A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess the Long-Term Effect, Over 1 Year, of Rimonabant 10 mg in Comparison With Rimonabant 20 mg After an Initial Treatment Period of 6 Months With Rimonabant 20 mg in Overweight or Obese Patients
Overview
- Phase
- Phase 3
- Intervention
- rimonabant (SR141716)
- Conditions
- Obesity
- Sponsor
- Sanofi
- Enrollment
- 331
- Locations
- 2
- Primary Endpoint
- The primary endpoint is the change in weight from baseline to 12 months
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
10 mg
Intervention: rimonabant (SR141716)
2
20 mg
Intervention: rimonabant (SR141716)
Outcomes
Primary Outcomes
The primary endpoint is the change in weight from baseline to 12 months
Time Frame: 12 months
Secondary Outcomes
- 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)