At a glance
ClinicalIndex Comparison Record- ✓Scheduled for primary, unilateral elective total knee replacement
- ✓Age ≥20 years
- ✓Weight ≥40 kg
- ✕History of bleeding diathesis
- ✕Constitutional or acquired coagulation disorders posing excessive bleeding risk
- ✕Major surgery or trauma within 3 months
- ✕Unstable cardiovascular disease, uncontrolled hypertension, or MI within 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Dabigatran etexilate, Dabigatran Etexilate, and 1 other intervention for Arthroplasty, Replacement, Knee and Venous Thrombosis. Completed, enrolled 512 participants across 38 sites.
Detailed 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.
Study Details
Timeline
Interventions
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Dabigatran etexilate 220 mg capsule, once a day, oral administration
matching placebo capsule, once a day, oral administration