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Dabigatran

Generic Name
Dabigatran
Brand Names
Dabigatran Etexilate Leon Farma, Dabigatran Etexilate Accord, Pradaxa
Drug Type
Small Molecule
Chemical Formula
C25H25N7O3
CAS Number
211914-51-1
Unique Ingredient Identifier
I0VM4M70GC
Background

Dabigatran is the active form of the orally bioavailable prodrug dabigatran etexilate.

Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

Terminated
Conditions
Venous Thromboembolism
Arthroplasty, Replacement
Interventions
First Posted Date
2010-06-30
Last Posted Date
2023-10-03
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
167
Registration Number
NCT01153698
Locations
🇦🇹

1160.118.43007 Boehringer Ingelheim Investigational Site, Wien, Austria

🇦🇹

1160.118.43004 Boehringer Ingelheim Investigational Site, Braunau, Austria

🇦🇹

1160.118.43016 Boehringer Ingelheim Investigational Site, Stolzalpe, Austria

and more 4 locations

Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

Phase 2
Completed
Conditions
Heart Catheterization
Interventions
First Posted Date
2009-01-08
Last Posted Date
2014-06-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
53
Registration Number
NCT00818753
Locations
🇳🇱

1160.73.31003 Boehringer Ingelheim Investigational Site, Nieuwegein, Netherlands

🇳🇱

1160.73.31002 Boehringer Ingelheim Investigational Site, Rotterdam, Netherlands

🇳🇱

1160.73.31004 Boehringer Ingelheim Investigational Site, Alkmaar, Netherlands

and more 1 locations

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

Phase 3
Completed
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2008-12-15
Last Posted Date
2014-06-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
5897
Registration Number
NCT00808067
Locations
🇺🇸

1160.71.0119 Boehringer Ingelheim Investigational Site, Tupelo, Mississippi, United States

🇺🇸

1160.71.0038 Boehringer Ingelheim Investigational Site, Hot Springs, Arkansas, United States

🇺🇸

1160.71.0482 Boehringer Ingelheim Investigational Site, Guilford, Connecticut, United States

and more 564 locations

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

Phase 3
Completed
Conditions
Venous Thromboembolism
Interventions
Drug: matching placebo twice daily (BID)
First Posted Date
2007-11-14
Last Posted Date
2014-06-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1353
Registration Number
NCT00558259
Locations
🇺🇸

1160.63.01002 Boehringer Ingelheim Investigational Site, Laguna Hills, California, United States

🇺🇸

1160.63.01020 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States

🇺🇸

1160.63.01032 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States

and more 144 locations

Secondary Prevention of Venous Thrombo Embolism (VTE).

Phase 3
Completed
Conditions
Thromboembolism
Interventions
First Posted Date
2006-05-24
Last Posted Date
2014-05-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2867
Registration Number
NCT00329238
Locations
🇺🇸

1160.47.01030 Boehringer Ingelheim Investigational Site, Grand Forks, North Dakota, United States

🇨🇦

1160.47.02019 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada

🇲🇽

1160.47.52030 Boehringer Ingelheim Investigational Site, Guadalajara, Jal., Mexico

and more 272 locations

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

Phase 3
Completed
Conditions
Thromboembolism
Interventions
First Posted Date
2006-02-14
Last Posted Date
2014-06-06
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2564
Registration Number
NCT00291330
Locations
🇺🇸

1160.53.01033 Boehringer Ingelheim Investigational Site, Sarasota, Florida, United States

🇺🇸

1160.53.01046 Boehringer Ingelheim Investigational Site, Sarasota, Florida, United States

🇺🇸

1160.53.01010 Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States

and more 247 locations

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

Phase 3
Completed
Conditions
Atrial Fibrillation
Stroke
Interventions
First Posted Date
2005-12-07
Last Posted Date
2019-04-17
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
18113
Registration Number
NCT00262600
Locations
🇸🇪

1160.26.1633 Sahlgrenska Sjukhuset, Göteboerg, Sweden

🇺🇸

1160.26.0278 Boehringer Ingelheim Investigational Site, Bridgeport, Connecticut, United States

🇺🇸

1160.26.0358 Boehringer Ingelheim Investigational Site, Melbourne, Florida, United States

and more 981 locations

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

First Posted Date
2005-09-12
Last Posted Date
2014-05-05
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2615
Registration Number
NCT00152971
Locations
🇲🇽

1160.24.05009 Traumatologia, Planta Baja, Guadalajara, Jalisco, Mexico

🇺🇸

1160.24.01010 MIMA Century Research Associates, Melbourne, Florida, United States

🇺🇸

1160.24.01033 Bone and Joint Clinic of Houston, Houston, Texas, United States

and more 91 locations
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