Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00358878




Registration number
NCT00358878
Ethics application status
Date submitted
31/07/2006
Date registered
1/08/2006
Date last updated
26/05/2016

Titles & IDs
Public title
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
Scientific 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
Secondary ID [1] 0 0
EudraCT : 2006-000132-27
Secondary ID [2] 0 0
EFC4492
Universal Trial Number (UTN)
Trial acronym
CATS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ascites 0 0
Liver Cirrhosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Satavaptan
Treatment: Drugs - placebo

Experimental: Satavaptan -

Placebo comparator: Placebo -


Treatment: Drugs: Satavaptan
oral administration once daily

Treatment: Drugs: placebo
oral administration once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite endpoint of ascites worsening
Timepoint [1] 0 0
at week 12
Secondary outcome [1] 0 0
Composite endpoint of ascites worsening
Timepoint [1] 0 0
at week 24
Secondary outcome [2] 0 0
Increase in ascites
Timepoint [2] 0 0
at week 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
463
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago
Country [7] 0 0
Croatia
State/province [7] 0 0
Zagreb
Country [8] 0 0
Denmark
State/province [8] 0 0
Horsholm
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Hungary
State/province [10] 0 0
Budapest
Country [11] 0 0
Israel
State/province [11] 0 0
Natanya
Country [12] 0 0
Italy
State/province [12] 0 0
Milano
Country [13] 0 0
Netherlands
State/province [13] 0 0
Gouda
Country [14] 0 0
Poland
State/province [14] 0 0
Warszawa
Country [15] 0 0
Portugal
State/province [15] 0 0
Porto Salvo
Country [16] 0 0
Romania
State/province [16] 0 0
Bucuresti
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Moscow
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Sweden
State/province [19] 0 0
Bromma
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00358878
Trial related presentations / publications
Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.
Public notes

Contacts
Principal investigator
Name 0 0
ICD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00358878