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

Cirrhosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01050530
Study type Interventional
Source Otsuka Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date December 2009
Completion date February 2012
View Details
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