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Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

NCT01349335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-10-12

No results posted yet for this study

Summary

To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.

Conditions

  • Ascites
  • Hepatic Cirrhosis

Interventions

DRUG

Tolvaptan

tablet, 15 mg, Qd, for 7 days

DRUG

Tolvaptan

tablet, 30 mg, Qd, 7 days

DRUG

placebo

tablet, 30 mg, 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
2009-04-30
Primary Completion
2010-01-31
Completion
2010-04-30

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 NCT01349335 on ClinicalTrials.gov