NCT01452347

Dabigatran Etexilate in Patients With Mechanical Heart Valves

A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DRUG	warfarin 1mg	comparator warfarin
DRUG	dabigatran etexilate intermediate dose	active treatment (medium)
DRUG	dabigatran etexilate low dose	active treatment (low)
DRUG	warfarin 5mg	comparator warfarin
DRUG	dabigatran etexilate high dose	active treatment (high)
DRUG	warfarin 3mg	comparator warfarin

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-10-14
• Last updated: 2014-08-06
• Results posted: 2014-08-06

Locations

40 sites across 10 countries: Belgium, Canada, Czechia, Denmark, France, Germany, Netherlands, Norway, Poland, Sweden