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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00239967
First received: October 13, 2005
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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
Dyslipidemia
Obesity
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00239967

Locations
United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Brazil
Sanofi-aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-aventis Administrative Office
Laval, Canada
Denmark
Sanofi-aventis Administrative Office
Horsholm, Denmark
Hong Kong
Sanofi-aventis Administrative Office
Causeway Bay, Hong Kong
Italy
Sanofi-aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-aventis Administrative Office
Mexico, Mexico
Singapore
Sanofi-aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-aventis Administrative Office
Midrand, South Africa
Sweden
Sanofi-aventis Administrative Office
Bromma, Sweden
Taiwan
Sanofi-aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov 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:
dyslipidemia
obesity

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014