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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Weight Loss; Obesity

Treatments: Drug: rimonabant (SR141716)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00678483

EFC10139

EudraCT : 2007-002492-14

Details and patient eligibility

About

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.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 2 patient groups

1

Experimental group

Description:

10 mg

Treatment:

Drug: rimonabant (SR141716)

2

Experimental group

Description:

20 mg

Treatment:

Drug: rimonabant (SR141716)