Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites (Normo~CAT)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00501566
First received: July 13, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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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 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.
| 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 Primary Purpose: Treatment |
| Official Title: | SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: 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 [ Time Frame: within 14 days ]
Secondary Outcome Measures:
- Abdominal girth and discomfort [ Time Frame: 14 days ]
- Paracentesis [ Time Frame: 14 days ]
- Quality of life [ Time Frame: 14 days ]
| Enrollment: | 148 |
| Study Start Date: | April 2004 |
| Study Completion Date: | January 2005 |
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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501566
Locations
| 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 | |
| Milan, Italy | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
Sponsors and Collaborators
Sanofi
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00501566 History of Changes |
| Other Study ID Numbers: | DFI5563, SR121463 |
| Study First Received: | July 13, 2007 |
| Last Updated: | July 13, 2007 |
| Health Authority: | Spain: Spanish Agency of Medicines Romania: National Medicines Agency Croatia: Ministry of Health and Social Care United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
cirrhotic ascites |
Additional relevant MeSH terms:
|
Ascites Liver Cirrhosis Fibrosis |
Pathologic Processes Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013