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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Recruitment Status : Withdrawn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:

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.

Condition or disease Intervention/treatment
Atherosclerosis Drug: Ezetrol (Ezetimibe) Drug: Vytorin (Ezetimibe + Simvastatin)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926055


Locations
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
ClinicalTrials.gov Identifier: NCT00926055     History of Changes
Other Study ID Numbers: R01-2007-000-20546-0
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: June 2010

Keywords provided by Korea University:
high risk patients in atherosclerosis

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Deoxyglucose
Fluorodeoxyglucose F18
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Radiopharmaceuticals
Antiviral Agents
Anti-Infective Agents