NCT01768481

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

5.9 years

First QC Date

January 8, 2013

Last Update Submit

January 11, 2013

Conditions

ObesityDyslipidemia

Keywords

ObesityDyslipidemiaCholesterolIntima media thickness

Outcome Measures

Primary Outcomes (1)

  • carotid intima media thickness

    Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)

    12 months

Secondary Outcomes (1)

  • weight

    12 months

Other Outcomes (11)

  • Lipid profile

    6 months

  • lipid profile

    12 months

  • BMI

    12 months

  • +8 more other outcomes

Study Arms (2)

Statin

EXPERIMENTAL

Atorvastatin 10 mg every day for one year

Drug: Atorvastatin

Sugar pill

PLACEBO COMPARATOR

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

Drug: sugar pill

Interventions

AtorvastatinDRUG

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

Also known as: Statin, Lipitor
Statin
sugar pillDRUG

placebo controlled arm receives similarly looking placebo.

Also known as: placebo
Sugar pill

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Abnormal thyroid unfction (not treated)
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

ObesityDyslipidemias

Interventions

AtorvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsSugars

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesCarbohydrates

Study Officials

  • Laurent Legault, MD

    Hopital Maisonneuve-Rosemont, UMontreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 15, 2013

Study Start

January 1, 2004

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

CA(1)