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
-

RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-02-22
Last Posted Date
2014-03-12
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1878
Registration Number
NCT00621855
Locations
🇨🇦

1160.67.11020 Boehringer Ingelheim Investigational Site, Sudbury, Ontario, Canada

🇨🇦

1160.67.11018 Boehringer Ingelheim Investigational Site, London, Ontario, Canada

🇧🇪

1160.67.32003 Boehringer Ingelheim Investigational Site, Hasselt, Belgium

and more 164 locations

A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

First Posted Date
2005-10-30
Last Posted Date
2014-06-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
512
Registration Number
NCT00246025
Locations
🇯🇵

1160.50.030 Boehringer Ingelheim Investigational Site, Okayama, Okayama, Japan

🇯🇵

1160.50.015 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan

🇯🇵

1160.50.016 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan

and more 35 locations

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

First Posted Date
2005-09-15
Last Posted Date
2014-05-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
3494
Registration Number
NCT00168818
Locations
🇦🇺

1160.48.06102 Monash Medical Centre, Clayton, Victoria, Australia

🇦🇺

1160.48.06104 Ecru, Box Hill, Victoria, Australia

🇦🇺

1160.48.06110 Suite 13 level 4, Lismore, New South Wales, Australia

and more 113 locations

RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

First Posted Date
2005-09-15
Last Posted Date
2014-05-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2101
Registration Number
NCT00168805
Locations
🇦🇺

1160.25.06103 Boehringer Ingelheim Investigational Site, Ringwood East, Victoria, Australia

🇦🇹

1160.25.04303 Boehringer Ingelheim Investigational Site, Wels, Austria

🇨🇿

1160.25.42010 Boehringer Ingelheim Investigational Site, Chomutov, Czech Republic

and more 102 locations

Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2005-09-12
Last Posted Date
2014-05-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
361
Registration Number
NCT00157248
Locations
🇺🇸

1160.42.10013 Boehringer Ingelheim Investigational Site, New Hyde Park, New York, United States

🇳🇱

1160.42.31008 Gelre Ziekenhuis, locatie Juliana, Apeldoorn, Netherlands

🇩🇰

1160.42.45005 Boehringer Ingelheim Investigational Site, Aarhus C, Denmark

and more 47 locations
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