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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Korea University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00926055
First received: June 22, 2009
Last updated: June 23, 2011
Last verified: June 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00926055

Contacts
Contact: Hye Jin Yoo, MD. PhD 82-2-2626-3045 deisy21@medimail.co.kr

Locations
Korea, Republic of
Korea University Guro Not yet recruiting
Seoul, Korea, Republic of, 152-050
Principal Investigator: Kyung Mook Choi, MD         
Sub-Investigator: Hye Jin Yoo, MD         
Sub-Investigator: Seung Eun Kim, MD         
Sponsors and Collaborators
Korea University
  More Information

No publications provided

Responsible Party: Kyung Mook Choi, Korea University
ClinicalTrials.gov Identifier: NCT00926055     History of Changes
Other Study ID Numbers: R01-2007-000-20546-0
Study First Received: June 22, 2009
Last Updated: June 23, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
high risk patients in atherosclerosis

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Ezetimibe
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014