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Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

NCT00366795 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2016-05-18

No results posted yet for this study

Summary

Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Conditions

Interventions

DRUG

Satavaptan

oral administration once daily

DRUG

placebo

oral administration once daily

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Malaysia
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00366795 on ClinicalTrials.gov