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
Overview
- Phase
- Phase 2
- Intervention
- Dabigatran Etexilate
- Conditions
- Arthroplasty, Replacement, Knee
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 512
- Locations
- 38
- Primary Endpoint
- Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dabigatran etexilate 110 mg
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Intervention: Dabigatran Etexilate
Dabigatran etexilate 150 mg
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Intervention: Dabigatran Etexilate
Dabigatran etexilate 220 mg
Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration
Intervention: Dabigatran Etexilate
Placebo
matching placebo capsule, once a day, oral administration
Intervention: placebo
Outcomes
Primary Outcomes
Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
Time Frame: 2 weeks study medication
number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality
Secondary Outcomes
- Volume of Blood Loss(Day 0)
- Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality(2 weeks)
- Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period(2 weeks)
- Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)(2 weeks)
- Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period(2 weeks)
- Number of Participants With Pulmonary Embolism During Treatment Period(2 weeks)
- Number of Participants Who Died During Treatment Period(2 weeks)
- Number of Participants With Bleeding Events During Treatment Period(2 weeks)
- Blood Transfusion(Day 0)
- Laboratory Analyses(First administration to end of study)