Conditions: Cardiac Edema
Keywords: Vasopressin antagonist , Cardiac Edema ,Diuretics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

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 description:

Arms:
arm 1: None

Interventions: intervention 1: OPC-41061 （Tolvaptan)
Intervention descriptions: intervention 1: 15-30mg/day,daily for 14days

Protocol document: