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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00358878

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 III

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	440
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: satavaptan (SR121463B) oral administration once daily
2: Placebo Comparator	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-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD )
Study ID Numbers:	EFC4492, EudraCT : 2006-000132-27, LTS10036
Study First Received:	July 31, 2006
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00358878
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Ascites
Liver Cirrhosis

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis
Ascites
Liver Cirrhosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009