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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358878
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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 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).


Condition or disease Intervention/treatment Phase
Ascites Liver Cirrhosis Drug: Satavaptan Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
Study Start Date : July 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Satavaptan Drug: Satavaptan
oral administration once daily
Other Name: SR121463B
Placebo Comparator: Placebo Drug: placebo
oral administration once daily


Outcome Measures
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Primary Outcome Measures :
  1. Composite endpoint of ascites worsening [ Time Frame: at week 12 ]

Secondary Outcome Measures :
  1. Composite endpoint of ascites worsening [ Time Frame: at week 24 ]
  2. Increase in ascites [ Time Frame: at week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358878


Locations
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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada, Quebec
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
France
Sanofi-Aventis Administrative Office
Paris, France
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Spain
Sanofi-Aventis Administrative Office
Madrid, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00358878    
Other Study ID Numbers: EFC4492
EudraCT : 2006-000132-27
LTS10036
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Ascites
Liver Cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Satavaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs