Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Satavaptan

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.