Product
Dabigatran Etexilate
Aliases
Dabigatran Etexilate (DE), Dabigatran Etexilate Oral Capsule, Pradaxa, Pradaxa®
Name
Pradaxa
INN Name
dabigatran etexilate mesylate
FDA Approved
Yes
12 clinical trials
4 organizations
19 indications
1 document
Indication
Venous ThromboembolismIndication
HealthyIndication
Healthy Control ParticipantsIndication
Colorectal CancerIndication
Cushing's syndromeIndication
CancerIndication
Varicose VeinsIndication
Healthy VolunteerIndication
DabigatranIndication
Bioequivalence StudyIndication
healthIndication
Atrial FibrillationIndication
Atrial flutterIndication
Deep Vein ThrombosisIndication
Pulmonary EmbolismIndication
Device Related ThrombusIndication
Left Atrial Appendage ThrombosisClinical trial
Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data CollectionStatus: Recruiting, Estimated PCD: 2024-10-01
Clinical trial
An Open-Label, 2-Part Study to Investigate the Effect of Lasmiditan on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy VolunteersStatus: Completed, Estimated PCD: 2021-07-06
Clinical trial
A Phase 1, Multi-center, Open-label, 3-arm, Fixed Sequence Study to Assess the Effect of Co-administration of AZD9833 on the Pharmacokinetics of Midazolam (CYP3A4/5 Substrate), of Omeprazole (CYP2C19 Substrate), of Celecoxib (CYP2C9 Substrate) and of Dabigatran Etexilate (P-gp Transporter Substrate) in Healthy Postmenopausal Female VolunteersStatus: Completed, Estimated PCD: 2022-12-13
Clinical trial
An Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy SubjectsStatus: Completed, Estimated PCD: 2022-07-19
Clinical trial
A Phase 1, Open-label, 2-part, 2-period Fixed-sequence Study to Evaluate the Effect of Fruquintinib on the Pharmacokinetics of Dabigatran Etexilate (A P-GP Substrate) and Rosuvastatin (A BCRP Substrate) in Healthy SubjectsStatus: Completed, Estimated PCD: 2022-04-22
Clinical trial
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled TrialStatus: Recruiting, Estimated PCD: 2026-06-30
Clinical trial
A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product (Pradaxa®) in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump InhibitorStatus: Not yet recruiting, Estimated PCD: 2024-10-08
Clinical trial
A Prospective, Single-Center, Open-Label Study of the Effect of Oral D-mannose Tablets on the Pharmacokinetics of Dabigatran Etexilate in Healthy AdultsStatus: Recruiting, Estimated PCD: 2024-11-30
Clinical trial
Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of DabigatranStatus: Not yet recruiting, Estimated PCD: 2025-06-10
Clinical trial
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF).Status: Recruiting, Estimated PCD: 2027-10-30
Clinical trial
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism.Status: Recruiting, Estimated PCD: 2027-03-31
Clinical trial
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).Status: Completed, Estimated PCD: 2023-12-31
Document
DailyMed Label: PradaxaOrganization
A-S Medication SolutionsOrganization
Rebel Distributors Corp.Organization
Boehringer Ingelheim Pharmaceuticals Inc.Organization
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