Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites

Liver Cirrhosis Clinical Trial

— Hypo~CAT  

Official title:

SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501722
• Other study ID #: DFI4521
• Secondary ID: LTS5634LTS10209
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2007
• Last updated: January 9, 2009
• Start date: April 2004
• Est. completion date: March 2005

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of MedicinesRomania: National Medicines AgencyCroatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical Trial Summary

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2005
• Est. primary completion date: March 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

• Moderate or tense ascites

• Patients with hyponatremia, defined as a serum sodium concentration 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.

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
Hungary	Sanofi-Aventis Administrative Office	Budapest
Italy	Sanofi-Aventis Administrative Office	Milano
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Spain	Sanofi-Aventis Administrative Office	Barcelona
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Croatia,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight, change in serum sodium		within 14 days
Secondary	abdominal girth and discomfort		14 days
Secondary	paracentesis		14 days
Secondary	trail-making test and quality of life		14 days

External Links

•   Link