abdominally obese patients with dyslipidemia with or without other comorbidities MedDRA version: 8.1 Level: LLT Classification code 10059179 Term: Abdominal obesity
Conditions
Sponsors
sanofi aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent must be obtained in writing for all subjects at enrollment into the study, 2) Male or female 18-75 years of age, 3) BMI > 27 kg/m² and 88 cm in women; > 102 cm in men, 6) HDL cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed (excluded by pregnancy test), 2) Absence of medically approved contraceptive methods for female of childbearing potential, 3) History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day), 4) Weight change > 5 kg within 3 months prior to screening visit, 5) History of surgical procedures for weight loss (e.g., stomach stapling, bypass), 6) History of bulimia or anorexia nervosa as per DSM-IV criteria (see Appendix A), 7) Presence of any clinically significant endocrine disease according to the investigator, in particular known abnormal TSH and free T4 blood level (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status), 8) Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose = 126 mg/dl, 9) Triglyceride level > 400 mg/dL (4.52 mmol/L), 10) Systolic blood pressure > 160 mm Hg or diastolic blood pressure >100 mmHg at screening visit, 11) Known severe renal dysfunction (creatinine clearance 3 times the upper limit of normal at screening, 13) Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient’s safety or limit his/her successful participation to the study. 14) Uncontrolled serious psychiatric illness such as a major depression, 15) History of alcohol or other substance abuse, 16) Hypersensitivity /intolerance to the active substance or to any of the excipients such as lactose, Concomitant medications prior to study entry: 17) Administration of any investigational treatment (drug or device) within 30 days prior to screening, 18) Previous participation in a Rimonabant study, 19) Administration of any of the following within 3 months prior to screening visit: a. anti obesity drugs (eg, sibutramine, orlistat), b. other drugs for weight reduction (phentermine, amphetamines), c. herbal preparations for weight reduction, d. nicotinic acid, fibrates or bile acid sequestrants , e. Prolonged use (more than one week) of systemic corticosteroids. 20) Current use of antidepressants (including bupropion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of Rimonabant 20 mg on changes in HDL-C, triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities.;Secondary Objective: To determine the effect of 12 months Rimonabant treatment versus placebo on changes in • Waist circumference and body weight at each visit • Glycemic parameters : FPG, fasting insulinemia, HbA1c, • Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels • Inflammatory parameter :Hs-CRP All these laboratory parameters will be measured prior to baseline, month 3, month 6 and month 12. • Quality of life : IWQOL questionnaire completed at baseline, month 3, month 6, month 9 and month 12. • Blood pressure at each visit To assess the safety of 12 months Rimonabant treatment versus placebo in these patients. • Safety parameters : - Incidence of adverse events in each group, including neuro-psychiatric adverse events - Standard laboratory assessments prior to baseline and month 12 ;Primary end point(s): The main endpoint is a co-primary endpoints with two criteria: • The relative (to baseline value) change in HDL cholesterol between month 12 and baseline • The relative (to baseline value) change in Triglycerides between month 12 and baseline | — |
Countries
Czech Republic, Finland, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovenia, Sweden, United Kingdom
Outcome results
None listed