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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00358878
First received: July 31, 2006
Last updated: July 17, 2009
Last verified: July 2009
  Purpose

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in patients with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in patients 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 Intervention Phase
Ascites
Liver Cirrhosis
Drug: satavaptan (SR121463B)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Composite endpoint of ascites worsening [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite endpoint of ascites worsening [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Increase in ascites [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Enrollment: 463
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: satavaptan (SR121463B)
oral administration once daily
Placebo Comparator: 2 Drug: placebo
oral administration once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cirrhosis of the liver
  • Patients with clinically evident ascites primarily managed by diet and/or diuretics
  • Stable treatment of ascites for at least the previous 2 weeks without paracentesis
  • Patients having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

  • Patients with an existing functional TIPS (transjugular intrahepatic portosystemic shunt) or other shunt
  • Known hepatocellular carcinoma
  • Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
  • Patients previously exposed to satavaptan in the past 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358878

  Show 21 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00358878     History of Changes
Other Study ID Numbers: EFC4492, EudraCT : 2006-000132-27, LTS10036
Study First Received: July 31, 2006
Last Updated: July 17, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Ascites
Liver Cirrhosis

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014