Dabigatran

Generic Name: Dabigatran

Brand Names: Dabigatran Etexilate Leon Farma, Dabigatran Etexilate Accord, Pradaxa

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₅N_₇O_₃

CAS Number: 211914-51-1

Unique Ingredient Identifier: I0VM4M70GC

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

Clinical Trials

Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively

Phase 2

Terminated

Conditions: Primary Disease

Interventions: Drug: Dabigatran
Drug: Warfarin

First Posted Date: 2013-06-04

Last Posted Date: 2015-10-09

Lead Sponsor: Hospital Ana Nery

Target Recruit Count: 27

Registration Number: NCT01868243

Locations: 🇧🇷
Hospital Ana Nery, Salvador, Bahia, Brazil

Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Placebo
Drug: Dabigatran

First Posted Date: 2013-05-13

Last Posted Date: 2015-03-17

Lead Sponsor: University of Florida

Target Recruit Count: 35

Registration Number: NCT01852162

Locations: 🇺🇸
University of Florida, Jacksonville, Florida, United States

Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke

Phase 2

Completed

Conditions: Transient Ischemic Attack
Minor Ischemic Stroke

Interventions: Drug: Dabigatran 110/150 mg BID

First Posted Date: 2013-01-17

Last Posted Date: 2014-10-30

Lead Sponsor: University of Alberta

Target Recruit Count: 53

Registration Number: NCT01769703

Locations: 🇨🇦
University of Alberta, Edmonton, Alberta, Canada

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran
Drug: Placebo
Drug: BI 655075

First Posted Date: 2012-09-20

Last Posted Date: 2016-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 157

Registration Number: NCT01688830

Locations: 🇧🇪
1321.1.1 Boehringer Ingelheim Investigational Site, Antwerpen, Belgium

Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

Phase 3

Completed

Conditions: Hematoma

Interventions: Drug: Dabigatran
Drug: Rivaroxaban
Drug: Apixaban

First Posted Date: 2012-08-29

Last Posted Date: 2019-10-07

Lead Sponsor: Ottawa Heart Institute Research Corporation

Target Recruit Count: 663

Registration Number: NCT01675076

Locations: 🇨🇦
Victoria Cardiac Arrhythmia Trials Inc., Victoria, British Columbia, Canada
🇨🇦
University of Alberta-ECAT Group, Edmonton, Alberta, Canada
🇨🇦
Hamilton Health Sciences General Campus, Hamilton, Ontario, Canada

and more 12 locations

Management of Myocardial Injury After Noncardiac Surgery Trial

Phase 3

Completed

Conditions: Myocardial Injury After Noncardiac Surgery (MINS)

Interventions: Drug: Placebo (for Dabigatran)
Drug: Placebo (for Omeprazole)
Drug: Dabigatran
Drug: Omeprazole

First Posted Date: 2012-08-09

Last Posted Date: 2018-03-26

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 1754

Registration Number: NCT01661101

Locations: 🇵🇪
Hospital Nacional Cayetano Heredia, Lima, Peru
🇦🇷
Instituto Cardiovascular de Buenos Aires, Caba, Buenos Aires, Argentina
🇦🇷
Clinica Parra - Centro de Investigaciones, Rafaela, Santa Fe, Argentina

and more 79 locations

An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients

Phase 1

Completed

Conditions: Blood Coagulation Disorders

Interventions: Drug: Dabigatran Etexilate 110 mg

First Posted Date: 2012-05-03

Last Posted Date: 2012-11-01

Lead Sponsor: Nova Scotia Health Authority

Target Recruit Count: 10

Registration Number: NCT01590823

Locations: 🇨🇦
Capital Health District Authority, Department of Medicine, Division of Nephrology, Halifax, Nova Scotia, Canada

Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation

Phase 4

Terminated

Conditions: Atrial Fibrillation

Interventions: Drug: Dabigatran etexilate (Pradaxa)

First Posted Date: 2012-03-07

Last Posted Date: 2015-10-12

Lead Sponsor: University of Utah

Target Recruit Count: 14

Registration Number: NCT01546883

Locations: 🇺🇸
University of Utah, Salt Lake City, Utah, United States

Follow on Study From RE-ALIGN

Phase 2

Terminated

Conditions: Heart Valve Prosthesis
Thromboembolism

Interventions: Drug: warfarin 5mg
Drug: dabigatran etexilate low dose
Drug: dabigatran etexilate intermediate dose
Drug: warfarin 1mg
Drug: warfarin 3mg
Drug: dabigatran etexilate high dose

First Posted Date: 2012-01-09

Last Posted Date: 2014-07-11

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 158

Registration Number: NCT01505881

Locations: 🇨🇦
1160.138.11009 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada
🇨🇦
1160.138.11001 Boehringer Ingelheim Investigational Site, Saint John, New Brunswick, Canada
🇨🇦
1160.138.11012 Boehringer Ingelheim Investigational Site, Newmarket, Ontario, Canada

and more 27 locations

Reversal of the Antithrombotic Action of New Oral Anticoagulants

Phase 4

Conditions: Thrombosis
Anticoagulant-induced Bleeding
Anticoagulant Overdosage
Hemorrhage

Interventions: Drug: Rivaroxaban
Drug: Dabigatran

First Posted Date: 2011-11-23

Last Posted Date: 2012-03-12

Lead Sponsor: Gines Escolar

Target Recruit Count: 10

Registration Number: NCT01478282

Locations: 🇪🇸
Hospital Clinic, Fundació Clinic (FCRB), Barcelona, Spain

Drug Development Updates

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