Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ascites; Liver Cirrhosis
Intervention: satavaptan (SR121463B) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi-Aventis
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).
Clinical Details
Official title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: change in body weight, change in serum sodium
Secondary outcome: abdominal girth and discomfortparacentesis trail-making test and quality of life
Eligibility
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
- 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.
Locations and Contacts
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, Budapest, Hungary
Sanofi-Aventis Administrative Office, Milano, Italy
Sanofi-Aventis Administrative Office, Bucuresti, Romania
Sanofi-Aventis Administrative Office, Barcelona, Spain
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States
Sanofi-Aventis Administrative Office, Cove, New South Wales, Australia
Sanofi-Aventis Administrative Office, Laval, Quebec, Canada
Additional Information
Starting date: April 2004
Ending date: March 2005
Last updated: October 17, 2007
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