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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00501722 |
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).
Condition | Intervention | Phase |
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Ascites Liver Cirrhosis |
Drug: satavaptan (SR121463B) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study |
Enrollment: | 110 |
Study Start Date: | April 2004 |
Study Completion Date: | March 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Argentina | |
Sanofi-Aventis Administrative Office | |
Buenos Aires, Argentina | |
Australia, New South Wales | |
Sanofi-Aventis Administrative Office | |
Cove, New South Wales, Australia | |
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Canada, Quebec | |
Sanofi-Aventis Administrative Office | |
Laval, Quebec, Canada | |
Croatia | |
Sanofi-Aventis Administrative Office | |
Zagreb, Croatia | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Hungary | |
Sanofi-Aventis Administrative Office | |
Budapest, Hungary | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milano, Italy | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DFI4521, LTS5634, LTS10209 |
Study First Received: | July 13, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00501722 |
Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines; Romania: National Medicines Agency; Croatia: Ministry of Health and Social Care |
cirrhotic ascites hyponatraemia |
Liver Diseases Digestive System Diseases Fibrosis |
Ascites Hyponatremia Liver Cirrhosis |
Pathologic Processes |