Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Incidence of Any Adjudicated Bleeding Events
研究概览
简要总结
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).
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
- •Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.
排除标准
- •Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
- •Patients who are at a significantly high risk for bleeding
- •Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
- •Patients who have evidence of hepatic function test abnormalities
研究组 & 干预措施
SRI 15mg
DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.
干预措施: DU-176b 15mg (Drug)
Normal/MiRI low-dose group
DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
干预措施: DU-176b 30mg (Drug)
Normal/MiRI high-dose group
DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
干预措施: DU-176b 60mg (Drug)
结局指标
主要结局
Incidence of Any Adjudicated Bleeding Events
时间窗: 3 months
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)
次要结局
未报告次要终点