Clinical Trial: A Clinical Pharmacological 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 Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
Brief Summary: To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.
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: Pharmacological Outcome Variables(Urine volume, fluid intake, urine osmolality, quantitative examination,biochemical examination of blood, plasma AVP) [ Time Frame: after 7days treatment ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Otsuka Pharmaceutical Co., Ltd.
Dates:
Date Received: September 3, 2007
Date Started: September 2007
Date Completion:
Last Updated: November 6, 2013
Last Verified: November 2013