Satavaptan Dose-Ranging Study in the Prevention of Ascites

Liver Cirrhosis Clinical Trial

— SPA  

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 Details — Status: Completed

Administrative data

• NCT number: NCT00501384
• Other study ID #: DFI4522
• Secondary ID: LTS5635LTS10209
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2007
• Last updated: January 9, 2009
• Start date: April 2004
• Est. completion date: May 2005

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaSpain: Spanish Agency of MedicinesItaly: Ministry of Health
• Study type: Interventional

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Intervention

Drug:
• satavaptan (SR121463B)

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Cove	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval	Quebec
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
Spain	Sanofi-Aventis Administrative Office	Barcelona
Taiwan	Sanofi-Aventis Administrative Office	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Canada,  Croatia,  Czech Republic,  France,  Germany,  Italy,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to repeat therapeutic paracentesis		12 weeks
Secondary	Increase in ascites judged by body weight and ascites volume		within 12 weeks
Secondary	frequency of paracentesis		12 weeks
Secondary	quality of life		12 weeks

External Links

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