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

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

Tracking Information

• First Submitted Date: October 13, 2005
• First Posted Date: October 17, 2005
• Last Update Posted Date: April 7, 2009
• Study Start Date: May 2005
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 13, 2005): HDL cholesterol and TG plasma levels over a period of one year.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Dyslipidemia
• Obesity

Intervention

• Drug: Rimonabant (SR141716)
• Drug: Placebo

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 6, 2008): 803
• Original Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Brazil, Canada, Denmark, Hong Kong, Italy, Korea, Republic of, Malaysia, Mexico, Singapore, South Africa, Sweden, Taiwan, United States

Administrative Information

• NCT Number: NCT00239967
• Other Study ID Numbers: 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: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: ICD CSD; Sanofi

• PRS Account: Sanofi
• Verification Date: April 2009