Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00501566

Acronym

Normo~CAT

Enrollment

148

Registered

2007-07-16

Start date

2004-04-30

Completion date

2005-01-31

Last updated

2007-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Liver Cirrhosis

Keywords

cirrhotic ascites

Brief summary

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

Interventions

DRUGsatavaptan (SR121463B)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence * Moderate or tense ascites * Serum sodium 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	within 14 days

Secondary

Measure	Time frame
Abdominal girth and discomfort	14 days
Paracentesis	14 days
Quality of life	14 days

Countries

Argentina, Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Hungary, Italy, Romania, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026