A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)|
- Pharmacological Outcome Variables(Urine volume, fluid intake, urine osmolality, quantitative examination,biochemical examination of blood, plasma AVP) [ Time Frame: after 7days treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
Placebo Comparator: 2
Subjects will be orally administered placebo once daily after breakfast for seven days.