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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00239967
Registration number
NCT00239967
Ethics application status
Date submitted
13/10/2005
Date registered
17/10/2005
Date last updated
7/04/2009
Titles & IDs
Public title
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
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Scientific 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
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Secondary ID [1]
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EFC5823
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Universal Trial Number (UTN)
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Trial acronym
ADAGIO-lipids
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia
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Obesity
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant (SR141716)
Treatment: Drugs - Placebo
Treatment: Drugs: Rimonabant (SR141716)
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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HDL cholesterol and TG plasma levels over a period of one year.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2007
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Sample size
Target
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Accrual to date
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Final
803
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-aventis Administrative Office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Brazil
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State/province [2]
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Sao Paulo
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Canada
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State/province [3]
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Laval
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Denmark
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Horsholm
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Hong Kong
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State/province [5]
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Causeway Bay
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Italy
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State/province [6]
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Milano
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Country [7]
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Korea, Republic of
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State/province [7]
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Seoul
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Country [8]
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Malaysia
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State/province [8]
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Kuala Lumpur
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Mexico
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State/province [9]
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Mexico
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Singapore
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State/province [10]
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Singapore
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South Africa
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State/province [11]
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Midrand
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Country [12]
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Sweden
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State/province [12]
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Bromma
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Country [13]
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Taiwan
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State/province [13]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00239967
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ICD CSD
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00239967
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