC CT Information Disclosure | Binger Strasse 173 | clintriage.rdg@boehringer-ingelheim.com | +18002430127 | Boehringer Ingelheim Pharma GmbH & Co. KG | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR 1048 MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br><br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR 1048 MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br><br> | Main Objective: To investigate tolerability and safety of dabigatran etexilate capsules in adolescents;Secondary Objective: none;Primary end point(s): 1) Incidence of all bleeding events,<br>2) Incidence of all adverse events,<br>3) Pharmacodynamic parameters: central and local measurement of TT,<br>4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE.<br>;Timepoint(s) of evaluation of this end point: Endpoints 1) & 2) measured during screening, treatment period and 30 day followup.<br>Endpoints 3) & 4) measured during screening (baseline) and treatment period. | Secondary end point(s): 1) Changes in laboratory and clinical parameters such as liver enzymes, ECG, and physical <br>examination, <br>2) Occurrences of clinical outcomes including recurrent thrombosis, post thrombotic <br>syndrome (PTS), pulmonary emboli (PEs), and total and venous thrombolic event (VTE) <br>related mortality objectively assessed for example by ultrasound, venography or <br>computed chromatography (CT) scan (based on the thrombus location). <br>3) pharmacodynamic parameters: central and local measurement of aPTT and ECT;Timepoint(s) of evaluation of this end point: Endpoints 1) and 2) measured during screening, treatment period and 30 day followup. <br>Endpoint 3) measured during screening (baseline) and treatment period. | 1160.88 | Boehringer Ingelheim (Canada) Ltd./Ltée | ||||||||||
15 | EUCTR2012-001814-41-AT | OR "001814" | 3 July 2012 | Antithrombotic triple therapy and its effects on coagulation markers in venous and shed blood | A prospective, randomized, controlled, analyst-blinded, parallel group study to investigate the effect of antithrombotic triple therapy with ticagrelor and acetylsalicylic acid in combination with dabigatran or rivaroxaban or phenprocoumon on markers of coagulation activation in venous and shed blood in healthy male subjects - Antithrombotic triple therapy | Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie | 30/04/2012 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001814-41 | Authorised | No | <br>Female: no<br>Male: yes<br> | 20/06/2012 | 60 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: analyst-blinded<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Austria | Secretary | Währinger Gürtel 18-20 | klin-pharmakologie@meduniwien.ac.at | 00431404002981 | Medical University of Vienna, Department of Clinical Pharmacology | <br>Trade Name: Brilique 90mg<br>Product Name: Brilique 90mg<br>Pharmaceutical Form: Tablet<br>CAS Number: 274693-27-5<br>Other descriptive name: TICAGRELOR<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 90-<br><br>Trade Name: Thrombo ASS 100mg<br>Product Name: Thrombo ASS<br>Pharmaceutical Form: Tablet<br>CAS Number: 50-78-2<br>Other descriptive name: ACETYLSALICYLIC ACID<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: Xarelto 20mg<br>Product Name: Xarelto 20mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: RIVAROXABAN<br>CAS Number: 366789-02-8<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 20-<br><br>Trade Name: Pradaxa 150mg<br>Product Name: Pradaxa 150mg<br>Pharmaceutical Form: Capsule, hard<br>Other descriptive name: DABIGATRAN ETEXILATE MESILATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br>Trade Name: Marcoumar 3mg<br>Product Name: Marcoumar 3mg<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PHENPROCOUMON<br>CAS Number: 435-97-2<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br><br> | Primary end point(s): ß-TG, F1+2 and TAT in shed blood;Timepoint(s) of evaluation of this end point: at baseline and 3 hours after drug intake;Main Objective: • To evaluate the effect of ticagrelor + ASA in combination with dabigatran, rivaroxaban or phenprocoumon at steady state on markers of coagulation activation: prothrombin fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT), ß-thromboglobulin (ß-TG), D-Dimer, thromboxane B2 (TxB2), CD40 ligand (CD40L), p-Selectin in venous and shed blood.<br>• To evaluate the effect of ticagrelor + ASA in combination with dabigatran, rivaroxaban or phenprocoumon at steady state on systemic coagulation in resting condition by assessment of the endogenous thrombin potential (ETP), on markers of coagulation (inhibition of factor Xa activity (anti FXa), activated partial thromboplastin time (aPTT), prothrombin time (PT) and Hemoclot®) and shed blood volume. <br>;Secondary Objective: • To evaluate the effect of phenprocoumon at a therapeutic INR range of 2 – 3 and of a single dose administration of dabigatran, rivaroxaban or ticagrelor on markers of coagulation activation: F1+2, TAT, ß-TG, D-Dimer, TxB2, CD40L, p-Selectin in venous and shed blood.<br>• To evaluate the effect of phenprocoumon at a therapeutic INR range of 2 – 3 and of a single dose administration of dabigatran, rivaroxaban or ticagrelor on systemic coagulation in resting condition by assessment of ETP, on markers of coagulation (anti FXa activity, aPTT, PT & Hemoclot®) and shed blood volume.<br> | Secondary end point(s): • D-Dimer, TxB2, CD40L and p-Selectin in shed blood<br>• ß-TG, F1+2, TAT, D-Dimer, TxB2, CD40L, p-Selectin, ETP, aPTT, PT, inhibition of factor Xa and Hemoclot® in venous blood<br>;Timepoint(s) of evaluation of this end point: shed blood parameter: at baseline and 3 hours after drug intake<br><br>venous blood parameter: at baseline, 1, 2 and 3 hours after drug intake | ATTT-1.0 | Medical University of Vienna; Department of Clinical Pharmacology | |||||||||
16 | EUCTR2011-003081-32-NL | OR "003081" | 24 April 2012 | Dabigatran, an anticoagulant drug in patients with impaired renal function | DABIRENAL STUDY A study to investigate the pharmacokinetics and effects of Dabigatran in patients with stable severe chronic kidney disease - lumc-30706-IV | Leiden University Medical Center | 24/02/2012 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003081-32 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 18/04/2012 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: no comparator<br>Number of treatment arms in the trial: 1<br> | Netherlands | Judith Kooiman | Albinusdreef 2, postzone C4-70 | j.kooiman@lumc.nl | 0031715264839 | Leiden University Medical Center | <br>Trade Name: Dabigatran Etexilate (pradaxa)<br>Product Name: Dabigatran Etexilate (pradaxa)<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>CAS Number: 211915-06-9<br>Current Sponsor code: lumc-30706-IV<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br><br> | Main Objective: To analyze the pharmacokinetics and dynamics of Dabigatran 75 mg twice daily in patients with severe CKD (eGFR 15 - 30 ml/min) until steady state of the drug is established. ;Secondary Objective: - Effects of Dabigatran on D-dimer levels in patients with chronic kidney disease<br>- HAS-BLED en Chads-Vasc scores;Primary end point(s): - Overall safety and tolerability profile (AEs, routine labs, vital signs)<br>- Pharmacodynamics: onset, maximal effect, overall (AUC per 24 hrs) effect for frequently measured coagulation parameters and <br>change from baseline when applicable (fibrinogen, AT) Hemoclot test<br>- Pharmacokinetics: Cmax, Tmax, AUC, T½ , CL/F, Vz/F, renal excretion (tbd: plasma protein binding, proportion of total dabigatran <br>excreted as glucuronides) <br>;Timepoint(s) of evaluation of this end point: Lab sampling will be drawn at the following points in time:<br>• Predose<br>• .5<br>• 1<br>• 2<br>• 3<br>• 4<br>• 6<br>• 8<br>• 12<br>• 23.5<br>• 27.5<br>• 47.5<br>• 51.5<br>• 71.5<br>• 75.5<br>• 95.5<br>• 99.5<br>• 119.5<br>• 123, 5<br>• 167<br>• 168.5<br>• 169<br>• 170<br>• 171<br>• 172<br>• 174<br>• 176<br>• 180<br>• 192<br>• 216<br>• 240<br>This scheme requires a patient’s admission for two days of thirteen hours (predose -13 hours and 167-180 after the first intake). From day two until day six, two samples will be drawn each day, one prior and one after oral intake of dabigatran. For all blood drawings (accept those between 0-13 and 167-180 hours), the possibility of a visiting home nurse will be offered to all study patients. <br> | Secondary end point(s): - D-dimer levels <br>- HAS-BLED and Chads-Vasc scores;Timepoint(s) of evaluation of this end point: Lab sampling will be drawn at the following points in time: <br>• Predose <br>• .5 <br>• 1 <br>• 2 <br>• 3 <br>• 4 <br>• 6 <br>• 8 <br>• 12 <br>• 23.5 <br>• 27.5 <br>• 47.5 <br>• 51.5 <br>• 71.5 <br>• 75.5 <br>• 95.5 <br>• 99.5 <br>• 119.5 <br>• 123, 5 <br>• 167 <br>• 168.5 <br>• 169 <br>• 170 <br>• 171 <br>• 172 <br>• 174 <br>• 176 <br>• 180 <br>• 192 <br>• 216 <br>• 240 <br>This scheme requires a patient’s admission for two days of thirteen hours (predose -13 hours and 167-180 after the first intake). From day two until day six, two samples will be drawn each day, one prior and one after oral intake of dabigatran. For all blood drawings (accept those between 0-13 and 167-180 hours), the possibility of a visiting home nurse will be offered to all study patients. <br> | lumc-30706-IV | Leiden University Medical Center | ||||||||||
17 | EUCTR2011-003556-39-NL | OR "003556" | 26 June 2012 | A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA | A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA | Martini Hospital Groningen | 24/05/2012 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003556-39 | Authorised | No | <br>Female: yes<br>Male: yes<br> | 05/06/2012 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Netherlands | Lucia van der Veen | Van Swietenplein 1 | l.vd.veen@mzh.nl | 00310505246783 | Martini Hospital Groningn | <br>Trade Name: Pradaxa<br>Product Name: dabigatran etexilate<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>CAS Number: 211915-06-9<br>Current Sponsor code: pradaxa<br>Other descriptive name: no<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 150-220<br><br>Trade Name: Xarelto<br>Product Name: rivaroxaban<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: RIVAROXABAN<br>CAS Number: 366789-02-8<br>Current Sponsor code: Xarelto<br>Other descriptive name: no<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br><br>Trade Name: Fraxiparin<br>Product Name: nadroparin<br>Pharmaceutical Form: Injection<br>INN or Proposed INN: NADROPARIN<br>CAS Number: no<br>Current Sponsor code: fraxiparin<br>Other descriptive name: no<br>Concentration unit: anti-Xa IU anti-Xa activity International Unit(s)<br>Concentration type: equal<br>Concentration number: 2850-<br><br> | Main Objective: The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneously administered nadroparin by observing the incidence of major bleeding and clinically relevant non-major bleeding in patients after knee arthroplasty surgery.;Secondary Objective: The secondary objectives of this study are effectivity of the agents, time till bleeding event, compliance, hospital stay, re-hospitalisation, outpatient clinic visits and interventions following complications. Additionally, coagulation monitoring, knee flexion range of motion, Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship between health statuses and surgery parameters will be evaluated.;Primary end point(s): The primary endpoint of this study is the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneously administered nadroparin by observing the incidence of major bleeding and clinically relevant non major bleeding in patients after knee arthroplasty surgery.;Timepoint(s) of evaluation of this end point: After closure of the clinical trial a blinded committee will score bleeding events independently by defining the observed bleeding by the orthopaedic surgeon and the patient information. | Secondary end point(s): The secondary endpoints of this study are effectivity of the agents (occurrence of PE or DVT), time till bleeding event, compliance, hospital stay, re-hospitalisation, outpatient clinic visits and interventions following complications. ;Timepoint(s) of evaluation of this end point: After closure of the clinical trial a blinded committee will score bleeding events independently by defining the observed bleeding by the orthopaedic surgeon and the patient information. | DARINA;NCT01430456 | Martini Hospital Groningen | ||||||||||
18 | EUCTR2012-002263-96-NL | OR "002263" | 7 August 2012 | dabigatran and rivaroxaban: prediction of anticoagulant effect | dabigatran and rivaroxaban: prediction of anticoagulant effect - Thrombin predict | MUMC | 29/06/2012 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002263-96 | Authorised | No | <br>Female: yes<br>Male: yes<br> | 11/07/2012 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Netherlands | department of biochemistry | oxfordlaan 70 | b.delaat@thrombin.com | 31(0)433885896 | MUMC | <br>Trade Name: xarelto<br>rivaroxaban<br>Pharmaceutical Form: Film-coated tablet<br><br>Trade Name: Pradaxa<br>dabigatran<br>Pharmaceutical Form: Capsule, hard<br><br> | Main Objective: The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation. In addition, we want to investigate whether there is a correlation between the in-vivo effect and ex- vivo effect in a patient by spiking blood of patients before treatment with rivaroxaban or the active metabolite of dabigatran. ;Secondary Objective: not applicable;Primary end point(s): The main study parameter is thrombin generation. In addition, liver enzymes and renal function will be measured, as well as several additional tests for coagulation status. The end-point will be the variation in anticoagulant effect in different patients and the correlation between in vivo and in vitro (anticoagulant) effects of rivaroxaban or dabigatran. ;Timepoint(s) of evaluation of this end point: 0= before start of study medication<br>1= 1 week after start of study medication<br>2= two weeks after start of study medication | Secondary end point(s): -;Timepoint(s) of evaluation of this end point: timepoint 0 (before start of medication) <br>timepoint 1 (after 7 days) <br>timepoint 2 (after 14 days) | 39486 | MUMC | ||||||||||
19 | EUCTR2005-001998-10-GB | OR "001998" | 24 April 2012 | A phase III, randomized, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran etexilate administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous for 12 – 15 days in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery - RE-MOBILIZE | A phase III, randomized, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran etexilate administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous for 12 – 15 days in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery - RE-MOBILIZE | Boehringer Ingelheim Ltd. | 04/07/2005 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001998-10 | Authorised | No | <br>Female: yes<br>Male: yes<br> | 01/08/2005 | 2610 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | United Kingdom | <br>Product Name: dabigatran etexilate <br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: dabigatran etexilate <br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9 <br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Lovenox<br>Product Name: Lovenox<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: enoxaparin<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 30-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Subcutaneous use<br><br> | Main Objective: The goal of this study is to determine the comparative efficacy and safety of two different dose regimens (75mg day 1 followed by 150 mg day 2 to completion, and 110 mg day 1 followed by 220 mg day 2 to completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. ;Secondary Objective: Secondary efficacy endpoints will include any of the following that occur during the treatment period:<br>1. Composite of major VTE (defined as proximal DVT and PE) and VTE related mortality (endpoint recommended in the EMEA advice for non-inferiority therapeutic confirmatory trials (1))<br>2. Proximal Deep-Vein Thrombosis (DVT)<br>3. Total DVT <br>4. Symptomatic DVT<br>5. Pulmonary Embolism (PE)<br>6. Death<br>An additional secondary efficacy endpoint will be the composite of total VTE and all-cause mortality during the follow-up period. <br>;Primary end point(s): The primary efficacy endpoint of this study is the composite of total venous thromboembolic events (VTE) and all-cause mortality. <br>Total VTE includes: <br>- deep vein thrombosis (proximal and distal) as detected by routine bilateral venography performed within 24 hours after the last oral study medication<br>- symptomatic DVT occurring during the treatment period, confirmed by venography, venous duplex ultrasound or by autopsy<br>- pulmonary embolism confirmed by perfusion (Q) scintigraphy and chest X-ray or pulmonary angiography or spiral CT <br> | 1160.24 | ||||||||||||||||
22 | EUCTR2011-000503-40-DE | OR "000503" | 16 October 2012 | DABI-ADP-1: IMPACT OF DABIGATRAN AND PHENPROCOUMON ON ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-1 | DABI-ADP-1: IMPACT OF DABIGATRAN AND PHENPROCOUMON ON ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-1 | Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen | 18/02/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000503-40 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 12/04/2011 | 70 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br> | Germany | <br>Trade Name: Pradaxa<br>Product Name: Pradaxa<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>CAS Number: 211915-06-9<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration number: 75-<br><br>Trade Name: Marcumar<br>Product Name: Marcumar<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PHENPROCOUMON<br>CAS Number: 435-97-2<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration number: 3-<br><br> | Main Objective: The primary hypothesis to be tested is whether dabigatran is superior to phenprocoumon in the reduction of ADP induced platelet aggregation.<br>The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on day 14 after initiation of therapy.;Secondary Objective: 1. Platelet function tests ( ADPtest HS (MEA) 6.4µmol/l ADP in the presence of 9.4 nmol/l prostaglandin E1, TRAP-6 (32µmol/l), Collagen (3.2µg/ml collagen (COLtest))<br>2. Coagulation parameters (aPTT, INR, Thrombin coagulation Time)<br>3. Dabigatran Plasmalevels <br>;Primary end point(s): The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on day 14 after initiation of therapy. | GE IDE No. A01611 | ||||||||||||||||
27 | EUCTR2011-002084-20-AT | OR "002084" | 15 July 2013 | Influence of anticoagulants on microparticle formation | A prospective, randomized, controlled open-label trial to investigate the effects of 10mg rivaroxaban or 110mg dabigatran on microparticle formation in critically ill patients compared to age-& sex-matched subjects - MP & anticoagulants | Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie | 01/06/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002084-20 | Not Recruiting | No | <br>Female: yes<br>Male: yes<br> | 28/07/2011 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Austria | Secretary of the Department | Waehringer Guertel 18-20 | michael.wolzt@meduniwien.ac.at | 431404002981 | Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie | <br>Trade Name: Xarelto 10 mg<br><br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: RIVAROXABAN<br>CAS Number: 366789-02-8<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br><br>Trade Name: Pradaxa 110mg<br>Pharmaceutical Form: Capsule, hard<br>Other descriptive name: DABIGATRAN ETEXILATE MESILATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br><br> | Main Objective: To evaluate the effect of Xarelto/ Pradaxa on microparticle formation in critically ill compared to age- & sex-matched subjects.;Secondary Objective: To evaluate the effects of Xarelto/ Pradaxa on fibrin formation in an ex-vivo perfusion chamber model.<br>To evaluate the effects of Xarelto/ Pradaxa on systemic fibrin formation by assessment of the endogenous thrombin potential, thrombin coagulation time, levels of D-Dimers, prothrombin fragement 1+2, soluble sP-selectin and aPTT;Primary end point(s): Plasma Microparticle concentrations;Timepoint(s) of evaluation of this end point: baseline, 3, 6 and 10hrs after IMP adminstration | Secondary end point(s): 1. Thrombus size (D-Dimer content of degraded ex-vivo thrombus) <br>2. Endogenous thrombin potential (ETP) <br>3. Human fibrin fragment F1+2, thrombin coagulation time (TCT), levels of D-Dimers, soluble sP-selectin and of activated partial thromboplastin time (aPTT). <br>;Timepoint(s) of evaluation of this end point: baseline, 1, 3,6 and 10hrs after IMP administration | Version_1.0_MP_and_anticoagulants | Department of Clinical Pharmacology, Medical University of Viennna | ||||||||||
30 | EUCTR2007-004301-99-SE | OR "004301" | 31 July 2012 | RandomisEd Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel: Multi-centre, prospective, placebo controlled, group dose escalation trial (RE-DEEM STUDY) - RE-DEEM | RandomisEd Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel: Multi-centre, prospective, placebo controlled, group dose escalation trial (RE-DEEM STUDY) - RE-DEEM | Boehringer Ingelheim AB | 06/11/2007 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004301-99 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 06/02/2008 | 2220 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: Group dose escalation<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br> | Hungary;Germany;France;Bulgaria;Ireland;Italy;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Poland | <br>Product Name: dabigatran etexilate 50 mg<br>Product Code: BI1048MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatarn etexilate<br>Current Sponsor code: BI1048MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: dabigatarn etexilate 75 mg<br>Product Code: BI1048MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>Current Sponsor code: BI1048MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: dabigatarn etexilate 110 mg<br>Product Code: BI1048MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatarn etexilate<br>Current Sponsor code: BI1048MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: dabigatran etexilate 150 mg<br>Product Code: BI1048MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>Current Sponsor code: BI1048MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Secondary Objective: Exploratory evaluation of total dabigatran trough plasma concentration versus the bleeding risk on the background of concomitant ASA and clopidogrel and the relationship of trough plasma levels to biomarkers.<br><br>The effects of dabigatran etexilate treatment on markers of myocardial dysfunction and damage, renal dysfunction, inflammation, platelet activation and other markers of coagulation activity, will be explored.<br>;Primary end point(s): The composite of major and clinically relevant minor bleeding events during six months of treatment.;Main Objective: The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event at high risk for new ischaemic cardiovascular events.<br><br> | 1160.67;n.a. | ||||||||||||||||
31 | EUCTR2010-018723-26-FI | OR "018723" | 13 May 2013 | An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery | An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery | Boehringer Ingelheim Finland Ky | 31/05/2010 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018723-26 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 15/07/2010 | 120 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: <br>Placebo: <br>Other: <br> | Czech Republic;Finland;Austria;Sweden | <br>Trade Name: Pradaxa<br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR 1048 MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br><br> | Main Objective: To assess the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot® and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery.<br><br>;Secondary Objective: To evaluate the correlation between total Dabigatran plasma concentration and coagulation parameters using the Hemoclot® Direct Thrombin Inhibitor Assay, aPTT and ECT in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery in steady state condition.<br>;Primary end point(s): Endpoints based on biomarker(s). Pharmacodynamic endpoints: <br>- Clotting time using Hemoclot Thrombin Inhibitor Assay calibrated with dabigatran standards.<br>- activated partial thromboplastin time (aPTT)<br>- Ecarin time (ECT) | 1160.86 | ||||||||||||||||
36 | EUCTR2008-005248-17-SE | OR "005248" | 21 August 2012 | RELY-ABLE long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes - RELY-ABLE | RELY-ABLE long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes - RELY-ABLE | Boehringer Ingelheim AB | 25/09/2008 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005248-17 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 20/11/2008 | 6000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: <br>Open: <br>Single blind: <br>Double blind: <br>Parallel group: <br>Cross over: <br>Other: <br>If controlled, specify comparator, Other Medicinial Product: <br>Placebo: <br>Other: <br> | Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Greece;Poland | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR 1048 MS<br>Other descriptive name: Pradaxa<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br><br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR1048MS<br>Other descriptive name: Pradaxa<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br> | Main Objective: This trial has two main objectives:<br><br>1. To evaluate the long-term safety of two doses of dabigatran. <br><br>2. To evaluate the efficacy of patient customized audit and feedback compared to general information on best practice to reduce cardiovascular outcomes.<br><br>;Secondary Objective: ;Primary end point(s): 1. Since the objective of this trial is safety, there are no primary efficacy endpoints related to the evaluation of dabigatran. Safety will primarily be determined by the occurrence of major bleeding. <br>2. The primary endpoint for knowledge translation component is the composite endpoint of vascular death, stroke, myocardial infarction (MI), non-CNS systemic embolism, major bleeding and hospitalization for heart failure.<br> | 1160.71;n.a. | ||||||||||||||||
43 | ACTRN12613001304729 | OR "ACTRN12613001304729" OR "12613001304729" | 26 November 2013 | A multicentre, observational, prospective study of the current practice in major centres in Australia and New Zealand for achieving haemostasis in consecutive patients who present with significant haemorrhage, thromboembolism or urgent surgery whilst on new or established oral anticoagulants | A multicentre, observational, prospective study of the current practice in major centres in Australia and New Zealand for achieving haemostasis in consecutive patients who present with significant haemorrhage, thromboembolism or urgent surgery whilst on new or established oral anticoagulants | Other Collaborative groups ARES Collaborative | 22/11/2013 | 7/31/2014 5:09:42 AM | ANZCTR | http://www.anzctr.org.au/ACTRN12613001304729.aspx | Not recruiting | No | 0 No limit | 0 No limit | Both males and females | 20/05/2012 | 2000 | Observational | Not Applicable | Australia,Outside;New Zealand | Mrs Wendy Angelatos | The Perth Blood Institute Hollywood Medical Centre Suite 37/85 Monash Avenue Nedlands WA 6009, New Zealand | info@aptin.org | +61 892002236 | This is an observational study to document in major centres in Australia and New Zealand the current practice for achieving haemostasis in patients who present with significant haemorrhage, thromboembolism or urgent surgery whilst on new (dabigatran, rivaroxaban, apixaban or endoxaban) or established (warfarin) oral anticoagulants. The duration of the study is 36 months. | To observe the current practice for achieving haemostasis in 2000 patients who present with significant haemorrhage or urgent surgery whilst on new (dabigatran, rivaroxaban, apixaban or endoxaban) or established (warfarin) oral anticoagulants. Data will be collected by reviewing patients’ medical records. | In patients whilst on oral anticoagulants who present with embolism, determine the circumstances and level of anticoagulation at the time of presentation. Data will be collected by reviewing patients’ medical records. | Nil | Australasian Society of Thrombosis and Haemostasis (ASTH) | ASTH | |||||||
47 | EUCTR2010-022685-27-SE | OR "022685" | 14 April 2014 | Dabigatran etexilate in patients with mechanical heart valves | A Randomised, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt - RE-ALIGN | Boehringer Ingelheim AB | 07/07/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022685-27 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 02/09/2011 | 405 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | France;United States;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden | Lisa Hörnquist | Box 47608 | lisa.hornquist@boehringer-ingelheim.com | 4687212168 | Boehringer Ingelheim AB | <br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR 1048 MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br><br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: n.a.<br>Current Sponsor code: BIBR 1048 MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br><br>Trade Name: Warfarin 1 mg Tablets BP<br>Product Name: Warfarin 1mg Tablets BP<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Warfarin Sodium BP<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br><br>Trade Name: Warfarin 3 mg Tablets BP<br>Product Name: Warfarin 3 mg Tablets BP<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Warfarin Sodium BP<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br><br>Trade Name: Warfarin 5mg Tablets BP<br>Product Name: Warfarin 5mg Tablets BP<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Warfarin Sodium BP<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br><br> | Main Objective: To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve. ;Secondary Objective: Clinical safety and efficacy outcome variables, mortality and morbidity endpoints, will all be evaluated in an exploratory manner;Primary end point(s): The comparison of observed total dabigatran plasma concentrations values at trough compared to values estimated by dose modelling;Timepoint(s) of evaluation of this end point: Day 4-7 following start of dabigatran etexilate; four and twelve weeks | Secondary end point(s): clinical efficacy and safety outcome variables will be studies in an exploratory manner;Timepoint(s) of evaluation of this end point: full trial duration (12 weeks) | 1160.113 | ||||||||||
55 | EUCTR2014-000388-41-NL | OR "000388" | 12 May 2014 | Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve significant levels and thrombin inhibiting activity in the eye? | Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid? - Dabigatran & Ocular Accessibility | The Rotterdam Eye Hospital | 13/03/2014 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000388-41 | Authorised | No | <br>Female: yes<br>Male: yes<br> | 05/05/2014 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Netherlands | Rotterdam Ophthalmic Institute | PO Box 70030 | r.wubbels@oogziekenhuis.nl | 31104023430 | The Rotterdam Eye Hospital | <br>Trade Name: Pradaxa(r)<br>Pharmaceutical Form: Capsule, hard<br><br> | Main Objective: Quantifying dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid after oral administration of dabigatran etexilate in patiens with a retinal detachment.;Secondary Objective: Not applicable;Primary end point(s): Levels of dabigatran in vitreous, subretinal fluid and plasma. <br>Antithrombin activity in vitreous and subretinal fluid and plasma.<br>;Timepoint(s) of evaluation of this end point: During surgery | Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | OZR-2013-27 | Stichting Wetenschappelijk Onderzoek Oogziekenhuis - Prof. Dr. Flieringa (SWOO) | ||||||||||
57 | JPRN-UMIN000007579 | OR "000007579" | 3 June 2014 | Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF) | Committee on Proper Use of Anticoagulant Therapies | 27/03/2012 | 7/31/2014 5:09:42 AM | JPRN | http://www.umin.ac.jp/ctr/index.htm | Recruiting | No | 20years-old | Not applicable | Male and Female | 2012/04/01 | 500 | Interventional | Parallel Randomized | Japan | Administration of a proton pump inhibitor<br>Administration of an H2 receptor antagonists<br>Administration of a gastric mucosal protective drug | - Severity of dyspepsia symptoms during the observational phase of the study <br>- Improvement rate of dyspepsia symptoms | - Percentage of patients with improvement in the severity of dyspepsia symptoms by two points or more on the GOS scale <br>- Percentage of patients with resolution of dyspepsia symptoms (i.e., percentage of patients with improvement in the severity to a GOS scale score of 1) <br>- Percentage of patients with improvement in dyspepsia symptoms (i.e., percentage of patients who still have their main dyspepsia symptoms, but with improvement in the severity to a GOS scale score of 1 or 2) <br>- Post-treatment severity of dyspepsia symptoms compared with baseline (i.e., change in the GOS scale score from baseline) <br>- Safety | The Waksman Foundation | ||||||||||||||
58 | JPRN-UMIN000006344 | OR "000006344" | 3 June 2014 | Evaluation of abdominal symptoms and gastrointestinal mucosal injuries in patients receiving oral anticoagulant dabigatran | Kobe University Hospital | 14/09/2011 | 7/31/2014 5:09:42 AM | JPRN | http://www.umin.ac.jp/ctr/index.htm | Not Recruiting | No | 20years-old | Not applicable | Male and Female | 2011/10/01 | 50 | Interventional | Parallel Randomized | Japan | Dabigatran 300mg/day + Rabeprazole 10mg/day for 4 weeks<br>Dabigatran 300mg/day + Famotidine 20mg/day for 4 weeks<br>Dabigatran 300mg/day + Rebamipide 300mg/day for 4 weeks | The incidence of upper endoscopic findings(redness, petechia, erosion, and ulcer) after administration of dabigatran for 4 weeks | a. Evaluation of abdominal symptoms <br>b. The effect of various antiulcer agents in patients with dabigatran-induced gastrointestinal mucosal injuries | None | ||||||||||||||
66 | ChiCTR-TRC-13004062 | OR "13004062" | 29 June 2014 | Dabigatran versus warfarin in patients of atrial fibrillation or atrial flutter with Radiofrequency Catheter Ablation | Dabigatran versus warfarin in patients of atrial fibrillation or atrial flutter with Radiofrequency Catheter Ablation | Qilu Hospital, Shandong Province | 2013-12-30 | 7/31/2014 5:09:42 AM | ChiCTR | http://www.chictr.org/en/proj/show.aspx?proj=6359 | Recruiting | No | 18 | 75 | Both | 2014-01-01 | dabigatran:40;warfarin:40; | Interventional | Randomized parallel control | China | Jingquan Zhong | No. 107 West Culture Road, Lixia District, Jinan City, Shandong Province, China | gilman_zhong@hotmail.com | +86 13791123056 | dabigatran:dabigatran 150mg BID p.o.;warfarin:maintain INR2~3; | coagulation indicator;Echocardiography;blood routine examination; | autonomous | ||||||||||
68 | EUCTR2007-002586-12-DE | OR "002586" | 5 November 2012 | Twice-daily oral direct thrombin inhibitor dabigatran in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. - Re-Sonate | Twice-daily oral direct thrombin inhibitor dabigatran in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. - Re-Sonate | Boehringer Ingelheim Pharma GmbH & Co. KG | 30/08/2007 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002586-12 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 1800 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br> | Estonia;Czech Republic;Belgium;Poland;Lithuania;Austria;Latvia;Netherlands;Germany;Italy;Sweden | <br>Product Name: Dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: dabigatran etexilate<br>CAS Number: 211915-06-9<br>Current Sponsor code: BIBR 1048 MS<br>Other descriptive name: n.a.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with a vitamin K antagonist (VKA).;Secondary Objective: ;Primary end point(s): The primary efficacy outcome is symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE | 1160.63 | |||||||||||||||||
71 | EUCTR2013-004813-41-DE | OR "004813" | 2 June 2014 | Reversal of dabigatran anticoagulant effect with idarucizumab | A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. | Boehringer Ingelheim Pharma GmbH & Co. KG | 03/02/2014 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004813-41 | Authorised | Yes | <br>Female: yes<br>Male: yes<br> | 26/05/2014 | 250 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: <br>Placebo: <br>Other: <br>Number of treatment arms in the trial: 1<br> | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Lebanon;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Japan;Sweden | QRPE PSC CT information Disclosure | Binger Str. 173 | clintriage.rdg@boehringer-ingelheim.com | +1 8002430127 | Boehringer Ingelheim GmbH & Co. KG | <br>Product Name: idarucizumab<br>Product Code: BI 655075<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: idarucizumab<br>Current Sponsor code: BI 655075<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 50-<br><br> | Main Objective: Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab;Secondary Objective: Evaluate safety and the pharmacokinetcs of the idarucizumab-dabigatran complex.;Primary end point(s): 1: Reversal of anticoagulant effect of dabigatran<br>;Timepoint(s) of evaluation of this end point: 1: up to 4 hours<br> | Secondary end point(s): 1: Minimum unbound sum (free) dabigatran <br> <br>2: Reversal of dTT or ECT after the first infusion and before the start of the second <br> <br>3: Reversal of aPTT <br> <br>4: Reversal of TT <br> <br>5: Duration of reversal <br> <br>6: Occurrence of major bleeding post-surgery (for Group B only) <br> <br>7: Time to cessation of bleeding (for Group A only) <br>;Timepoint(s) of evaluation of this end point: 1: up to 4 hours <br> <br>2: up to 15 minutes <br> <br>3: up to 4 hours <br> <br>4: up to 4 hours <br> <br>5: up to 24 hours <br> <br>6: up to 24 hours <br> <br>7: up to 24 hours <br> | 1321.3 | Boehringer Ingelheim Pharma GmbH & Co. KG | |||||||||
74 | JPRN-UMIN000006907 | OR "000006907" OR "UMIN000006907" | 3 June 2014 | Anticoagulation therapy around catheter ablation for atrial fibrillation -Dabigatran vs. Warfarin- | DAWN-AF-Trial Society | 19/12/2011 | 7/31/2014 5:09:42 AM | JPRN | http://www.umin.ac.jp/ctr/index.htm | Recruiting | No | 20years-old | 75years-old | Male and Female | 2011/06/01 | 100 | Interventional | Parallel Randomized | Japan | Dabigatran group<br>150 mg administered twice daily (2 capsules (75 mg), twice daily)<br>The dosage should be reduced to 110 mg twice daily, as required.<br>Warfarin group<br>Administer once daily (adjust dosage aiming at a PT-INR [prothrombin time-international ratio] of 2.0 - 3.0). However, for patients aged >= 70 yrs, adjust dosage aiming at a PT-INR of 1.6 - 2.6. Blood samples should initially be collected once weekly until the INR stabilizes and then once monthly. However, many patients enrolled in this study are already taking warfarin. In these patients, blood samples can be collected once monthly only. | Total hospitalization period for the perioperative period of atrial fibrillation ablation | The Waksman Foundation of Japan, Inc. | |||||||||||||||
79 | JPRN-UMIN000010494 | OR "UMIN000010494" OR "000010494" | 3 June 2014 | Multi-effects of novel oral anticoagurants in nonvalvular atrial fibrillation study | Tokushima University hospital | 15/04/2013 | 7/31/2014 5:09:42 AM | JPRN | http://www.umin.ac.jp/ctr/index.htm | Recruiting | No | 30years-old | 90years-old | Male and Female | 2013/04/15 | 40 | Interventional | Parallel Randomized | Japan | administration of dabigatran <br>administration of rivaroxaban | the antiarteriosclerotic effcts | NA | |||||||||||||||
86 | JPRN-UMIN000009553 | OR "UMIN000009553" OR "000009553" | 3 June 2014 | Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study- | Division of Cardiology, Yokohama City University Medical Center | 14/12/2012 | 7/31/2014 5:09:42 AM | JPRN | http://www.umin.ac.jp/ctr/index.htm | Recruiting | No | Not applicable | Not applicable | Male and Female | 2013/07/04 | 150 | Interventional | Parallel Randomized | Japan | After baseline assessment of blood examination, patients are assigned to receive rivaroxaban 15mg once daily for 6 months according to a computer-generated randomization sequence at the central registration center. Patients with cleatinine crealance 30-49 mL/min receive rivaroxaban 10mg once daily. <br>After baseline assessment of blood examination, patients are assigned to receive dabigatran 150mg twice daily for 6 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily. | comparison of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) berween 2 treatment groups during 6 months follow-up period | (1)time course of above inflammatory markers in each treatment group during 6 months follow-up period <br>(2)frequency of 6-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism) <br>(3)frequency of 6-month major bleeding (defined as ISTH criteria) | Bayer Yakuhin, Ltd. | ||||||||||||||
89 | ChiCTR-TRC-13003739 | OR "13003739" | 29 June 2014 | dabigatran versus warfarin in patients with atrial fibrillation or atrial flutter 1. dabigatran versus warfarin for thrombus in left atrial/left atrial appendage in patients with nonvalvular atrial fibrillation or atrial flutter;2.dabigatran versus warfarin in patients with bioprosthesis heart valve and atrial fibrillation/atrial flutter | dabigatran versus warfarin in patients with atrial fibrillation or atrial flutter 1. dabigatran versus warfarin for thrombus in left atrial/left atrial appendage in patients with nonvalvular atrial fibrillation or atrial flutter;2.dabigatran versus warfarin in patients with bioprosthesis heart valve and atrial fibrillation/atrial flutter | Qilu Hospital, Shandong Province | 2013-10-29 | 7/31/2014 5:09:42 AM | ChiCTR | http://www.chictr.org/en/proj/show.aspx?proj=5864 | Recruiting | No | 18 | 85 | Both | 2013-11-01 | dabigatran:40;warfarin:40; | Interventional | Randomized parallel control | China | Jingquan Zhong | No. 107 West Culture Road, Lixia District, Jinan City, Shandong Province, China | gilman_zhong@hotmail.com | +86 13791123056 | dabigatran:dabigatran 150mg BID p.o.;warfarin:maintain INR2~3; | coagulation indicator;Echocardiography;blood routine examination; | autonomous | ||||||||||
96 | JPRN-UMIN000013129 | OR "000013129" OR "UMIN000013129" | 29 June 2014 | A prospective,multi-center,parallel-group comparison study to evaluate safety and efficacy of dabigatran during the perioperative period in patients with non-valvular atrial fibrillation who undergo the catheter ablation compared to walfarin | Research group of anticoagulation therapy for NVAF ablation | 14/02/2014 | 7/31/2014 5:09:42 AM | JPRN | http://www.umin.ac.jp/ctr/index.htm | Recruiting | No | 20years-old | 85years-old | Male and Female | 2014/03/01 | 1000 | Interventional | Parallel Randomized | Japan | Administration of dabigatran <br>Administration of walfarin | -Incidence of embolism during perioperative period<br>-Existence or non-existence of atrial thrombus just before the ablation, detected with transesophageal echocardiography or intra-cardiac Echocardiography | -Incidence of major bleeding and embolism during the perioperative period<br>-Incidence of major bleeding during the perioperative period<br>-Incidence of all bleeding during the perioperative period<br>-Incidence of life threatening bleeding during the perioperative period<br>-Incidence of bleeding or embolism during the perioperative period and within 6 months after operation<br>-Number of days of hospitalization<br>-Incidence of ischemic stroke (fatal/non-fatal),systemic embolism, pulmonary embolism,acute myocardial infarction,TIA or vascular death (including hemorrhagic death),all cause mortality and their composite endpoint<br>-NCB(net clinical benefit)measured with the composite endpoint consisting of stroke,systemic embolism,pulmonary embolism,acute myocardial infarction,all cause mortality and major hemorrhage <br>-All adverse event | Nippon Boehringer Ingelheim Co ., Ltd | ||||||||||||||
110 | EUCTR2011-002285-21-CZ | OR "002285" | 30 June 2014 | Follow on study from RE-ALIGN | Evaluation of the long term safety of the use of dabigatran etexilate in patients with a bileaflet mechanical heart valve - RE-ALIGN-EX | Boehringer Ingelheim RCV GmbH & Co KG | 06/09/2011 | 7/31/2014 5:09:42 AM | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002285-21 | Not Recruiting | Yes | <br>Female: yes<br>Male: yes<br> | 20/12/2011 | 405 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | France;United States;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden | QRPE PSC CT Information Disclosure | Binger Strasse 173 | clintriage.rdg@boehringer-ingelheim.com | +18002430127 | Boehringer Ingelheim Pharma GmbH & Co KG | <br>Trade Name: Pradaxa 110 mg hard capsules<br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 110-<br><br>Trade Name: Pradaxa 150 mg hard capsules<br>Product Name: dabigatran etexilate<br>Product Code: BIBR 1048 MS<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: DABIGATRAN ETEXILATE<br>Current Sponsor code: BIBR 1048 MS<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150 -<br><br>Trade Name: Warfarin 1 mg Tablets BP<br>Product Name: Warfarin 1mg Tablets BP<br>Pharmaceutical Form: Tablet<br>Other descriptive name: WARFARIN SODIUM<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1-<br><br>Trade Name: Warfarin 3 mg Tablets BP<br>Product Name: Warfarin 3mg Tablets BP<br>Pharmaceutical Form: Tablet<br>Other descriptive name: WARFARIN SODIUM<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br><br>Trade Name: Warfarin 5 mg Tablets BP<br>Product Name: Warfarin 5mg Tablets BP<br>Pharmaceutical Form: Tablet<br>Other descriptive name: WARFARIN SODIUM<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br><br> | Main Objective: The primary objective of this trial is to obtain long term safety data regarding the use of dabigatran etexilate in patients having received a mechanical bileaflet heart valve.;Secondary Objective: no formal secondary objectives;Primary end point(s): 1: There are no primary or secondary efficacy or safety variables for this study<br>;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only | Secondary end point(s): There are no primary or secondary efficacy or safety variables for this study<br>;Timepoint(s) of evaluation of this end point: clinical safety and efficacy endpoints will be studied in an exploratory manner only | 1160.138 | Boehringer Ingelheim RCV GmbH & Co KG | |||||||||
111 | DRKS00003157 | OR "DRKS00003157" OR OR "00003157" | 21 July 2014 | Effect of daBIGatran and rivaROXaban on Platelets | Effect of daBIGatran and rivaROXaban on Platelets - BIG-ROX-P | Universitätsklinikum Freiburg Innere Medizin 3 | 13/07/2011 | 7/31/2014 5:09:42 AM | German Clinical Trials Register | http://www.drks.de/DRKS00003157 | Not Recruiting | No | 18 Years | no maximum age | Both, male and female | 01/09/2011 | 40 | observational | Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Basic research/physiological study; | Germany | Christoph | Olivier | Hugstetter Str. 55 | Christoph.Olivier@Uniklinik-Freiburg.de | 004976127034010 | Universitätsklinikum Freiburg Innere Medizin 3 | Intervention 1: Patients with first detected atrial fibrillation usually have an indication for OAC. After the physicians´ decision for a long-term treatment with dabigatran or rivaroxaban venous blood will be collected to assess platelet function. A second venous blood collection and platelet function assessment takes place after medication with dabigatran or rivaroxaban, respectively. | change (?) of platelet aggregation assessed by light transmittance aggregometry (LTA) before and after medication. | change (?) of platelet function assessed by Multiplate, VerifyNow and platelet biomarkers before and after medication. | 182/11 | Deutsche Forschungsgemeinschaft;Universitätsklinikum Freiburg | ||||||
117 | IRCT2013082513828N2 | OR "IRCT2013082513828N2" | 21 July 2014 | Comparison of Dabigatran and Enoxaparin in prophylaxy of Thromboembolic events | Comparison of Dabigatran and Enoxaparin in prophylaxy of Thromboembolic events in patient with total knee replacement surgery in Shariati hospital in 1392 - | ?Soicial Security Insurance Office/ Shariati Hospital | 2013-10-08 | 7/31/2014 5:09:42 AM | IRCT | http://www.irct.ir/searchresult.php?id=13828&number=2 | Not Recruiting | No | 18 | 70 | Both male and female | 2013-08-12 | 90 | interventional | Randomization: randomized. Blinding: Double blind. Placebo: not used. Assignment: Parallel. Purpose: Prevention. Other design features: . | Iran, Islamic Republic Of | Dr.Mirdamadi | Heart Departement,Shariati Hospital,Isfahan | drsamirdamadi@yahoo.com/drsamirdamadi@pmd.iaun.ac.ir | 00983112238028 | Assistant Professor of Medical School ,Islamic Azad University,Najafabad Branch | Intervention 1: Dabigatran group: Dabigatran 150 mg stat and 225 mg per day up to 15 days will be prescribed . . Intervention 2: Enoxaparin group:subcutaneous enoxaparin(40 mg)12 hours before surgery and then 40 mg every day up to 15 days will be carrird out<br>. | Deep Vein Thrombophelebitis of Legs. Timepoint: 15 days after surgery. Method of measurement: Sonodoppler of Legs' Veins | Bleeding. Timepoint: Every day up to 15 days and then up 3 months. Method of measurement: Physical Exam | 556783 | Islamic Azad University,Najafabad branch,Isfahan Shariati Hospital | |||||||
119 | NTR2272 | OR "NTR2272" | 21 July 2014 | Prothrombin complex concentrate (Cofact ®) as a potential antidote for novel anticoagulants Dabigatran and Rivaroxaban. | Ability of prothrombin complex concentrate (Cofact ®) to reverse the anticoagulant effect of novel antithrombotic agents. - | Academic Medical Center (AMC), Amsterdam | 06/04/2010 | 7/31/2014 5:09:42 AM | Netherlands Trial Register | http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2272 | Recruiting | No | <br> | 1/4/2010 | 12 | intervention | Randomised: Yes; Masking: Double; Control: Placebo; Group: Crossover; Type: Single arm | The Netherlands | Elise | Eerenberg | Meibergdreef 9, Room F4.139 | E.S.Eerenberg@amc.uva.nl | +31 (0)20 5667516 | Subjects will be divided into two groups. Subjects in group 1 will take Dabigatran 2dd 150 mg on day -2, -1 and 0. Subjects in group 2 will take Rivaroxaban 2dd 20 mg on day -2, -1 and 0. After the fifth dose (on day 0) subjects will be randomized to receive Cofact ® (50 U/kg) or a similar volume of Saline as a single bolus dose i.v. over 15 minutes. After a 10 day wash-out period the procedure is repeated but the alternative treatment (Saline of Co-fact) is administered. | The primary outcome is activation and inhibition of coagulation, as reflected by coagulation tests. | MEC 09/206 | Sanquin Blood Supply | ||||||||||
122 | NTR3312 | OR "NTR3312" | 21 July 2014 | Clinical trial of dabigatran on airway inflammation and coagulation in severe asthma. | A Randomised controlled Trial of Dabigatran Etexilate on airway inflammation and coagulation in severe COrticosteroid dependent asthma. - ARTDECO | Academic Medical Center (AMC), Department of Respiratory Medicine | 28/02/2012 | 7/31/2014 5:09:42 AM | Netherlands Trial Register | http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3312 | Not Recruiting | No | <br> | 15/3/2012 | 36 | intervention | Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized | The Netherlands | C.J. | Majoor | Academic Medical Centre Dept. of Respiratory Medicine (F5-144) Meibergdreef 9 | c.j.majoor@amc.uva.nl | +31 (0)20 5664356 | Patients will be randomized to receive either 220mg of dabigatran etexilate or placebo control for 12 weeks. | Primary end point will be: The change in sputum eosinophilia between baseline and after 12 weeks use of dabigatran etexilate. | Secondary endpoints will be: <br> <br>1. Changes in markers of hemostasis and inflammation in blood, induced sputum and exhaled breath; <br> <br>2. Changes in spirometry and asthma control questionaire (ACQ). | 3.2.11.021 / 2011-005406-30; | Netherlands Asthma Foundation, Academic Medical Center (AMC), Department of Respiratory Medicine | |||||||||
124 | NTR4192 | OR "NTR4192" | 21 July 2014 | Pharmacokinetics and –dynamics of Dabigatran Etexilate and Rivaroxaban in patients requiring PArenteral Nutrition (the PDER PAN study) | Pharmacokinetics and –dynamics of Dabigatran Etexilate and Rivaroxaban in patients requiring PArenteral Nutrition (the PDER PAN study) - the PDER PAN study | Academic Medical Center (AMC), Amsterdam | 01/10/2013 | 7/31/2014 5:09:42 AM | Netherlands Trial Register | http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4192 | Recruiting | No | <br> | 1/10/2013 | 6 | intervention | Randomised: Yes; Masking: Single; Control: Not applicable; Group: Crossover; Type: 2 or more arms, randomized | The Netherlands | S. | Middeldorp | Academic Medical Center (AMC), Department of Vascular Medicine, F4-276, P.O. Box 22660, Meibergdreef 9 | alife@amc.uva.nl | +31 (0)20 5665976 | In a cross-over design, patients will be treated with either rivaroxaban 20 mg once daily for five days or dabigatran etexilate 150 mg twice daily for five days. Between the two treatment periods, a wash out period of at least 4 days will be applied. After each 5-day period of NOAC use, patients will be admitted for a full pharmacokinetic and –dynamic profile will be obtained with 10 blood samples. | The primary outcome is the assessment of PK and PD parameters of the two drugs and the comparison to published values. | The secondary outcome is the comparison between rivaroxaban PK parameters and dabigatran PK parameters (AUC, Cmax and Tmax). | ABR | Academic Medical Center (AMC) | |||||||||
125 | IRCT2012122311855N1 | OR "IRCT2012122311855N1" | 21 July 2014 | ?Dabigatran versus warfarin in atrial fibrillation patients post catheter ablation | A randomized comparison between dabigatran and warfarin on coagulation activity and inflammatory markers in patients with atrial fibrillation - | Tehran University of Medical Science | 2013-01-18 | 7/31/2014 5:09:42 AM | IRCT | http://www.irct.ir/searchresult.php?id=11855&number=1 | Not Recruiting | No | 18 | 150 | Both male and female | 2011-09-01 | 100 | interventional | Randomization: randomized. Blinding: Not blinded. Placebo: not used. Assignment: Parallel. Purpose: Prevention. Other design features: . | Iran, Islamic Republic Of | Sahideh Amini | Pharmacy School, TUMS | sh_amini@razi.tums.ac.ir | 00982166954709 | Tehran University of Medical Sciences | Intervention 1: dabigatran (D) 110 mg twice daily<br><br>(intervention group) . Intervention 2: warfarin (W) adjusted to an international normalized ratio (INR) of 2.0 to 3.0<br>(control group). | CRP. Timepoint: baseline, first month, third month. Method of measurement: serum samples;D-Dimer. Timepoint: baseline, first month, third month. Method of measurement: serum samples;prothrombin fragment F1+2. Timepoint: baseline, first month, third month. Method of measurement: serum samples | bleeding. Timepoint: baseline, first month, third month. Method of measurement: CBC test | Tehran University of Medical Sciences |