NCT00973245已完成2 期
BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation
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
- 102
- 主要终点
- (Safety) Incidence of bleeding
研究概览
简要总结
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).
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
- 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
- •Japanese subjects with non-valvular AF who met all of the following criteria:
- •Male subjects aged 20 years or older and postmenopausal female subjects
- •Subjects with persistent or paroxysmal non-valvular AF with >/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
- •Subjects who were at risk for stroke as follows:
- •Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
- •Subjects aged 60 years old and above regardless of the existence of above risk factors.
排除标准
- •History or presence of stroke or transient ischemic attack.
- •History of intracerebral hemorrhage.
- •History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 2
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 4
Active Comparator
干预措施: Warfarin (Drug)
Arm 3
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
结局指标
主要结局
(Safety) Incidence of bleeding
时间窗: Throughout treatment and followup period
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
时间窗: Day 14 and Day 28
次要结局
未报告次要终点
研究者
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