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Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol

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: NCT01008345
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : November 6, 2009
Sponsor:
Collaborator:
Pharmaline, Lebanon
Information provided by:
Hotel Dieu de France Hospital

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Drug: ezetimibe Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ezetimibe on Oxidized LDL Cholesterol
Study Start Date : September 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009


Arm Intervention/treatment
Experimental: ezetimibe
will receive the active treatment with ezetimibe and statin
Drug: ezetimibe
Patients will receive 10 mg/day of ezetimibe for 8 weeks

Placebo Comparator: placebo Drug: ezetimibe
Patients will receive 10 mg/day of ezetimibe for 8 weeks




Primary Outcome Measures :
  1. level of oxidized LDL cholesterol at end of study [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :
  1. small dense LDL level [ Time Frame: 8 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01008345


Locations
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Lebanon
Hotel Dieu de France Hospital
Achrafieh, Beirut, Lebanon, 0000
Sponsors and Collaborators
Hotel Dieu de France Hospital
Pharmaline, Lebanon
Investigators
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Principal Investigator: rabih azar, md Hotel Dieu
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Responsible Party: Rabih Azar, MD, Hotel Dieu de France Hospital
ClinicalTrials.gov Identifier: NCT01008345    
Other Study ID Numbers: pharmaline1
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents