NCT00937911已完成3 期
YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Incidence of venous thromboembolism
研究概览
简要总结
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
- •Written informed consent obtained before screening
排除标准
- •Subject has history of deep vein thrombosis and/or pulmonary embolism
- •Subject has a hemorrhagic disorder and/or coagulation disorder
- •Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
- •Subject has an acute bacterial endocarditis
- •Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
- •Subject is receiving anticoagulants/antiplatelet agents
- •Subject has a body weight less than 40 kg
研究组 & 干预措施
YM150 group
Experimental
干预措施: YM150 (Drug)
结局指标
主要结局
Incidence of venous thromboembolism
时间窗: Until day 12
次要结局
- Incidence of deep vein thrombosis(Until day 35)
- Incidence of pulmonary embolism(Until day 35)
- All cause mortality(Until day 35)
- Incidence of bleeding event(Until day 35)
研究者
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