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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

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

• 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.