Intima Media Thickness Regression in Dyslipidemic Teenagers | NCT01768481

Studies
Intima Media Thickness Regression in Dyslipidemic Teenagers

NCT01768481

Sponsor

Université de Montréal

Status

Completed

Last Update Posted

Jan 15, 2013Estimated

Enrollment

16Actual

Phase

Phase 3

Conditions

Obesity
Dyslipidemia

Interventions

Atorvastatin
sugar pill

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Dec 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 11, 2013

First Posted Date

Jan 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2013

Last Update Posted Date

Jan 15, 2013Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year	Statin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
weight	weight, height and BMI recorded before and after intervention	12 months

Other Outcomes

Measure	Description	Time Frame
Lipid profile	Complete lipid profile were recorded at baseline , 6 months and 12 months after intervention.	6 months
lipid profile	Lipid profile measured at end of study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Abnormal thyroid unfction (not treated)
Diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent Legault, MD	Hopital Maisonneuve-Rosemont, UMontreal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Maisonneuve-Rosemont		Montreal	Quebec	H1T 2M4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D000073893	Sugars

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided