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

Liver Cirrhosis Clinical Trial

— CATS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358878
• Other study ID #: EFC4492
• Secondary ID: EudraCT : 2006-0
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2006
• Last updated: July 17, 2009
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Intervention

Drug:
• satavaptan (SR121463B)
oral administration once daily
• placebo
oral administration once daily

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Cove	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval	Quebec
Chile	Sanofi-Aventis Administrative Office	Santiago
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Denmark	Sanofi-Aventis Administrative Office	Horsholm
France	Sanofi-Aventis Administrative Office	Paris
Hungary	Sanofi-Aventis Administrative Office	Budapest
Israel	Sanofi-Aventis Administrative Office	Natanya
Italy	Sanofi-Aventis Administrative Office	Milano
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Spain	Sanofi-Aventis Administrative Office	Madrid
Sweden	Sanofi-Aventis Administrative Office	Bromma
United Kingdom	Sanofi-Aventis Administrative Office	Guildford	Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Croatia,  Denmark,  France,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of ascites worsening		at week 12	No
Secondary	Composite endpoint of ascites worsening		at week 24	No
Secondary	Increase in ascites		at week 12	No