A dose-defining study of OPC-41061 in treatment of hepatic edema

Otsuka Pharmaceutical Co., Ltd.0 个研究点开始时间: 2007年5月21日最近更新: 2023年10月17日

试验速览

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•(1)Subjects with ascites despite taking either of the following combinations of loop diuretics and an anti-aldosterone agent (spironolactone) for at least 7 days prior to start of the study drug administration.
•Combination 1: Loop diuretics at indicated below in combination with an anti-aldosterone agent at a daily dose of 25 mg or more
•- Furosemide: 40 mg/day or more
•- Other loop diuretic: a daily dosage equivalent to 40 mg or more of furosemide (Bumetanide: 1 mg/day or more, Piretanide: 6 mg/day or more, Azosemide: 60 mg/day or more,Torasemide: 8mg/day or more)
•Combination 2: Anti-aldosterone agent at a daily dose of 50 mg or more in combination with furosemide at a daily dose of 20 mg or more (or one of the other loop diuretics specified in Combination 1 at a daily dosage equivalent to 20 mg or more of furosemide)
•(2) Patients who have been hospitalized or are able to stay at the study site from the start of the run-in observation period until completion of postdosing observation 2.
•(3) Male or females subjects of age 20 or above and below the age of 80 (at time of informed consent).
•(4) Subjects capable of giving informed consent to participate in the study of their own free will.

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