Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
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).