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临床试验/JPRN-jRCT2080220391
JPRN-jRCT2080220391未知3 期

A double-blind, placebo-controlled study of OPC-41061 in the treatment of cardiac edema (congestive heart failure)

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

试验速览

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 scheduled to start treatment during the run-in observation period
  • 1) A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
  • 2) Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
  • 3) Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
  • (2) 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.
  • (3) Male or female subjects age 20 or older and younger than 85 (at time of informed consent)
  • (4) Subjects who are able to stay at the study site from the day before the start of the run-in observation period until completion of postdosing examination 2 (7 to 10 days after final study drug administration)
  • (5) 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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