Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00239967