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
- -
Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2014-06-23
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 24
- Registration Number
- NCT02171026
Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2014-06-23
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 24
- Registration Number
- NCT02170675
Relative Bioavailability of Dabigatran and Digoxin in Healthy Male and Female Volunteers
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2014-06-23
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 24
- Registration Number
- NCT02171052
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2014-06-23
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 24
- Registration Number
- NCT02170571
Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
- First Posted Date
- 2014-01-24
- Last Posted Date
- 2015-05-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 54
- Registration Number
- NCT02044367
- Locations
- 🇩🇪
1160.194.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
- Conditions
- Interventions
- First Posted Date
- 2013-07-11
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 267
- Registration Number
- NCT01895777
- Locations
- 🇦🇷
Hospital General de Niños Pedro de Elizalde, Caba, Argentina
🇧🇪UZ Leuven, Leuven, Belgium
🇦🇹AKH - Medical University of Vienna, Wien, Austria
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
- First Posted Date
- 2013-01-23
- Last Posted Date
- 2015-10-26
- Lead Sponsor
- Boehringer Ingelheim
- Registration Number
- NCT01773174
- Locations
- 🇺🇸
1160.145.00007 Boehringer Ingelheim Investigational Site, Newark, New Jersey, United States
🇺🇸1160.145.00010 Boehringer Ingelheim Investigational Site, Sacramento, California, United States
🇺🇸1160.145.00009 Boehringer Ingelheim Investigational Site, Louisville, Kentucky, United States
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
- First Posted Date
- 2012-11-28
- Last Posted Date
- 2014-05-05
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 48
- Registration Number
- NCT01734772
- Locations
- 🇩🇪
1160.142.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
- First Posted Date
- 2012-10-22
- Last Posted Date
- 2015-01-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 19
- Registration Number
- NCT01711853
- Locations
- 🇳🇱
1160.166.31001 Boehringer Ingelheim Investigational Site, Leiden, Netherlands
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
- First Posted Date
- 2012-05-10
- Last Posted Date
- 2013-08-22
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 36
- Registration Number
- NCT01595854
- Locations
- 🇩🇪
1160.141.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Drug Development Updates
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