Clinical Trial: A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)

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

Official Title: Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) — an Investigation of the Safety of Treatment Beyond 7 Days

Brief Summary: To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.

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

Current Primary Outcome: Body Weight [ Time Frame: Baseline, Day 14 or at the time of final drug administration ]

The change of body weight from baseline at final observation


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: October 15, 2007
Date Started: October 2007
Date Completion:
Last Updated: December 24, 2013
Last Verified: December 2013