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

To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in patients with cirrhosis of the liver and to evaluate the tolerability and safety of satavaptan over a 52-week treatment period in patients with cirrhosis of the liver and ascites.

Official Title

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

Conditions

Ascites, Liver Cirrhosis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Composite endpoint of ascites worsening at week 12

Secondary Outcome Measures:

• Composite endpoint of ascites worsening at week 24. Increase in ascites at week 12

Study Start

July 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

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

Exclusion Criteria:

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

Total Enrolment

440

Contact Details

Cove, New South Wales, Australia; Recruiting

• GV-Contact-us@sanofi-aventis.com