NCT00595426已完成2 期
A Phase 2b, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 685
- 主要终点
- The incidence of total venous thromboembolisms (VTE).
研究概览
简要总结
To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery
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 (Participant, Investigator)
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
- •Subject is scheduled for elective primary knee arthroplasty
- •Written Informed consent obtained
排除标准
- •Subject has documented history of previous VTE
- •Subject is considered to be at increased risk of VTE
- •Subject has active bleeding or any condition associated with increased risk of bleeding
- •Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study
研究组 & 干预措施
1. YM150 Dose X, twice daily
Experimental
干预措施: YM150 (Drug)
2. YM150 Dose Y, once daily
Experimental
干预措施: YM150 (Drug)
3. YM150 Dose Y, twice daily
Experimental
干预措施: YM150 (Drug)
4. YM150 Dose Z, once daily
Experimental
干预措施: YM150 (Drug)
5. Warfarin
Active Comparator
various doses
干预措施: Warfarin (Drug)
结局指标
主要结局
The incidence of total venous thromboembolisms (VTE).
时间窗: 6 Weeks
The incidence of bleeding events classified as major by the Adjudication Committee
时间窗: 6 Weeks
次要结局
- Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause(6 Weeks)
- Incidence of the bleeding types: major, clinically relevant nonmajor, minor(6 Weeks)
研究者
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