Satavaptan Dose-Ranging Study in the Prevention of Ascites
Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
Participant gender:
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).