Status:
COMPLETED
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
Lead Sponsor:
Sanofi
Conditions:
Ascites
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00358878
Start Date
July 1 2006
End Date
December 1 2008
Last Update
May 26 2016
Active Locations (21)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
4
Sanofi-Aventis Administrative Office
Diegem, Belgium