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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00359437




Registration number
NCT00359437
Ethics application status
Date submitted
1/08/2006
Date registered
2/08/2006
Date last updated
24/05/2016

Titles & IDs
Public title
Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
Scientific title
Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Secondary ID [1] 0 0
EUDRACT: 2006-000132-27
Secondary ID [2] 0 0
EFC4493
Universal Trial Number (UTN)
Trial acronym
SPARe-1
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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
Number and time of recurrences of therapeutic paracenteses
Timepoint [1] 0 0
up to 12 weeks
Secondary outcome [1] 0 0
Time from randomisation to first recurrence of ascites
Timepoint [1] 0 0
study period
Secondary outcome [2] 0 0
Increase in ascites
Timepoint [2] 0 0
over 12 weeks

Eligibility
Key inclusion criteria
- Participants with cirrhosis of the liver.

- Participants with recurrent ascites having undergone both of the following:

- therapeutic paracentesis for the removal of ascites in the previous 24 hours with
the removal of > 4 litres of fluid.

- at least one other therapeutic paracentesis in the previous 3 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
Terminated
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
1/10/2008
Sample size
Target
Accrual to date
Final
501
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Argentina
State/province [2] 0 0
San Isidro
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Bosnia and Herzegovina
State/province [4] 0 0
Sarajevo
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Croatia
State/province [7] 0 0
Zagreb
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Israel
State/province [12] 0 0
Natanya
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Malaysia
State/province [15] 0 0
Kuala Lumpur
Country [16] 0 0
Portugal
State/province [16] 0 0
Porto Salvo
Country [17] 0 0
Romania
State/province [17] 0 0
Bucuresti
Country [18] 0 0
Serbia
State/province [18] 0 0
Belgrade
Country [19] 0 0
Singapore
State/province [19] 0 0
Singapore
Country [20] 0 0
South Africa
State/province [20] 0 0
Midrand
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Guildford 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 diuretic drugs in reducing the
recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over
a 52-week treatment period in participants with cirrhosis of the liver and recurrent 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/ct2/show/NCT00359437
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
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/ct2/show/NCT00359437