Clinical Trial: Satavaptan Dose-Ranging Study in the Prevention of Ascites
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites<
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 Summary:
Sponsor: Sanofi
Current Primary Outcome: Time to repeat therapeutic paracentesis [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Increase in ascites judged by body weight and ascites volume [ Time Frame: within 12 weeks ]
- frequency of paracentesis [ Time Frame: 12 weeks ]
- quality of life [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: July 13, 2007
Date Started: April 2004
Date Completion:
Last Updated: January 9, 2009
Last Verified: January 2009
