Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ascites, Liver Cirrhosis

In brief

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent 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

NCT00359437

Run by

Sanofi

People needed

501

Starts

2006-07-01

Expected to finish

2008-10-01

Last updated by the study team

2016-05-24

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 recurrent ascites having undergone both of the following:
• therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of > 4 litres of fluid.
• at least one other therapeutic paracentesis in the previous 3 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 — Malvern, Pennsylvania, United States
• Sanofi-Aventis Administrative Office — San Isidro, Argentina
• Sanofi-Aventis Administrative Office — Macquarie Park, Australia
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — Sarajevo, Bosnia and Herzegovina
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Zagreb, Croatia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — Porto Salvo, Portugal
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Belgrade, Serbia
• Sanofi-Aventis Administrative Office — Singapore, Singapore
• Sanofi-Aventis Administrative Office — Midrand, South Africa
• Sanofi-Aventis Administrative Office — Seoul, South Korea
• Sanofi-Aventis Administrative Office — Barcelona, Spain
• Sanofi-Aventis Administrative Office — Taipei, Taiwan
• Sanofi-Aventis Administrative Office — Guildford Surrey, United Kingdom

Full record on ClinicalTrials.gov

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