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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00678483
Recruitment Status : Terminated (Company decision taken in light of demands by certain national health authorities)
First Posted : May 15, 2008
Last Update Posted : June 17, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Drug: rimonabant (SR141716) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
10 mg
Drug: rimonabant (SR141716)
once daily
Experimental: 2
20 mg
Drug: rimonabant (SR141716)
once daily

Primary Outcome Measures :
  1. The primary endpoint is the change in weight from baseline to 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety : Vital signs, adverse events, laboratory tests [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00678483

Sanofi-Aventis Administrative Office
Zagreb, Croatia
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi- Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sponsors and Collaborators
Study Director: ICD Sanofi

Responsible Party: ICD, sanofi-aventis Identifier: NCT00678483     History of Changes
Other Study ID Numbers: EFC10139
EudraCT : 2007-002492-14
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by Sanofi:
blood glucose

Additional relevant MeSH terms:
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs