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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00501722 |
Purpose
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 |
|---|---|---|
|
Ascites Liver Cirrhosis |
Drug: satavaptan (SR121463B) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Eligibility| 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.
Contacts and Locations| 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 |
More Information
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00501722 History of Changes |
| Other Study ID Numbers: | DFI4521, LTS5634, LTS10209 |
| Study First Received: | July 13, 2007 |
| Last Updated: | January 9, 2009 |
| 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 |
|
Ascites Hyponatremia Liver Cirrhosis Fibrosis Pathologic Processes |
Water-Electrolyte Imbalance Metabolic Diseases Liver Diseases Digestive System Diseases |
