Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
Completed · Phase 2
Conditions studied: Ascites, Liver Cirrhosis
In brief
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).
Key facts
- Study ID
- NCT00501722
- Run by
- Sanofi
- People needed
- 110
- Starts
- 2004-04-01
- Expected to finish
- 2005-03-01
- Last updated by the study team
- 2009-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
- Sanofi-Aventis Administrative Office — Cove, New South Wales, Australia
- Sanofi-Aventis Administrative Office — Diegem, Belgium
- Sanofi-Aventis Administrative Office — Laval, Quebec, Canada
- Sanofi-Aventis Administrative Office — Zagreb, Croatia
- Sanofi-Aventis Administrative Office — Prague, Czechia
- 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 — Bucharest, Romania
- Sanofi-Aventis Administrative Office — Barcelona, Spain
Full record on ClinicalTrials.gov
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