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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 38
- 主要终点
- Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dabigatran etexilate 110 mg
Dabigatran etexilate 110 mg capsule, once a day, oral administration
干预措施: Dabigatran Etexilate (Drug)
Dabigatran etexilate 150 mg
Dabigatran etexilate 150 mg capsule, once a day, oral administration
干预措施: Dabigatran Etexilate (Drug)
Dabigatran etexilate 220 mg
Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration
干预措施: Dabigatran Etexilate (Drug)
Placebo
matching placebo capsule, once a day, oral administration
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
时间窗: 2 weeks study medication
number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality
次要结局
- 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)