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Satavaptan Dose-Ranging Study in the Prevention of Ascites — SPA  

Liver Cirrhosis Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00501384
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date April 2004
Completion date May 2005
View Details
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