drugset / Trial / NCT01452347

Dabigatran Etexilate in Patients With Mechanical Heart Valves

NCT01452347

Phase 2 Terminated 328 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelPrevention

Summary

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Timeline

Start
2011-10
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 150 mg Oral
Subject Dabigatran etexilate Unknown 220 mg Oral
Subject Dabigatran etexilate Unknown 300 mg Oral
Comparator Warfarin Small molecule 1 mg
Comparator Warfarin Small molecule 3 mg
Comparator Warfarin Small molecule 5 mg

Indications