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

Primary Purpose

Atherosclerosis

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ezetrol (Ezetimibe)
Vytorin (Ezetimibe + Simvastatin)
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring high risk patients in atherosclerosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University Guro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Ezetimibe

Ezetimibe/Simvastatin

Arm Description

Outcomes

Primary Outcome Measures

The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
March 17, 2015
Sponsor
Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT00926055
Brief Title
Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Official Title
Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
high risk patients in atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Ezetimibe
Arm Type
Active Comparator
Arm Title
Ezetimibe/Simvastatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ezetrol (Ezetimibe)
Intervention Description
Ezetrol - 10 mg once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Vytorin (Ezetimibe + Simvastatin)
Intervention Description
Vytorin - 10/20 mg once daily for 3 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Korea University Guro
City
Seoul
ZIP/Postal Code
152-050
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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