drugset / Trial / NCT00246025

A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

NCT00246025

Phase 2 Completed 512 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindPrevention

Summary

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Timeline

Start
2005-10
Primary completion
2007-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 110 mg Oral
Subject Dabigatran etexilate Unknown 150 mg Oral
Subject Dabigatran etexilate Unknown 220 mg Oral