A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8
研究概览
简要总结
To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
- •Subjects undergoing any of the following diuretic therapies
- •Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
- •Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
- •Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
- •Subjects who were currently hospitalized or who are able to be hospitalized
排除标准
- •Subjects with acute heart failure
- •Subjects with an assisted circulation device
- •Subjects who cannot sense thirst or who have difficulty in ingesting water
研究组 & 干预措施
OPC 131461 2mg group
OPC-131461 1 mg tablet ｘ 2
干预措施: OPC 131461 2mg group (Drug)
OPC 131461 10mg group
OPC-131461 5 mg tablet ｘ 2
干预措施: OPC 131461 10mg group (Drug)
OPC 131461 5mg group
OPC-131461 5 mg tablet and placebo tablet
干预措施: OPC 131461 5mg group (Drug)
OPC 131461 1mg group
OPC-131461 1 mg tablet and placebo tablet
干预措施: OPC 131461 1mg group (Drug)
Placebo
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8
时间窗: Baseline, Day 8
Calculate the change in body weight from the baseline up to Day 8 (kg)
次要结局
- Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 15(Baseline, Day15)
- Improvement of or Change in Congestive Findings ( Lower Limb Edema ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7(Baseline, Day7)
- Improvement of or Change in Congestive Findings ( Pulmonary Congestion ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7(Baseline, Day7)