Overview

A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Treatments:
Tolvaptan