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

November 5, 2009 updated by: Hotel Dieu de France Hospital

Effect of Ezetimibe on Oxidized LDL Cholesterol

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • Beirut
      • Achrafieh, Beirut, Lebanon, 0000
        • Hotel Dieu de France Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: ezetimibe
Patients will receive 10 mg/day of ezetimibe for 8 weeks
Experimental: ezetimibe
will receive the active treatment with ezetimibe and statin
Drug: ezetimibe
Patients will receive 10 mg/day of ezetimibe for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of oxidized LDL cholesterol at end of study
Time Frame: 8 weeks of treatment
8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
small dense LDL level
Time Frame: 8 weeks of treatment
8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hotel Dieu de France Hospital

Collaborators

Pharmaline, Lebanon

Investigators

  • Principal Investigator: rabih azar, md, Hotel Dieu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 4, 2009

First Submitted That Met QC Criteria

November 4, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2009

Last Update Submitted That Met QC Criteria

November 5, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pharmaline1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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