Satavaptan Dose-Ranging Study in the Prevention of Ascites

Condition(s) targeted: Ascites; Liver Cirrhosis

Intervention: satavaptan (SR121463B) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi-Aventis

The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

Official title: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Time to repeat therapeutic paracentesis

Secondary outcome:

Increase in ascites judged by body weight and ascites volume

frequency of paracentesis

quality of life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical

evidence

- Patients having undergone therapeutic paracentesis for the removal of ascites in the

previous 24 hours with the removal of ≥4 L of fluid

- Patients having undergone at least 1 other therapeutic paracentesis in the previous 3

months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Sanofi-Aventis Administrative Office, Diegem, Belgium

Sanofi-Aventis Administrative Office, Zagreb, Croatia

Sanofi-Aventis Administrative Office, Praha, Czech Republic

Sanofi-Aventis Administrative Office, Paris, France

Sanofi-Aventis Administrative Office, Berlin, Germany

Sanofi-Aventis Administrative Office, Milano, Italy

Sanofi-Aventis Administrative Office, Barcelona, Spain

Sanofi-Aventis Administrative Office, Taipei, Taiwan

Sanofi-Aventis Administrative Office, Cove, New South Wales, Australia

Sanofi-Aventis Administrative Office, Laval, Quebec, Canada

Starting date: April 2004
Ending date: May 2005
Last updated: October 17, 2007