- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00501566
Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites (Normo~CAT)
SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Sanofi-Aventis Administrative Office
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New South Wales
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Cove, New South Wales, Australia
- Sanofi-Aventis Administrative Office
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Diegem, Belgium
- Sanofi-Aventis Administrative Office
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Quebec
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Laval, Quebec, Canada
- Sanofi-Aventis Administrative Office
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Zagreb, Croatia
- Sanofi-Aventis Administrative Office
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Praha, Czech Republic
- Sanofi-Aventis Administrative Office
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Paris, France
- Sanofi-Aventis Administrative Office
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Berlin, Germany
- Sanofi-Aventis Administrative Office
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Budapest, Hungary
- Sanofi-Aventis Administrative Office
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Milan, Italy
- Sanofi-Aventis Administrative Office
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Bucuresti, Romania
- Sanofi-Aventis Administrative Office
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Barcelona, Spain
- Sanofi-Aventis Administrative Office
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in body weight
Time Frame: within 14 days
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within 14 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Abdominal girth and discomfort
Time Frame: 14 days
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14 days
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Paracentesis
Time Frame: 14 days
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14 days
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Quality of life
Time Frame: 14 days
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14 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFI5563
- SR121463
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cirrhosis
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Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
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The Second Affiliated Hospital of Chongqing Medical...RecruitingFibrosis, Liver | Cirrhosis, LiverChina
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SUUMC Central Military Hospital Dr Carol DavilaRecruiting
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The Cleveland ClinicRecruiting
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The Cleveland ClinicRecruitingCirrhosis, LiverUnited States
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University of PittsburghNational Institute on Drug Abuse (NIDA)CompletedCirrhosis, LiverUnited States
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Beth Israel Deaconess Medical CenterAmerican Association for the Study of Liver Diseases FoundationCompleted
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Asian Institute of Gastroenterology, IndiaCompletedCirrhosis, LiverIndia
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Sherief Abd-ElsalamUnknown
Clinical Trials on satavaptan (SR121463B)
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SanofiCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionFrance, Germany, Belgium, Hungary
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SanofiCompletedLiver Cirrhosis | AscitesFrance, Germany, Italy, Spain, Taiwan, Belgium, Czech Republic, Argentina, Croatia, Canada, Australia
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SanofiCompletedLiver Cirrhosis | AscitesUnited States, France, Romania, Germany, Italy, Spain, Belgium, Czech Republic, Argentina, Croatia, Hungary, Canada, Australia
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SanofiTerminatedLiver Cirrhosis | AscitesFrance, Canada, Romania, Australia, Germany, Italy, Portugal, Spain, Bulgaria, Malaysia, Serbia, Singapore, Taiwan, Belgium, Czech Republic, Croatia, Hungary, Israel, United Kingdom, Korea, Republic of, South Africa, United States, ... and more
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SanofiCompletedHyponatremia | Inappropriate ADH SyndromeUnited States, France, Brazil, Russian Federation, Australia, Germany, Switzerland, Belgium, Hungary, Hong Kong, Canada
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SanofiCompletedLiver Cirrhosis | AscitesUnited States, France, Brazil, Poland, Romania, Russian Federation, Italy, Netherlands, Portugal, Sweden, Belgium, Argentina, Croatia, Denmark, Hungary, Israel, Spain, Chile, Canada, United Kingdom, Australia
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SanofiCompletedHyponatremia | Inappropriate ADH SyndromeUnited States, Canada, Brazil, Germany, Netherlands, Portugal, Spain, Belgium, Croatia, Hungary, Hong Kong
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SanofiCompletedCongestive Heart FailureUnited States, Canada, Poland, Romania, Portugal, Sweden, Belgium, Argentina, Denmark, Hungary, Israel, Australia, Chile, South Africa, Greece
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SanofiTerminatedLiver Cirrhosis | AscitesFrance, Canada, Brazil, Poland, Romania, Russian Federation, Australia, Germany, Spain, Turkey, Bulgaria, Malaysia, Serbia, Singapore, Belgium, Czech Republic, Mexico, Chile, United States, Argentina, Bosnia and Herzegovina
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SanofiTerminatedHyponatremia | Inappropriate ADH SyndromeUnited States