Conditions: Cardiac Edema
Keywords: Vasopressin antagonist Cardiac Edema Diuretics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

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 description:

Arms:
arm 1: OPC-41061 arm 2: placebo

Interventions: intervention 1: OPC-41061(Tolvaptan) intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days. intervention 2: Subjects will be orally administered placebo once daily after breakfast for seven days.

Protocol document: