Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites

SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study

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).

Inclusion Criteria:

• Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence
• Moderate or tense ascites
• Patients with hyponatremia, defined as a serum sodium concentration 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.