Conditions: Cirrhosis
Keywords: OPC-41061 Tolvaptan ascites Cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite taking conventional diuretics.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: OPC-41061 7.5mg intervention 2: OPC-41061 placebo intervention 3: OPC-41061 15mg intervention 4: OPC-41601 30mg
Intervention descriptions: intervention 1: 7.5mg, 1 tablet a day intervention 2: placebo, 1 tablet a day intervention 3: 15mg, 1 tablet a day intervention 4: 30mg, 1 tablet a day

Protocol document: