JPRN-jRCT2080223620已完成2 期
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
研究概览
简要总结
OPC-41061 exposure (Cmax and AUC24h) on Day 1 following single intravenous administration of OPC-61815 at 16 mg was the most similar to that following single administration of tolvaptan 15-mg tablet. There was no marked difference in tolerability between OPC-61815 at 16 mg and tolvaptan 15-mg tablet, and no clinically significant problems were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1. Subjects 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
- •2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- •3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial
排除标准
- •1. Subjects with acute heart failure
- •2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
- •3. Subjects who are unable to sense thirst or who have difficulty with fluid intake
研究者
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