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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: rimonabant (SR141716)
  • once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 10 mg
• Experimental: 2
  • 20 mg

Primary Measures

• The primary endpoint is the change in weight from baseline to 12 months
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: 12 months
    Safety Issue?: No
• Safety : Vital signs, adverse events, laboratory tests
  • Time Frame: 12 months
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00678483

Study ID Number: EFC10139

ClinicalTrials.gov Identifier: NCT00678483

Health Authority: Romania: Ministry of Public Health