Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites (Normo~CAT)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Liver Cirrhosis; Ascites

Treatments: Drug: satavaptan (SR121463B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00501566

SR121463

DFI5563

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind