Japanese Dose-Response Study of Rimonabant in Obese Patients
Status and phase
Completed
Phase 2
Conditions
Obesity
Treatments
Drug: rimonabant (SR141716)
Details and patient eligibility
About
The primary objective is to verify the dose-response relationship of rimonabant on body weight change.
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.
Enrollment
527 patients
Sex
All
Ages
20 to 70 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Body Mass Index ≥25 kg/m²
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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