ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00926055
Recruitment Status : Withdrawn
First Posted : June 23, 2009
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:
Korea University

June 22, 2009
June 23, 2009
March 18, 2015
September 2011
September 2012   (Final data collection date for primary outcome measure)
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 ]
FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight [ Time Frame: baseline, 3 months later ]
Complete list of historical versions of study NCT00926055 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects on Atherosclerosis Regression of Ezetimibe or Ezetimibe Plus Simvastatin; Evaluated by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atherosclerosis
  • Drug: Ezetrol (Ezetimibe)
    Ezetrol - 10 mg once daily for 3 months
  • Drug: Vytorin (Ezetimibe + Simvastatin)
    Vytorin - 10/20 mg once daily for 3 months
  • No Intervention: Control
  • Active Comparator: Ezetimibe
    Intervention: Drug: Ezetrol (Ezetimibe)
  • Experimental: Ezetimibe/Simvastatin
    Intervention: Drug: Vytorin (Ezetimibe + Simvastatin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
120
Not Provided
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00926055
R01-2007-000-20546-0
Yes
Not Provided
Not Provided
Kyung Mook Choi, Korea University
Korea University
Not Provided
Not Provided
Korea University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP