A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group, Non-inferiority Trial to Evaluate the Efficacy and Safety of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight
研究概览
简要总结
To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are currently on treatment with any of the following diuretics
- •Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
- •Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
- •Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
- •Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- •Patients who are currently hospitalized or who are able to be hospitalized during the trial
排除标准
- •Patients with acute heart failure
- •Patients who are on a ventricular assist device
- •Patients who are unable to sense thirst or who have difficulty with fluid intake
研究组 & 干预措施
OPC-61815 injection 16 mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg
干预措施: OPC-61815 (Drug)
Tolvaptan tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo
干预措施: Tolvaptan Tab 15 MG (Drug)
结局指标
主要结局
Change From Baseline in Body Weight
时间窗: Baseline, Day 6
Change in body weight from baseline (before investigational medicinal product \[IMP\] administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Jugular Venous Distension and Hepatomegaly(Baseline, Day 6)
- Improvement Rate for Lower Limb Edema and Pulmonary Congestion(Baseline, Day 6)
- Percentage of Subjects Who Achieve Resolution of Pulmonary Rales and Third Cardiac Sound(Baseline, Day 6)
- Improvement Rate for New York Heart Association (NYHA) Classification(Baseline, Day 6)