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

This study has been withdrawn prior to enrollment.
Information provided by:
Korea University Identifier:
First received: June 22, 2009
Last updated: March 17, 2015
Last verified: June 2010
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.

Condition Intervention
Atherosclerosis Drug: Ezetrol (Ezetimibe) Drug: Vytorin (Ezetimibe + Simvastatin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography

Resource links provided by NLM:

Further study details as provided by Korea University:

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 [ Time Frame: 3 months later ]

Enrollment: 0
Study Start Date: September 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00926055

Korea, Republic of
Korea University Guro
Seoul, Korea, Republic of, 152-050
Sponsors and Collaborators
Korea University
  More Information

Responsible Party: Kyung Mook Choi, Korea University Identifier: NCT00926055     History of Changes
Other Study ID Numbers: R01-2007-000-20546-0
Study First Received: June 22, 2009
Last Updated: March 17, 2015

Keywords provided by Korea University:
high risk patients in atherosclerosis

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ezetimibe, Simvastatin Drug Combination
Fluorodeoxyglucose F18
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents processed this record on September 21, 2017