Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Inclusion Criteria:

• Participants with cirrhosis of the liver
• Participants with clinically evident ascites primarily managed by diet and/or diuretics
• Stable treatment of ascites for at least the previous 2 weeks without paracentesis
• Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

• Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
• Known hepatocellular carcinoma
• Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
• Participants previously exposed to satavaptan in the past 12 months