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NCT00926055 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00926055
Other study ID # R01-2007-000-20546-0
Secondary ID
Status Withdrawn
Phase N/A
First received June 22, 2009
Last updated March 17, 2015
Start date September 2011

Study information
Verified date June 2010
Source Korea University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ezetrol (Ezetimibe)
Ezetrol - 10 mg once daily for 3 months
• Vytorin (Ezetimibe + Simvastatin)
Vytorin - 10/20 mg once daily for 3 months

Locations
Country Name City State
Korea, Republic of Korea University Guro Seoul

Sponsors (1)
Lead Sponsor Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The difference of FDG uptake quantified by measuring the standardized uptake value (SUV) corrected for body weight according to the treatment groups 3 months later No
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