A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens 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
- 1,146
- 主要终点
- Adjudicated Incidence of Bleeding Events
研究概览
简要总结
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
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
- Double (Participant, Investigator)
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, 18 to 80 years old.
- •Able to provide written informed consent.
- •Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
- •A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2
排除标准
- •Subjects with mitral valve disease or previous valvular heart surgery
- •Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
- •Known or suspected hereditary or acquired bleeding or coagulation disorder
研究组 & 干预措施
1
DU-176b 30mg tablet once daily
干预措施: Edoxaban (DU-176b) (Drug)
2
DU-176b 60mg once daily
干预措施: Edoxaban (DU-176b) (Drug)
3
DU-176b 30mg b.i.d.
干预措施: Edoxaban (DU-176b) (Drug)
4
DU-176b 60mg tablets two times a day
干预措施: Edoxaban (DU-176b) (Drug)
5
warfarin tablets
干预措施: warfarin (Drug)
结局指标
主要结局
Adjudicated Incidence of Bleeding Events
时间窗: 3 months
Adjudicated Incidence of Bleeding Events during treatment period
Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)
时间窗: 3 months
liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities
次要结局
- Incidence of Major Adverse Cardiac Events MACE)(3 months)
- Effects on Biomarker D-dimer(3 months)
- Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b(3 months)
- Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b(Day 28)
- Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b(Day 28)
- Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b(Day 28)
- Effects on Biomarker Prothrombin Fragments(3 months)
- Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b(3 months)
- Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b(Day 28)
- Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b(Day 28)