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

March 17, 2015 updated by: Korea University

Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
ACTIVE_COMPARATOR: Ezetimibe
Drug: Ezetrol (Ezetimibe)
Ezetrol - 10 mg once daily for 3 months
EXPERIMENTAL: Ezetimibe/Simvastatin
Drug: Vytorin (Ezetimibe + Simvastatin)
Vytorin - 10/20 mg once daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups
Time Frame: 3 months later
3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2012

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (ESTIMATE)

June 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01-2007-000-20546-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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