Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites (Hypo~CAT)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00501722
First received: July 13, 2007
Last updated: January 9, 2009
Last verified: January 2009
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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 2 |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
Cirrhosis
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- change in body weight, change in serum sodium [ Time Frame: within 14 days ]
Secondary Outcome Measures:
- abdominal girth and discomfort [ Time Frame: 14 days ]
- paracentesis [ Time Frame: 14 days ]
- trail-making test and quality of life [ Time Frame: 14 days ]
| 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 |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501722
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 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Sanofi:
|
cirrhotic ascites hyponatraemia |
Additional relevant MeSH terms:
|
Ascites Hyponatremia Liver Cirrhosis Fibrosis Pathologic Processes |
Water-Electrolyte Imbalance Metabolic Diseases Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013