Intima Media Thickness Regression in Dyslipidemic Teenagers

NCT01768481

Last updated date
Study Location
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, H1T 2M4, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
14-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Obesity

- Abnormal Triglyceride levels (>1.7mmol/L).

- Abnormal HDL-C levels (1.0mmol/L)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Abnormal thyroid unfction (not treated)


- Diabetes

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Obesity, DyslipidemiaIntima Media Thickness Regression in Dyslipidemic Teenagers
NCT01768481
  1. Montréal, Quebec
ALL GENDERS
14 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Intima Media Thickness Regression in Dyslipidemic Teenagers
Official Title  ICMJE Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
Brief Summary Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.
Detailed Description Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Dyslipidemia
Intervention  ICMJE
  • Drug: Atorvastatin
    10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
    Other Names:
    • Statin
    • Lipitor
  • Drug: sugar pill
    placebo controlled arm receives similarly looking placebo.
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Statin
    Atorvastatin 10 mg every day for one year
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Sugar pill
    Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.
    Intervention: Drug: sugar pill
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: January 11, 2013)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obesity
  • Abnormal Triglyceride levels (>1.7mmol/L).
  • Abnormal HDL-C levels (1.0mmol/L)

Exclusion Criteria:

  • Abnormal thyroid unfction (not treated)
  • Diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01768481
Other Study ID Numbers  ICMJE HMR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laurent Legault, Université de Montréal
Study Sponsor  ICMJE Université de Montréal
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Laurent Legault, MDHopital Maisonneuve-Rosemont, UMontreal
PRS Account Université de Montréal
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP