Conditions: Arthroplasty, Replacement, Knee Venous Thrombosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 512
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Dabigatran etexilate 110 mg capsule, once a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, once a day, oral administration arm 3: Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration arm 4: matching placebo capsule, once a day, oral administration

Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran Etexilate intervention 4: placebo
Intervention descriptions: intervention 1: Dabigatran etexilate 110 mg capsule, once a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, once a day, oral administration intervention 3: Dabigatran etexilate 220 mg capsule, once a day, oral administration intervention 4: matching placebo capsule, once a day, oral administration

Protocol document: