Conditions: Cirrhosis
Keywords: Cirrhosis ascites Tolvaptan OPC-41061
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.

Detailed description:

Arms:
arm 1: Once-daily oral administration of OPC-41061 arm 2: Once-daily oral administration of OPC-41061

Interventions: intervention 1: OPC-41061 intervention 2: OPC-41061
Intervention descriptions: intervention 1: Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days intervention 2: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days

Protocol document: