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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: October 13, 2005
Last updated: April 6, 2009
Last verified: April 2009

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 Intervention Phase
Drug: Rimonabant (SR141716)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • 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

Enrollment: 803
Study Start Date: May 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00239967

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
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00239967     History of Changes
Other Study ID Numbers: EFC5823
Study First Received: October 13, 2005
Last Updated: April 6, 2009
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Sweden: Medical Products Agency

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases processed this record on April 17, 2014