NCT01028950已完成3 期
A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
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
- 52
- 主要终点
- Composite assessment of VTE events and all cause death
研究概览
简要总结
To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
- •Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
- •Written informed consent obtained
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 obtaining informed consent
- •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
- •Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods
研究组 & 干预措施
YM150 group
Experimental
干预措施: YM150 (Drug)
结局指标
主要结局
Composite assessment of VTE events and all cause death
时间窗: Until day 28
次要结局
- Incidence of bleeding events(Until day 28)
研究者
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