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
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A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-10-05
Last Posted Date
2019-11-01
Lead Sponsor
AstraZeneca
Target Recruit Count
60
Registration Number
NCT02568397
Locations
🇺🇸

Covance, Dallas, Texas, United States

Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma

First Posted Date
2015-04-24
Last Posted Date
2018-07-13
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
15
Registration Number
NCT02426229
Locations
🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF

First Posted Date
2014-10-06
Last Posted Date
2019-07-26
Lead Sponsor
Johannes Gutenberg University Mainz
Target Recruit Count
64
Registration Number
NCT02256683
Locations
🇩🇪

Universitätsmedizin Leipzig, Leipzig, Germany

🇩🇪

Charité Universitätsmedizin Berlin, Berlin, Germany

🇩🇪

University Heart Center; Department of Cardiology and Angiology II, Bad Krozingen, Germany

and more 11 locations

Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)

First Posted Date
2014-09-16
Last Posted Date
2019-04-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1506
Registration Number
NCT02240667

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

First Posted Date
2014-09-12
Last Posted Date
2019-09-06
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
5390
Registration Number
NCT02239120
Locations
🇩🇪

Klinikum Coburg gGmbH, Coburg, Germany

🇩🇪

Klinikzentrum Mitte, Dortmund, Dortmund, Germany

🇩🇪

Klinikum Hanau GmbH, Hanau, Germany

and more 559 locations

Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

First Posted Date
2014-07-22
Last Posted Date
2020-06-04
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
214
Registration Number
NCT02197416
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇨🇦

Kingston General Hospital, Kingston, Ontario, Canada

🇱🇹

Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius, Vilnius, Lithuania

and more 59 locations

Relative Bioavailability of Single Doses of Dabigatran Etexilate in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-06-25
Last Posted Date
2014-06-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
24
Registration Number
NCT02173717

Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-06-24
Last Posted Date
2014-06-24
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
42
Registration Number
NCT02171624

Bioavailability of Dabigatran With or Without Clarithromycin in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-06-24
Last Posted Date
2014-06-24
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
20
Registration Number
NCT02171585
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