JPRN-jRCT2080220442未知3 期
A clinical phamacological study of OPC-41061 in the treatment of cardiac edema (congestive heart failure)
适应症
试验速览
- 阶段
- 3 期
研究概览
简要总结
暂无简介。
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 receiving one of the following diuretic treatments (including Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
- •2) Subjects able to receive a daily fixed dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
- •3) CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion (Patients with pulmonary congestion can be enrolled if pulmonary congestion is confirmed on chest x-ray taken within 14 days prior to the screening examination.)
- •4) Male or female subjects between the age of 20 and 85, inclusive (at time of informed consent)
- •5) Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination 2 (7 to 10 days after final study drug administration)
- •6) Subjects capable of giving informed consent to participate in the study of their own free will
排除标准
- 未提供
研究者
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