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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
研究概览
简要总结
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 receiving loop diuretic injection at a dose equivalent to furosemide 20 mg/day or higher
- •CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- •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
- •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
- •Patients who are capable of giving informed consent
排除标准
- •Patients who are on a ventricular assist device
- •Patients who have difficulty with spontaneous respiration or who have been on tracheal intubation under sedative therapy
- •Patients with severe disturbed consciousness (ie, coma or stupor)
研究组 & 干预措施
OPC-61815 injection
Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
干预措施: OPC-61815 injection (Drug)
结局指标
主要结局
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
时间窗: From the start of IMP administration (Day 1) up to 15 days
"An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an AE that leads to death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient or prolonged hospitalization, results in a congenital anomaly/birth defect, or any other important medical event which is medically significant. A TEAE is an AE that occurs only after a subject has received IMP.
次要结局
- Change From Baseline in Body Weight(Baseline, Day after final IMP administration)
- Improvement Rate for Lower Limb Edema(Baseline, Day after final IMP administration)
- Improvement Rate for Pulmonary Congestion(Baseline, Day after final IMP administration)