NCT00246025

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

A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroplasty, Replacement, Knee
• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Dabigatran etexilate	Dabigatran etexilate 110 mg capsule, once a day, oral administration
DRUG	Dabigatran etexilate	Dabigatran etexilate 150 mg capsule, once a day, oral administration
DRUG	Dabigatran Etexilate	Dabigatran etexilate 220 mg capsule, once a day, oral administration
DRUG	placebo	matching placebo capsule, once a day, oral administration

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-06-01
• First posted: 2005-10-31
• Last updated: 2014-06-09
• Results posted: 2010-12-17

Locations

38 sites across 1 country: Japan