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

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

Dabigatran Etexilate in Patients With Mechanical Heart Valves

Phase 2

Terminated

Conditions: Heart Valve Diseases

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

First Posted Date: 2011-10-14

Last Posted Date: 2014-08-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 328

Registration Number: NCT01452347

Locations: 🇧🇪
1160.113.32005 Boehringer Ingelheim Investigational Site, Gent, Belgium
🇨🇿
1160.113.42001 Boehringer Ingelheim Investigational Site, Prague 5, Czech Republic
🇧🇪
1160.113.32007 Boehringer Ingelheim Investigational Site, Brussel, Belgium

and more 37 locations

Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery

Phase 3

Completed

Conditions: Venous Thromboembolism

Interventions: Drug: Nadroparin
Drug: Dabigatran
Drug: Rivaroxaban

First Posted Date: 2011-09-09

Last Posted Date: 2018-06-07

Lead Sponsor: Martini Hospital Groningen

Target Recruit Count: 148

Registration Number: NCT01431456

Locations: 🇳🇱
Martini Ziekenhuis, Groningen, Netherlands

Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran then dabigatran and clarithromycin
Drug: Clarithromycin and dabigatran then dabigatran

First Posted Date: 2011-06-30

Last Posted Date: 2012-03-22

Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Target Recruit Count: 10

Registration Number: NCT01385683

Locations: 🇫🇷
Service de Medecine et Therapeutique, Saint-Etienne, France

Safety Study of Dabigatran in CADASIL

Phase 2

Conditions: CADASIL

Interventions: Drug: Dabigatran
Drug: Antiplatelets

First Posted Date: 2011-05-27

Last Posted Date: 2014-02-11

Lead Sponsor: S. Andrea Hospital

Target Recruit Count: 50

Registration Number: NCT01361763

Locations: 🇮🇹
Emergency Department Stroke Unit, Umberto I Hospital, Rome, Italy
🇮🇹
NESMOS Department St. Andrea Hospital, Rome, Italy

Impact of Dabigatran and Phenprocoumon on Clopidogrel Mediated ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation

Phase 4

Terminated

Conditions: Acute Coronary Syndrome
Coronary Heart Disease
Atrial Fibrillation
Atherosclerosis

Interventions: Drug: Dabigatran
Drug: Phenprocoumon

First Posted Date: 2011-05-12

Last Posted Date: 2015-02-05

Lead Sponsor: Deutsches Herzzentrum Muenchen

Target Recruit Count: 46

Registration Number: NCT01352702

Locations: 🇩🇪
Deutsches Herzzentrum Muenchen, Munich, Germany

Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation

Phase 4

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Phenprocoumon
Drug: Dabigatran

First Posted Date: 2011-04-21

Last Posted Date: 2013-07-02

Lead Sponsor: Deutsches Herzzentrum Muenchen

Target Recruit Count: 70

Registration Number: NCT01339819

Locations: 🇩🇪
Deutsches Herzzentrum Muenchen, Munich, Germany

Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate
Drug: Dabigatran etexilate plus dronedarone

First Posted Date: 2011-03-01

Last Posted Date: 2014-06-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 36

Registration Number: NCT01306162

Locations: 🇩🇪
1160.112.1 Boehringer Ingelheim Investigational Site, Ulm, Germany

PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin

Phase 2

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: dabigatran with ASA
Drug: dabigatran without ASA
Drug: warfarin

First Posted Date: 2010-10-25

Last Posted Date: 2014-05-05

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 502

Registration Number: NCT01227629

Locations: 🇺🇸
1160.20.10015, Baltimore, Maryland, United States
🇩🇰
1160.20.45010, Aalborg, Denmark
🇩🇰
1160.20.45005 Aarhus Sygehus, Aarhus C, Denmark

and more 35 locations

Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics

Phase 4

Completed

Conditions: Venous Thromboembolism

Interventions: Drug: Dabigatran; Rivaroxaban
Drug: Rivaroxaban, Dabigatran

First Posted Date: 2010-09-28

Last Posted Date: 2011-07-01

Lead Sponsor: University Hospital, Grenoble

Target Recruit Count: 10

Registration Number: NCT01210755

Locations: 🇫🇷
Clinical Research Centre, University Hospital Grenoble, Grenoble, France

Drug Development Updates

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