DeepMed Research

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

Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS
Drug: Ranitidine

First Posted Date: 2014-06-23

Last Posted Date: 2014-06-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 30

Registration Number: NCT02170792

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Phase 3

Completed

Conditions: Percutaneous Coronary Intervention
Atrial Fibrillation

Interventions: Drug: Warfarin 3mg
Drug: Dabigatran Etexilate 110mg
Drug: Dabigatran Etexilate 150mg
Drug: Clopidogrel or Ticagrelor
Drug: Aspirin
Drug: Warfarin 5mg
Drug: Warfarin 1mg

First Posted Date: 2014-06-17

Last Posted Date: 2018-07-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 2725

Registration Number: NCT02164864

Locations: 🇫🇷
CLI du Pont de Chaume, Montauban, France
🇨🇿
Hospital Jihlava, Jihlava, Czechia
🇩🇪
Klinikum Coburg gGmbH, Coburg, Germany

and more 415 locations

Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

Completed

Conditions: Hemorrhage
Atrial Fibrillation

Interventions: Drug: Dabigatran 75 mg
Drug: Dabigatran 150 mg

First Posted Date: 2014-05-29

Last Posted Date: 2016-04-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 191

Registration Number: NCT02149303

Locations: 🇺🇸
1160.200.01 Boehringer Ingelheim Investigational Site, Brooklyn, New York, United States
🇺🇸
1160.200.05 Boehringer Ingelheim Investigational Site, Stony Brook, New York, United States
🇺🇸
1160.200.06 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States

and more 2 locations

Drug Interaction Study Between Bosutinib And Dabigatran

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran
Drug: Bosutinib

First Posted Date: 2014-04-03

Last Posted Date: 2014-06-24

Lead Sponsor: Pfizer

Target Recruit Count: 27

Registration Number: NCT02102633

Locations: 🇺🇸
Pfizer Investigational Site, DeLand, Florida, United States

Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

Not Applicable

Conditions: Hip Osteoarthritis
Blood Loss

Interventions: Drug: Enoxaparin
Drug: dabigatran
Drug: rivaroxaban

First Posted Date: 2014-03-13

Last Posted Date: 2014-03-14

Lead Sponsor: Centre of Postgraduate Medical Education

Target Recruit Count: 60

Registration Number: NCT02085824

Locations: 🇵🇱
Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education, Otwock, Woj. Mazowieckie, Poland

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

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

Phase 4

Completed

Conditions: Atrial Flutter
Atrial Fibrillation

Interventions: Drug: dabigatran etexilate mesylate

First Posted Date: 2013-11-05

Last Posted Date: 2017-09-12

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 101

Registration Number: NCT01976507

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

Phase 4

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Pradaxa, dabigatran etexilate

First Posted Date: 2013-07-11

Last Posted Date: 2016-11-30

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 63

Registration Number: NCT01896297

Locations: 🇺🇸
1160.173.026 Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States
🇺🇸
1160.173.011 Boehringer Ingelheim Investigational Site, Fort Worth, Texas, United States
🇺🇸
1160.173.019 Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States

and more 23 locations

Drug Development Updates

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