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

NCT00479336 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2014-03-14

Study results available
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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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · Division of New Product Evalution and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479336 on ClinicalTrials.gov