Patients with BMI > or = 30 kg/m2 or BMI > 27 kg/m2 with associated risk factors such as Type 2 Diabetes mellitus or Dyslipidemia MedDRA version: 10.1 Level: LLT Classification code 10045260 Term: MedDRA version: 10.1 Level: LLT Classification code 10058108 Term:
Conditions
Sponsors
sanofi-aventis recherche & developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are to be applied for entering the open run-in period - Male or female patients aged > or = 18 years. - BMI > or = 30 kg/m² or BMI > 27 kg/m² with associated risk factor(s) such as type 2 diabetes or dyslipidemia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A. Exclusion criteria related to study methodology Exclusion criteria for entering the open, run-in period - Weight loss > 5 kg within three months prior to screening Visit. - Patients with conditions/concomitant diseases making them non evaluable for the efficacy assessment: - Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to screening Visit). - Presence of type 1 diabetes. - Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient’s safety or successful participation in the study, including uncontrolled serious psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempt - Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer. - Previous participation in a clinical study with rimonabant. - Administration of other investigational drugs within 30 days prior to screening Visit. - Absence of effective contraceptive method for females of childbearing potential. - Pregnancy. - Related to previous or concomitant medications that could bias evaluation of primary and secondary endpoints: - Within 3 months prior to screening visit and/or between the screening visit and the first visit of the open, run-in period: - Administration of anti-obesity drugs (sibutramine, orlistat). - Administration of other drugs for weight reduction (e.g., phentermine, amphetamines). - Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy) - Exenatide or other GLP-1 analogues, - Sitagliptin, - Insulin therapy. - Prolonged administration (more than one week) of neuroleptics. - Within 6 weeks prior to screening visit and/or between the screening visit and the first visit of the open, run-in period: - Administration of herbal preparations for weight reduction. - Administration of systemic long-acting corticosteroids. - Prolonged use (more than one week) of other systemic corticosteroids. - Change in the oral antidiabetic treatment (change of the dose, cessation, introduction, substitution). - Change in the lipid lowering treatment. - Change in the treatment with diuretics. - Related to laboratory findings: - Positive urine pregnancy test in females of childbearing potential at screening visit and the first visit of the open, run-in period. - Any relevant abnormality that could interfere with the efficacy or the safety assessments during the study drug administration. - Patients considered by the Investigator unsuitable candidates to receive an investigational drug. - Refusal or inability to give informed consent to participate to the study. - Presence of any other condition (e.g. geographic, social …) actual or anticipated, that the Investigator feels, would restrict or limit the patient’s participation for the duration of the study. Exclusion criteria for entering the double-blind treatment period - Absence of effective contraceptive method for females of childb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, over a period of 12 months (1 year), 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 Objective: - To assess the effect of rimonabant over a period of 12 months (1 year) on: - Waist circumference, - HDL-Cholesterol and triglycerides (TG), - Fasting plasma glucose (FPG), fasting-insulin. - To evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months followed by a 75-day post treatment follow-up period (1 year + 75 days), after randomization, in overweight/obese patients.;Primary end point(s): Absolute change in weight from baseline (randomization) to 12 months (1year). | — |
Countries
Finland, Hungary, Netherlands
Outcome results
None listed