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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
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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.
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Secondary ID [1]
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EUDRACT: 2006-000132-27
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Secondary ID [2]
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EFC4493
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Universal Trial Number (UTN)
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Trial acronym
SPARe-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ascites
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Liver Cirrhosis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number and time of recurrences of therapeutic paracenteses
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Assessment method [1]
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Timepoint [1]
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up to 12 weeks
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Secondary outcome [1]
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Time from randomisation to first recurrence of ascites
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Assessment method [1]
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Timepoint [1]
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study period
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Secondary outcome [2]
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Increase in ascites
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Assessment method [2]
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Timepoint [2]
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over 12 weeks
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
501
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Administrative Office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Pennsylvania
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Argentina
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State/province [2]
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San Isidro
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Belgium
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Diegem
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Bosnia and Herzegovina
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Sarajevo
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Bulgaria
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Sofia
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Canada
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Laval
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Croatia
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Zagreb
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Czech Republic
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Praha
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France
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Paris
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Germany
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Berlin
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Hungary
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Budapest
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Israel
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Natanya
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Italy
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Milano
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Portugal
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Porto Salvo
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Romania
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Bucuresti
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Serbia
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Belgrade
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Singapore
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Singapore
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South Africa
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Midrand
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Spain
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Barcelona
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Taiwan
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Taipei
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Country [23]
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United Kingdom
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State/province [23]
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Guildford Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00359437
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ICD CSD
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00359437
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