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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ascites, Liver Cirrhosis

In brief

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).

Key facts

Study ID

NCT00358878

Run by

Sanofi

People needed

463

Starts

2006-07-01

Expected to finish

2008-12-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Cove, New South Wales, Australia
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Quebec, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Zagreb, Croatia
• Sanofi-Aventis Administrative Office — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Porto Salvo, Portugal
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Madrid, Spain
• Sanofi-Aventis Administrative Office — Bromma, Sweden
• Sanofi-Aventis Administrative Office — Guildford, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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