Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

Phase 2

Completed

• Conditions: Liver Cirrhosis; Ascites

• Registration Number: NCT00501566
• 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 when used concomitantly with a standard dose regimen of spironolactone and furosemide.

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

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
• Moderate or tense ascites
• Serum sodium 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	within 14 days

Secondary Outcome Measures

Name	Time	Method
Paracentesis	14 days
Quality of life	14 days
Abdominal girth and discomfort	14 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain