NCT00902928已完成2 期
A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery
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
- 1,992
- 主要终点
- Incidence of symptomatic Venous Thromboembolisms and death from all causes
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 hip replacement surgery
排除标准
- •Subject has active bleeding or any condition associated with increased risk of bleeding
- •Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
- •Subject has had an MI or stroke within 3 months before planned hip replacement surgery
研究组 & 干预措施
1. YM150, Dose X, twice daily
Experimental
干预措施: YM150 (Drug)
2, YM150, Dose X, 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 Y, once daily
Experimental
干预措施: YM150 (Drug)
5. Enoxaparin
Active Comparator
干预措施: enoxaparin (Drug)
结局指标
主要结局
Incidence of symptomatic Venous Thromboembolisms and death from all causes
时间窗: 12 days
次要结局
- Incidence of Bleeding events(During the treatment period, follow-up period and entire study period)
- Incidence of all Venous Thromboembolic events(Until day 12, during the treatment period, follow-up period and entire study period)
研究者
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