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Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

NCT01349348 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 535

Last updated 2012-10-12

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients with cirrhosis ascites who fail to response adequately to treatment with common diuretics.

Conditions

  • Ascites
  • Hepatic Cirrhosis

Interventions

DRUG

Tolvaptan

tablet, 15 mg, Qd, for 7 days

DRUG

Tolvaptan

tablet, 7.5 mg, Qd, for 7 days

DRUG

placebo

tablet, 7.5/15mg , Qd, 7days.

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Minde Zeng · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT01349348 on ClinicalTrials.gov