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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00358878

Collaborator

(none)

463

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Ascites Liver Cirrhosis	Drug: Satavaptan Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

463 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Satavaptan	Drug: Satavaptan oral administration once daily Other Names: SR121463B
Placebo Comparator: Placebo	Drug: placebo oral administration once daily

Arm

Intervention/Treatment

Experimental: Satavaptan

Drug: Satavaptan

oral administration once daily

Other Names:

SR121463B

Placebo Comparator: Placebo

Drug: placebo

oral administration once daily

Outcome Measures

Primary Outcome Measures

Composite endpoint of ascites worsening [at week 12]

Secondary Outcome Measures

Composite endpoint of ascites worsening [at week 24]
Increase in ascites [at week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Buenos Aires		Argentina
3	Sanofi-Aventis Administrative Office	Cove	New South Wales	Australia
4	Sanofi-Aventis Administrative Office	Diegem		Belgium
5	Sanofi-Aventis Administrative Office	Sao Paulo		Brazil
6	Sanofi-Aventis Administrative Office	Laval	Quebec	Canada
7	Sanofi-Aventis Administrative Office	Santiago		Chile
8	Sanofi-Aventis Administrative Office	Zagreb		Croatia
9	Sanofi-Aventis Administrative Office	Horsholm		Denmark
10	Sanofi-Aventis Administrative Office	Paris		France
11	Sanofi-Aventis Administrative Office	Budapest		Hungary
12	Sanofi-Aventis Administrative Office	Natanya		Israel
13	Sanofi-Aventis Administrative Office	Milano		Italy
14	Sanofi-Aventis Administrative Office	Gouda		Netherlands
15	Sanofi-Aventis Administrative Office	Warszawa		Poland
16	Sanofi-Aventis Administrative Office	Porto Salvo		Portugal
17	Sanofi-Aventis Administrative Office	Bucuresti		Romania
18	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
19	Sanofi-Aventis Administrative Office	Madrid		Spain
20	Sanofi-Aventis Administrative Office	Bromma		Sweden
21	Sanofi-Aventis Administrative Office	Guildford	Surrey	United Kingdom