Conditions: Cirrhosis
Keywords: Cirrhosis ascites Tolvaptan OPC-41061
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at the time of the final administration will be compared between the two groups.

Detailed description:

Arms:
arm 1: None arm 2: None

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

Protocol document: