Dabigatran etexilate
- Generic Name
- Dabigatran etexilate
- Brand Names
- Pradaxa
- Drug Type
- Small Molecule
- Chemical Formula
- C34H41N7O5
- CAS Number
- 211915-06-9
- Unique Ingredient Identifier
- 2E18WX195X
- Background
Dabigatran etexilate is an oral prodrug that is hydrolyzed to the competitive and reversible direct thrombin inhibitor dabigatran. Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients in whom anticoagulation therapy is indicated. In contrast to warfarin, because its anticoagulant effects are predictable, lab monit...
- Indication
Dabigatran etexilate is available in both oral pellet and capsule form. Dabigatran etexilate pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients between three months and 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. They are also indicated in the same age group to re...
- Associated Conditions
- Deep Vein Thrombosis, Deep vein thrombosis recurrent, Pulmonary Embolism, Recurrent Pulmonary Embolism (Disorder), Recurrent Venous Thromboembolism, Stroke, Systemic Embolism, Venous Thromboembolism
- Associated Therapies
- -
A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)
- First Posted Date
- 2011-06-23
- Last Posted Date
- 2015-10-02
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 42
- Registration Number
- NCT01379300
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
- Conditions
- Interventions
- First Posted Date
- 2011-03-01
- Last Posted Date
- 2014-06-06
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 36
- Registration Number
- NCT01306162
- Locations
- 🇩🇪
1160.112.1 Boehringer Ingelheim Investigational Site, Ulm, Germany
Bioequivalence of Two Different Capsule Types of Dabigatran
- First Posted Date
- 2011-02-07
- Last Posted Date
- 2014-05-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 180
- Registration Number
- NCT01290757
- Locations
- 🇩🇪
1160.117.1 Boehringer Ingelheim Investigational Site, Mannheim, Germany
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
- Conditions
- Interventions
- First Posted Date
- 2010-11-16
- Last Posted Date
- 2014-04-07
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 7
- Registration Number
- NCT01241539
- Locations
- 🇩🇪
1160.121.1 Boehringer Ingelheim Investigational Site, Berlin, Germany
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
- Conditions
- Interventions
- First Posted Date
- 2010-08-19
- Last Posted Date
- 2018-09-25
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 142
- Registration Number
- NCT01184989
- Locations
- 🇫🇮
1160.86.35801 Boehringer Ingelheim Investigational Site, Jyväskylä, Finland
🇨🇦1160.86.01001 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada
🇨🇦1160.86.01002 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
- First Posted Date
- 2010-06-03
- Last Posted Date
- 2014-03-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 174
- Registration Number
- NCT01136408
- Locations
- 🇯🇵
1160.49.014 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan
🇯🇵1160.49.027 Boehringer Ingelheim Investigational Site, Iizuka,Fukuoka, Japan
🇯🇵1160.49.013 Boehringer Ingelheim Investigational Site, Kyoto, Kyoto, Japan
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
- First Posted Date
- 2010-03-10
- Last Posted Date
- 2016-12-28
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 18
- Registration Number
- NCT01083732
- Locations
- 🇹🇭
Boehringer Ingelheim Investigational Site, Khon Kaen, Thailand
Safety and Tolerability of Dabigatran Etexilate in Adolescents
- First Posted Date
- 2009-02-16
- Last Posted Date
- 2014-06-09
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 9
- Registration Number
- NCT00844415
- Locations
- 🇨🇦
1160.88.00002 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada
🇨🇦1160.88.00001 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
- First Posted Date
- 2008-05-20
- Last Posted Date
- 2014-05-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 2589
- Registration Number
- NCT00680186
- Locations
- 🇨🇦
1160.46.02021 Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada
🇨🇦1160.46.02004 Boehringer Ingelheim Investigational Site, Saint John, New Brunswick, Canada
🇨🇦1160.46.02019 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada
Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
- Conditions
- Interventions
- First Posted Date
- 2008-04-14
- Last Posted Date
- 2014-07-02
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 2055
- Registration Number
- NCT00657150
- Locations
- 🇺🇸
1160.64.01003 Boehringer Ingelheim Investigational Site, Missoula, Montana, United States
🇺🇸1160.64.01002 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
🇨🇦1160.64.6011 Boehringer Ingelheim Investigational Site, Oshawa, Ontario, Canada
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.