NCT00937820已完成3 期
YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism
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
- 87
- 主要终点
- Joint incidence of deep vein thromboembolism or pulmonary thromboembolism
研究概览
简要总结
The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.
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
- •Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
- •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, retinopathy, 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
Joint incidence of deep vein thromboembolism or pulmonary thromboembolism
时间窗: 52 weeks
次要结局
- Incidence of bleeding event(52 weeks)
- All cause mortality(52 weeks)
- Incidence of each thromboembolism(52 weeks)
研究者
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