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.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

Phase 4

Completed

Conditions: Atrial Fibrillation
Cardioembolic Events
Oral Anticoagulation

Interventions: Drug: Dabigatran

First Posted Date: 2014-02-20

Last Posted Date: 2022-11-07

Lead Sponsor: Georg Nickenig

Target Recruit Count: 200

Registration Number: NCT02067182

Locations: 🇩🇪
Heart Center Bad Neustadt-Saale, Bad Neustadt An Der Saale, Germany
🇩🇪
University Hospital Mannheim, Mannheim, Germany
🇩🇪
Heart Center Leipzig, Leipzig, Germany

and more 16 locations

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo to dose
Drug: Placebo to Idarucizumab
Drug: Idarucizumab
Drug: dabigatran

First Posted Date: 2014-01-07

Last Posted Date: 2016-02-11

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 80

Registration Number: NCT02028780

Locations: 🇯🇵
1321.5.00001 Boehringer Ingelheim Investigational Site, Sumida-ku, Tokyo, Japan

Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

Phase 4

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Dabigatran
Drug: Warfarin

First Posted Date: 2013-11-25

Last Posted Date: 2021-09-29

Lead Sponsor: University of Sao Paulo

Target Recruit Count: 200

Registration Number: NCT01994265

Locations: 🇧🇷
Federal Univeristy of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
🇧🇷
Heart Institute - University of São Paulo, São Paulo, Brazil

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

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

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

DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation

Phase 4

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: dabigatran

First Posted Date: 2011-11-09

Last Posted Date: 2017-11-06

Lead Sponsor: Lawson Health Research Institute

Target Recruit Count: 50

Registration Number: NCT01468155

Locations: 🇨🇦
London Health Sciences Center, London, Ontario, Canada

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