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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014