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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
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
Secondary ID [1] 0 0
EFC5823
Universal Trial Number (UTN)
Trial acronym
ADAGIO-lipids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 0 0
Obesity 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant (SR141716)
Treatment: Drugs - Placebo

Treatment: Drugs: Rimonabant (SR141716)


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HDL cholesterol and TG plasma levels over a period of one year.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
803
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
Denmark
State/province [4] 0 0
Horsholm
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Causeway Bay
Country [6] 0 0
Italy
State/province [6] 0 0
Milano
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Malaysia
State/province [8] 0 0
Kuala Lumpur
Country [9] 0 0
Mexico
State/province [9] 0 0
Mexico
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
South Africa
State/province [11] 0 0
Midrand
Country [12] 0 0
Sweden
State/province [12] 0 0
Bromma
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00239967
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries