BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,973
- 试验地点
- 59
- 主要终点
- Number of Participants With Venous Thromboembolic (VTE) Events
研究概览
简要总结
The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.
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
- 18 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
BIBR 1048 50 mg bis in die(b.i.d)
BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period
干预措施: BIBR 1048 (Drug)
BIBR 1048 150 mg b.i.d
BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period
干预措施: BIBR 1048 (Drug)
BIBR 1048 225 mg b.i.d
BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period
干预措施: BIBR 1048 (Drug)
BIBR 1048 300 mg quaque die(q.d)
BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period
干预措施: BIBR 1048 (Drug)
Enoxaparin 40 mg subcutaneous(s.c)
placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Number of Participants With Venous Thromboembolic (VTE) Events
时间窗: Treatment period (up to day 8+/-2 days visit)
Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing
Number of Participants With Major Bleeding Events (MBE)
时间窗: From approximately 14 days prior to surgery to 4-6 weeks post surgery
次要结局
- Number of Participants With VTE Events and All Cause Mortality(Treatment period (up to day 8+/-2 days visit))
- Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality(Treatment period (up to day 10))
- Number of Participants With Proximal DVT(Treatment period (up to day 8+/-2 days visit))
- Volume of Blood Loss(Day 1 (Day of surgery))
- Rate of Transfusions Due to Bleedings(Day 1 (Day of surgery))
- Number of Participants With Clinically Significant, Minor or Any Bleeding Events(Treatment period (up to day 8+/-2 days visit))
- Laboratory Analyses(Screening to end of treatment)
- Plasma Concentration (Cmax) of Dabigatran(Day 1 to end of treatment)
- Area Under the Plasma Concentration-time Curve During a Dosing Interval(up to day 8+/-2 days visit)