Clinical Trial: A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Dose Response of OPC-41061 in Congestive Heart Failure Patients With Extracellular Volume Expansion

Brief Summary: This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: Body Weight [ Time Frame: Baseline, at the time of final trial drug administration ]

Original Primary Outcome: Body Weight

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: October 4, 2005
Date Started: August 2004
Date Completion:
Last Updated: November 6, 2013
Last Verified: November 2013