A Phase 2, Randomized, Parallel Group, Multi-Center, Multi-National Study for the Evaluation of Safety and Efficacy of Two Fixed Dosages of DU-176b in Subjects With Non-Valvular Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 主要终点
- Incidence of All Bleeding
研究概览
简要总结
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 to 80 years of age
- •Non-valvular AF supported by abnormal ECG documented for two times (interval of more than 1 week) within 6 months prior to randomization.
- •CHADS2 Score of at least 1.
排除标准
- •Subjects with mitral valve disease
- •Subjects with previous valvular heart surgery
- •Contraindication for anticoagulants
- •Conditions associated with high risk of bleeding
- •Acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI, stroke, transient ischemic attack (TIA) or coronary artery/cardiac/other major surgery within the previous 30 days
- •Active infective endocarditis or life-expectancy < 12 months
研究组 & 干预措施
2
DU-176b tablets: high-dose
干预措施: DU-176b tablets (Drug)
3
Warfarin tablets
干预措施: Warfarin tablets (Drug)
1
DU-176b tablets: low-dose
干预措施: DU-176b tablets (Drug)
结局指标
主要结局
Incidence of All Bleeding
时间窗: 6 months
Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.
次要结局
- Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition(6 months)
- Evaluation of Effects on Biomarkers of Thrombus Formation(6 months)
- Evaluation of Effects on Pharmacodynamic Biomarkers(6 months)
- Evaluation of All Clinical and Laboratory Safety Data.(6 months)
- Evaluation of Plasma Concentration of DU-176(6 months)