Satavaptan Dose-Ranging Study in Normonatraemic 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 when used concomitantly with a standard dose regimen of spironolactone
and furosemide.
The secondary objective is to determine the tolerability of different fixed doses of
SR121463B over a 14 day treatment period in cirrhotic ascites.
Clinical Details
Official title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in body weight
Secondary outcome: Abdominal girth and discomfortParacentesis 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
- Serum sodium 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, Milan, Italy
Sanofi-Aventis Administrative Office, Bucuresti, Romania
Sanofi-Aventis Administrative Office, Barcelona, Spain
Sanofi-Aventis Administrative Office, Cove, New South Wales, Australia
Sanofi-Aventis Administrative Office, Laval, Quebec, Canada
Additional Information
Starting date: April 2004
Ending date: January 2005
Last updated: July 13, 2007
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