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

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Phase 3

Completed

Conditions: Secondary Prevention
Stroke

Interventions: Drug: optional ASA as comedication
Drug: placebo to optional ASA as comedication
Drug: placebo to ASA
Drug: placebo to dabigatran etexilate
Drug: ASA 100 mg
Drug: dabigatran etexilate

First Posted Date: 2014-09-12

Last Posted Date: 2019-09-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 5390

Registration Number: NCT02239120

Locations: 🇩🇪
Klinikum Coburg gGmbH, Coburg, Germany
🇩🇪
Klinikzentrum Mitte, Dortmund, Dortmund, Germany
🇩🇪
Klinikum Hanau GmbH, Hanau, Germany

and more 559 locations

Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

Phase 2

Completed

Conditions: Venous Thromboembolism

Interventions: Drug: dabigatran

First Posted Date: 2014-08-22

Last Posted Date: 2016-09-20

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 8

Registration Number: NCT02223260

Locations: 🇫🇷
1160.105.33001 Boehringer Ingelheim Investigational Site, Paris, France
🇨🇦
1160.105.10002 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada
🇨🇦
1160.105.10003 Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada

and more 1 locations

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With and Without Renal Impairment

Phase 1

Completed

Conditions: Renal Insufficiency

Interventions: Drug: Dabigatran etexilate high dose
Drug: Dabigatran etexilate low dose

First Posted Date: 2014-07-08

Last Posted Date: 2014-07-18

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 35

Registration Number: NCT02182024

BIBR 953 ZW in Healthy Elderly Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIBR 1048 MS
Drug: Pantoprazole

First Posted Date: 2014-06-25

Last Posted Date: 2014-06-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 36

Registration Number: NCT02173730

Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate generation I
Drug: Dabigatran etexilate generation II

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 66

Registration Number: NCT02171520

Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran high dose
Drug: Dabigatran low dose

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 48

Registration Number: NCT02171468

Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate capsules
Drug: Fexofenadine tablets
Drug: Quinidine sulfate tablets

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 42

Registration Number: NCT02171546

Single and Multiple Oral Doses of Dabigatran Etexilate in Healthy Chinese Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate low
Drug: Dabigatran etexilate high

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 28

Registration Number: NCT02171572

Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Enoxaparin prefilled syringes
Drug: Dabigatran etexilate capsules

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 29

Registration Number: NCT02171559

Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate high dose
Drug: Dabigatran etexilate low dose
Drug: Dabigatran etexilate medium dose
Drug: Placebo

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 10

Registration Number: NCT02171455

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