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

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.

Timeline

Start

2007-06

Primary completion

2009-01

Completion

2009-01

Drugs

Indications