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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Coronary Artery Disease Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ezetimibe

will receive the active treatment with ezetimibe and statin

Group Type EXPERIMENTAL

ezetimibe

Intervention Type DRUG

Patients will receive 10 mg/day of ezetimibe for 8 weeks

placebo

Group Type PLACEBO_COMPARATOR

ezetimibe

Intervention Type DRUG

Patients will receive 10 mg/day of ezetimibe for 8 weeks

Interventions

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ezetimibe

Patients will receive 10 mg/day of ezetimibe for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No