Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Weight Loss

Intervention / Treatment
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* Drug: rimonabant (SR141716)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>10 mg | Drug: rimonabant (SR141716)<br>* once daily<br>|
| Experimental: 2<br>20 mg | Drug: rimonabant (SR141716)<br>* once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change in weight from baseline to 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, HDL, triglycerides, insulin, blood glucose