Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
NCT ID: NCT00359437
Last Updated: 2016-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
501 participants
INTERVENTIONAL
2006-07-31
2008-10-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Satavaptan
Satavaptan
oral administration once daily
Placebo
placebo
oral administration once daily
Interventions
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Satavaptan
oral administration once daily
placebo
oral administration once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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References
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Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.
Other Identifiers
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EUDRACT: 2006-000132-27
Identifier Type: -
Identifier Source: secondary_id
LTS10036
Identifier Type: -
Identifier Source: secondary_id
EFC4493
Identifier Type: -
Identifier Source: org_study_id
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