NCT01050530

A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	OPC-41061	Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
DRUG	Placebo	Once-daily oral administration of placebo after breakfast for 7 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-01-15
• Last updated: 2014-03-04
• Results posted: 2014-01-31

Locations

8 sites across 1 country: Japan