Ascites, Liver Cirrhosis
Conditions
Keywords
cirrhotic ascites, hyponatraemia
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).
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in body weight, change in serum sodium | within 14 days |
Secondary
| Measure | Time frame |
|---|---|
| abdominal girth and discomfort | 14 days |
| paracentesis | 14 days |
| trail-making test and quality of life | 14 days |
Countries
Argentina, Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Hungary, Italy, Romania, Spain, United States
Outcome results
None listed