NCT00479336

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	OPC-41061 7.5mg	7.5mg, 1 tablet a day
DRUG	OPC-41061 placebo	placebo, 1 tablet a day
DRUG	OPC-41061 15mg	15mg, 1 tablet a day
DRUG	OPC-41601 30mg	30mg, 1 tablet a day

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-05-28
• Last updated: 2014-03-14
• Results posted: 2014-03-14

Locations

7 sites across 1 country: Japan