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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: rimonabant (SR141716)
    • once daily

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • The primary endpoint is the change in weight from baseline to 12 months
    • Time Frame: 12 months

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 : Vital signs, adverse events, laboratory tests
    • Time Frame: 12 months

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • ICD, sanofi-aventis
  • Overall Official(s)
    • ICD, Study Director, Sanofi

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.