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An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients (ADAGIO-lipids)

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.
ClinicalTrials.gov Identifier: NCT00239967
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : April 7, 2009
Information provided by:

Brief Summary:
The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.

Condition or disease Intervention/treatment Phase
Dyslipidemia Obesity Drug: Rimonabant (SR141716) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 803 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Two-Arm Placebo-Controlled, Parallel-Group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients
Study Start Date : May 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. HDL cholesterol and TG plasma levels over a period of one year.

Secondary Outcome Measures :
  1. Cholesterol content of HDL2 and HDL3 subfractions,HDL particle size,ApoB,ApoA1,ApoCIII, FFA, indeces of LDL size,hs-CRP,adipokines, fasting glycemia and insulinemia, HbA1c),waist and weight measurements,visceral fat measured by CT scan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients aged >= 18 years
  • Waist circumference > 102 cm in men and > 88 cm in women
  • Dyslipidemia consisting of:
  • Triglyceridemia >= 1.5g/L (i.e. 1.69mmol/L) and ≤ 7.0g/L (i.e. 7.90mmol/L) AND/OR
  • HDL cholesterol < 50mg/dL (1.29mmol/L) in women, < 40mg/dL (1.04mmol/L) in men
  • If patient with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication (excluding glitazones) and should not be on insulin therapy
  • Written informed consent

Exclusion Criteria:

  • Weight change > 5 kg within 3 months prior to screening visit
  • Pregnancy or lactation, or women planning to become pregnant
  • Absence of medically approved contraceptive methods for females of childbearing potential
  • Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject's participation for the duration of the study.
  • Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator
  • History of severe depression that could be defined as depression which necessitated the patient to be hospitalized, or patients with 2 or more recurrent episodes of depression or a history of suicide attempt.
  • Presence or history of DSM-IV bulimia or anorexia nervosa- Positive test for hepatitis B surface antigen and/or hepatitis C antibody; Abnormal TSH level (TSH > ULN or < LLN ); Hemoglobin < 11g/dL and/or neutrophils > 1,500/mm3 and/or platelets < 100,000/mm3; Positive urine pregnancy test in females of childbearing potential.
  • Within 3 months prior to screening visit and between the screening and the inclusion visit:
  • Administration of anti obesity drugs (e.g., sibutramine, orlistat)
  • Administration of other drugs for weight reduction including herbal preparations (phentermine, amphetamines)
  • Thyroid preparations or thyroxine treatment (except in patients on replacement therapy on a stable dose)
  • If patients with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication for at least 3 months and should not be expected to receive insulin therapy within 12 months: Insulin, Glitazones
  • Any change in lipid lowering treatment (i.e. introduction of a new drug, change, cessation)- Administration of systemic long-acting corticosteroids- Prolonged use (more than 1 week) of systemic corticosteroids (or if daily dosage > 1000 µg equivalent beclomethasone
  • Prolonged administration (more than one week) of antidepressants (including bupropion)
  • Prolonged administration (more than one week) of neuroleptics.

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 ClinicalTrials.gov identifier (NCT number): NCT00239967

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United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Sanofi-aventis Administrative Office
Sao Paulo, Brazil
Sanofi-aventis Administrative Office
Laval, Canada
Sanofi-aventis Administrative Office
Horsholm, Denmark
Hong Kong
Sanofi-aventis Administrative Office
Causeway Bay, Hong Kong
Sanofi-aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-aventis Administrative Office
Seoul, Korea, Republic of
Sanofi-aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-aventis Administrative Office
Mexico, Mexico
Sanofi-aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-aventis Administrative Office
Midrand, South Africa
Sanofi-aventis Administrative Office
Bromma, Sweden
Sanofi-aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00239967    
Other Study ID Numbers: EFC5823
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs