Conditions: Heart Failure, Congestive Edema
Keywords: OPC-41061 Tolvaptan Heart Failure Edema Extracellular volume expansion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.

Detailed description:

Arms:

Interventions: intervention 1: OPC-41061(Tolvaptan)
Intervention descriptions: intervention 1: None

Protocol document: