Intima Media Thickness Regression in Dyslipidemic Teenagers

NCT ID: NCT01768481

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-06-30

Brief Summary

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Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.

Detailed Description

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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.

Conditions

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Obesity Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Statin

Atorvastatin 10 mg every day for one year

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year

Sugar pill

Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type DRUG

placebo controlled arm receives similarly looking placebo.

Interventions

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Atorvastatin

10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year

Intervention Type DRUG

sugar pill

placebo controlled arm receives similarly looking placebo.

Intervention Type DRUG

Other Intervention Names

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Statin Lipitor placebo

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Abnormal thyroid unfction (not treated)
* Diabetes
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Laurent Legault

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurent Legault, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Maisonneuve-Rosemont, UMontreal

Locations

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Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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HMR

Identifier Type: -

Identifier Source: org_study_id

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