An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes
NCT ID: NCT00577148
Last Updated: 2016-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
89 participants
INTERVENTIONAL
2008-02-29
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rimonabant
Rimonabant 20 mg once daily.
Rimonabant
Tablet, oral administration
Placebo
Placebo (for Rimonabant) once daily.
Placebo (for Rimonabant)
Tablet, oral administration
Interventions
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Rimonabant
Tablet, oral administration
Placebo (for Rimonabant)
Tablet, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of Type 1 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Shanghai, , China
Sanofi-Aventis Administrative Office
Bogotá, , Colombia
Sanofi-Aventis Administrative Office
Zagreb, , Croatia
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Makati City, , Philippines
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
San Juan, , Puerto Rico
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Countries
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Other Identifiers
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2007-003013-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC10144
Identifier Type: -
Identifier Source: org_study_id
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