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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