Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites

Phase 2

Completed

• Conditions: Ascites; Liver Cirrhosis

• Registration Number: NCT00501722
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo\~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo\~CAT). The first extension is followed by another long-term study (PASCCAL-1).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-09
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence
• Moderate or tense ascites
• Patients with hyponatremia, defined as a serum sodium concentration of ≤130 mmol/L

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in body weight, change in serum sodium	within 14 days

Secondary Outcome Measures

Name	Time	Method
abdominal girth and discomfort	14 days
paracentesis	14 days
trail-making test and quality of life	14 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain