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

Tracking Information
First Submitted Date ICMJE	October 13, 2005
First Posted Date ICMJE	October 17, 2005
Last Update Posted Date	April 7, 2009
Study Start Date ICMJE	May 2005
Actual Primary Completion Date	February 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 13, 2005)	HDL cholesterol and TG plasma levels over a period of one year.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00239967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 13, 2005)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
Official Title ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Dyslipidemia; Obesity
Intervention ICMJE	Drug: Rimonabant (SR141716); Drug: Placebo
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 6, 2008)	803
Original Enrollment ICMJE; (submitted: October 13, 2005)	740
Actual Study Completion Date	February 2007
Actual Primary Completion Date	February 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Brazil, Canada, Denmark, Hong Kong, Italy, Korea, Republic of, Malaysia, Mexico, Singapore, South Africa, Sweden, Taiwan, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00239967
Other Study ID Numbers ICMJE	EFC5823
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	ICD Study Director, sanofi-aventis
Study Sponsor ICMJE	Sanofi
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: ICD CSD Sanofi
PRS Account	Sanofi
Verification Date	April 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP