Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)

NCT ID: NCT00926055

Last Updated: 2015-03-18

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. Therefore, in this study the investigators intend to compare the effect of ezetimibe monotherapy or ezetimibe plus statin combination therapy on the atherosclerosis regression using FDG-PET.

Detailed Description

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Conditions

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Atherosclerosis

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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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Ezetimibe

Group Type ACTIVE_COMPARATOR

Ezetrol (Ezetimibe)

Intervention Type DRUG

Ezetrol - 10 mg once daily for 3 months

Ezetimibe/Simvastatin

Group Type EXPERIMENTAL

Vytorin (Ezetimibe + Simvastatin)

Intervention Type DRUG

Vytorin - 10/20 mg once daily for 3 months

Interventions

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Ezetrol (Ezetimibe)

Ezetrol - 10 mg once daily for 3 months

Intervention Type DRUG

Vytorin (Ezetimibe + Simvastatin)

Vytorin - 10/20 mg once daily for 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* hsCRP \> 2 mg/L and LDL cholesterol \> 130 mm/dL

Exclusion Criteria

* history of cardiovascular disease
* diabetes
* uncontrolled hypertension
* active infection
* previous anti-hyperlipidemic agents within 6 months
* previous steroid or anti-inflammatory agents within 6 months
* liver disease
* renal disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea University

OTHER

Sponsor Role lead

Responsible Party

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Korea University

Locations

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Korea University Guro

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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R01-2007-000-20546-0

Identifier Type: -

Identifier Source: org_study_id

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