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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00358878
First received: July 31, 2006
Last updated: April 26, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Ascites Liver Cirrhosis Drug: Satavaptan Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

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 ]

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

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: Satavaptan Drug: Satavaptan
oral administration once daily
Other Name: SR121463B
Placebo Comparator: Placebo Drug: placebo
oral administration once daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
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: April 26, 2016

Keywords provided by Sanofi:
Ascites
Liver Cirrhosis

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases
Satavaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017