Obesity, Weight Loss
Conditions
Keywords
Cholesterol, HDL, triglycerides, insulin, blood glucose
Brief summary
The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg. Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.
Interventions
once daily
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body Mass index (BMI) of at least 30 kg/m² or BMI \>27 kg/m² with associated risk factors such as type 2 diabetes or dyslipidemia
Exclusion criteria
* Weight loss \> 5 kg within 3 months prior to screening Visit. * Presence of any clinically significant endocrine disease including the presence of type 1 diabetes * 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 * Previous participation in a clinical study with rimonabant * Administration of other investigational drugs, anti-obesity drugs or other drugs for weight reduction * Pregnancy and absence of effective contraceptive method for females of childbearing potential * Exenatide * Insulin therapy * Recent change or need for change in the oral antidiabetic treatment * Recent change or need for change in the lipid lowering treatment * Presence of severe renal or hepatic impairment The above information is not intented to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in weight from baseline to 12 months | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: - Absolute change in waist circumference from baseline - Relative change in HDL-Cholesterol and in Triglycerides from baseline - Absolute change in Fasting Plasma Glucose from baseline | 12 months |
| Safety : Vital signs, adverse events, laboratory tests | 12 months |
Countries
Croatia, Finland, Hungary, Netherlands, Romania
Outcome results
None listed