Japanese Dose-Response Study of Rimonabant in Obese Patients
NCT ID: NCT00459004
Last Updated: 2009-04-07
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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COMPLETED
PHASE2
527 participants
INTERVENTIONAL
2004-10-31
2006-04-30
Brief Summary
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The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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rimonabant (SR141716)
Eligibility Criteria
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Inclusion Criteria
* Viceral Fat Area ≥ 100 cm²
* Diet therapy for more than 8 weeks before start of the placebo observation period
* Stable weight (variation \< ±3kg within 8 weeks before start of observation period)
* At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension
20 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Kohji SHIRAI, Professor
Role: PRINCIPAL_INVESTIGATOR
Toho University Sakura Medical Center, Japan
Locations
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Sanofi-Aventis
Tokyo, , Japan
Countries
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Other Identifiers
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DRI5747
Identifier Type: -
Identifier Source: org_study_id
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