NCT00779064已完成2 期
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 36
- 主要终点
- Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
研究概览
简要总结
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •20 years or older
- •Japanese male or female
- •Non- valvular atrial fibrillation documented by ECG
- •Patients aged 60 years and older or with a risk of stroke
排除标准
- •Prior stroke and TIA
- •Patients in whom anticoagulants are contraindicated
研究组 & 干预措施
Arm 1
Experimental
干预措施: Rivaroxaban (BAY59-7939) (Drug)
Arm 2
Experimental
干预措施: Rivaroxaban (BAY59-7939) (Drug)
结局指标
主要结局
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
时间窗: Day 14 and 28
次要结局
- Each category of bleeding events and adverse event(Throughout treatment and followup period)
研究者
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