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

Phase 3

Terminated

• Conditions: Obesity; Weight Loss
• Interventions: Drug: rimonabant (SR141716)

• Registration Number: NCT00678483
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-16
• Last Update Posted: 2009-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 331

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	rimonabant (SR141716)	10 mg
2	rimonabant (SR141716)	20 mg

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change in weight from baseline to 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Sanofi- Aventis Administrative Office; 🇭🇺 Budapest, Hungary

Sanofi-Aventis Administrative Office; 🇷🇴 Bucuresti, Romania