Back to resultsEffect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol
Primary Purpose
Coronary Artery Disease, Diabetes
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- CAD or CAD equivalent
Exclusion Criteria:
- Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage >2 Creatinin clearance < 30 ml/min
Sites / Locations
- Hotel Dieu de France Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ezetimibe
placebo
Arm Description
will receive the active treatment with ezetimibe and statin
Outcomes
Primary Outcome Measures
level of oxidized LDL cholesterol at end of study
Secondary Outcome Measures
small dense LDL level
Full Information
NCT ID
NCT01008345
First Posted
November 4, 2009
Last Updated
November 5, 2009
Sponsor
Hotel Dieu de France Hospital
Collaborators
Pharmaline, Lebanon
1. Study Identification
Unique Protocol Identification Number
NCT01008345
Brief Title
Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol
Official Title
Effect of Ezetimibe on Oxidized LDL Cholesterol
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hotel Dieu de France Hospital
Collaborators
Pharmaline, Lebanon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ezetimibe
Arm Type
Experimental
Arm Description
will receive the active treatment with ezetimibe and statin
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Intervention Description
Patients will receive 10 mg/day of ezetimibe for 8 weeks
Primary Outcome Measure Information:
Title
level of oxidized LDL cholesterol at end of study
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
small dense LDL level
Time Frame
8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CAD or CAD equivalent
Exclusion Criteria:
Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage >2 Creatinin clearance < 30 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rabih azar, md
Organizational Affiliation
Hotel Dieu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de France Hospital
City
Achrafieh
State/Province
Beirut
ZIP/Postal Code
0000
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol
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