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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/NCT00501722




Registration number
NCT00501722
Ethics application status
Date submitted
13/07/2007
Date registered
16/07/2007
Date last updated
12/01/2009

Titles & IDs
Public title
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
Scientific title
SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
Secondary ID [1] 0 0
LTS5634
Secondary ID [2] 0 0
DFI4521
Universal Trial Number (UTN)
Trial acronym
Hypo~CAT
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - satavaptan (SR121463B)

Treatment: Drugs: satavaptan (SR121463B)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
change in body weight, change in serum sodium
Timepoint [1] 0 0
within 14 days
Secondary outcome [1] 0 0
abdominal girth and discomfort
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
paracentesis
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
trail-making test and quality of life
Timepoint [3] 0 0
14 days

Eligibility
Key inclusion criteria
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical
evidence

- Moderate or tense ascites

- Patients with hyponatremia, defined as a serum sodium concentration of =130 mmol/L

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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 2
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
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2005
Sample size
Target
Accrual to date
Final
110
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
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Croatia
State/province [5] 0 0
Zagreb
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Romania
State/province [11] 0 0
Bucuresti
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the
treatment of ascites and the correction of hyponatraemia when used concomitantly with a
standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of
SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term
safety extension (Expo~CAT). The first extension is followed by another long-term study
(PASCCAL-1).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00501722
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/NCT00501722