Status:
TERMINATED
Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
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 diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs...
Eligibility Criteria
Inclusion
- 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.
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 :
October 1 2008
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00359437
Start Date
July 1 2006
End Date
October 1 2008
Last Update
May 24 2016
Active Locations (24)
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1
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
2
Sanofi-Aventis Administrative Office
San Isidro, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Diegem, Belgium