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

October 13, 2005
April 6, 2009
May 2005
February 2007   (final data collection date for primary outcome measure)
HDL cholesterol and TG plasma levels over a period of one year.
Same as current
Complete list of historical versions of study NCT00239967 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dyslipidemia
  • Obesity
  • Drug: Rimonabant (SR141716)
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
803
February 2007
February 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Australia,   Brazil,   Canada,   Taiwan,   Hong Kong,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Singapore,   South Africa,   Sweden,   United States
 
NCT00239967
EFC5823
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP