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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00576667 |
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Date of registration:
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18/12/2007 |
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Primary sponsor: |
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Public title:
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An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
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Scientific title:
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A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (NASH) |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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165 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00576667 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Colombia
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Croatia
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France
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Germany
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Hungary
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Italy
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Malaysia
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Mexico
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Philippines
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Poland
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Portugal
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Puerto Rico
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Romania
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Spain
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Switzerland
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with diagnosis of NASH
Exclusion Criteria:
- Excessive alcohol use
- Presence of diabetes mellitus
- Other chronic liver disease
- Previous or current hepatocellular carcinoma
- Use of medication known to cause steatosis
- Previous bariatric surgery
- Pregnancy or breastfeeding
- Presence of any severe medical or psychological condition that, in the opinion of the
investigator, would compromise the patient's safe participation including
uncontrolled serious psychiatric illness such a major depression within the last 2
years, and history of other severe psychiatric disorders.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fatty Liver
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Intervention(s)
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Drug: Placebo
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Drug: rimonabant (SR141716)
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Primary Outcome(s)
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Change in histologic features of NASH from baseline to end of treatment liver biopsy
[Time Frame: 24 or more months]
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Secondary Outcome(s)
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Liver fibrosis, AST/ALT, serum hyaluronate
[Time Frame: 24 or more months]
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Secondary ID(s)
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EFC10143
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EudraCT 2007-003013-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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