JPRN-jRCT2080224173已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 294
研究概览
简要总结
The noninferiority of OPC-61815 16 mg to tolvaptan 15 mg was confirmed using the change in body weight after administration of OPC-61815 16 mg or tolvaptan 15 mg once daily for 5 days as the primary endpoint. - No safety concerns were observed. The overall incidence of TEAEs was similar in both the OPC-61815 16 mg treatment group and the tolvaptan 15 mg treatment group.
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. 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
- •2. Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- •3. Patients who are currently hospitalized or who are able to be hospitalized during the trial
排除标准
- •1. Patients with acute heart failure
- •2. Patients who are on a ventricular assist device
- •3. Patients who are unable to sense thirst or who have difficulty with fluid intake
研究者
相似试验
已完成
3 期
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailureCongestive Heart FailureNCT03772041Otsuka Pharmaceutical Co., Ltd.294
已完成
不适用
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailureCongestive Heart FailureNCT03254108Otsuka Pharmaceutical Co., Ltd.61
已完成
4 期
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure PatientsHeart FailureNCT01439009Otsuka Pharmaceutical Co., Ltd.100
撤回
3 期
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic HyponatremiaHyponatremiaNCT02442674Otsuka Pharmaceutical Development & Commercialization, Inc.
终止
3 期
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic HyponatremiaHyponatremiaNCT02012959Otsuka Pharmaceutical Development & Commercialization, Inc.9