Clinical Trial: A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

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

Official Title: A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)

Brief Summary: To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.

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

Current Primary Outcome: Body Weight (Amount of Change) [ Time Frame: baseline, Day 7 or at the time of final trial drug administration ]

Change in body weight from baseline at the time of final trial drug administration


Original Primary Outcome: Body Weight (Amount of Change)

Current Secondary Outcome: Body Weight (Percent Change) [ Time Frame: baseline, Day 7 or at the time of final trial drug administration ]

Percent change in body weight from baseline at the time of final trial drug administration


Original Secondary Outcome:

  • Body weight (rate of change)
  • Lower limb edema, pulmonary congestion, other edema, jugular venous distention, hepatomegaly, pulmonary rales, third heart sound, cardiothoracic ratio
  • Echocardiography [Transmitral flow (TMF) E-wave /A-wave velocity ratio, TMF E-wave deceleration time, pulmonary venous flow (PVF) S-wave velocity and D-wave deceleration time, and difference between PVF A-wave duration and TMF A-wave duration (TPA-TMA)]


Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: April 17, 2007
Date Started: April 2007
Date Completion:
Last Updated: December 24, 2013
Last Verified: December 2013