Satavaptan Dose-Ranging Study in the Prevention of Ascites
Phase 2
Completed
- Conditions
- AscitesLiver Cirrhosis
- Registration Number
- NCT00501384
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.
This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
Inclusion Criteria
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
- Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
- Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months
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 Time to repeat therapeutic paracentesis 12 weeks
- Secondary Outcome Measures
Name Time Method Increase in ascites judged by body weight and ascites volume within 12 weeks frequency of paracentesis 12 weeks quality of life 12 weeks
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇳Taipei, Taiwan