Dabigatran etexilate

Generic Name
Dabigatran etexilate
Brand Names
Pradaxa
Drug Type
Small Molecule
Chemical Formula
C34H41N7O5
CAS Number
211915-06-9
Unique Ingredient Identifier
2E18WX195X
Background

Dabigatran etexilate is an oral prodrug that is hydrolyzed to the competitive and reversible direct thrombin inhibitor dabigatran. Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients in whom anticoagulation therapy is indicated. In contrast to warfarin, because its anticoagulant effects are predictable, lab monit...

Indication

Dabigatran etexilate is available in both oral pellet and capsule form. Dabigatran etexilate pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients between three months and 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. They are also indicated in the same age group to re...

Associated Conditions
Deep Vein Thrombosis, Deep vein thrombosis recurrent, Pulmonary Embolism, Recurrent Pulmonary Embolism (Disorder), Recurrent Venous Thromboembolism, Stroke, Systemic Embolism, Venous Thromboembolism
Associated Therapies
-

Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

First Posted Date
2017-06-12
Last Posted Date
2017-06-12
Lead Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Target Recruit Count
40
Registration Number
NCT03183843
Locations
🇷🇺

Research Institute for Complex Problems of Cardiovascular Diseases, Kemerovo, Russian Federation

Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan

First Posted Date
2017-05-08
Last Posted Date
2019-01-16
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
36
Registration Number
NCT03143166
Locations
🇯🇵

Souseikai Hakata Clinic, Fukuoka, Fukuoka, Japan

Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State

First Posted Date
2017-03-22
Last Posted Date
2019-03-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
12
Registration Number
NCT03086356
Locations
🇨🇳

Peking University First Hospital, Beijing, China

Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-03-03
Last Posted Date
2019-01-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
160
Registration Number
NCT03070171
Locations
🇯🇵

SOUSEIKAI Sumida Hospital, Tokyo, Sumida-ku, Japan

Impact of Anticoagulation Therapy on the Cognitive Decline and Dementia in Patients With Non-Valvular Atrial Fibrillation

First Posted Date
2017-02-23
Last Posted Date
2021-09-02
Lead Sponsor
Intermountain Health Care, Inc.
Target Recruit Count
101
Registration Number
NCT03061006
Locations
🇺🇸

Intermountain Heart Institute, Murray, Utah, United States

Validation of Predictors of OAC Initiation Using EMR Data

First Posted Date
2016-12-30
Last Posted Date
2019-03-22
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
140187
Registration Number
NCT03006341
Locations
🇺🇸

Brigham & Women's Hospital, Boston, Massachusetts, United States

Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy

First Posted Date
2016-12-01
Last Posted Date
2016-12-20
Lead Sponsor
Meshalkin Research Institute of Pathology of Circulation
Target Recruit Count
200
Registration Number
NCT02979561
Locations
🇷🇺

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology, Novosibirsk, Russian Federation

A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-09-23
Last Posted Date
2019-08-15
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
120
Registration Number
NCT02913326
Locations
🇮🇳

Caritas Hospital, Kottayam, India

🇮🇳

Mazumdar Shaw Medical centre, Bangalore, India

🇮🇳

Nizam's Institute of Medical Sciences, Hyderabad, India

and more 33 locations

Comparison of Efficacy and Safety Among Dabigatran, Rivaroxaban, and Apixaban in Non-Valvular Atrial Fibrillation

First Posted Date
2016-01-28
Last Posted Date
2016-02-17
Lead Sponsor
National Cheng-Kung University Hospital
Target Recruit Count
3672
Registration Number
NCT02666157
Locations
🇨🇳

E-DA Hospital, Kaohsiung, Taiwan

🇨🇳

National Cheng Kung University Hospital, Tainan, Tainan City, Taiwan

🇨🇳

Tainan Hospital Ministry of Health and Welfare, Tainan, Tainan City, Taiwan

and more 2 locations

The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation Patients

First Posted Date
2016-01-05
Last Posted Date
2016-01-05
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
210
Registration Number
NCT02646267
Locations
🇨🇳

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

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