A Multicenter, Open-label, Uncontrolled Clinical Trial to Confirm the Tolerability of OPC-61815 in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake

Otsuka Pharmaceutical Co., LTD.0 个研究点目标入组 45 人开始时间: 2019年4月16日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Otsuka Pharmaceutical Co., LTD.
入组人数: 45

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

There was no unacceptable safety issues at the starting dose of 8 mg nor were there any marked differences in tolerability between subjects who maintained the dose at 8 mg or who increased dose to 16 mg. 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. Patients receiving loop diuretic injection at a dose equivalent to furosemide 20 mg/day or higher
•2. CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
•3. Patients who are judged by the investigator or subinvestigator to have difficulty or be incapable of oral intake, including patients who are judged by the investigator or subinvestigator to require nothing by mouth(NPO) management
•4. Patients who are currently hospitalized or who are capable of being hospitalized from the time of informed consent until the end of the treatment period
•5. Patients who are capable of giving informed consent

排除标准

•1. Patients who are on a ventricular assist device
•2. Patients who have difficulty with spontaneous respiration or who have been on tracheal intubation under sedative therapy
•3. Patients with severe disturbed consciousness (ie, coma or stupor)

研究者

发起方

Otsuka Pharmaceutical Co., LTD.

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