Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: 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 when used concomitantly with a standard dose regimen of spironolactone and furosemide.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

Inclusion Criteria:

• Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
• Moderate or tense ascites
• Serum sodium 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.