Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)

Exclusion Criteria

• •Subjects whose body mass index (BMI=weight \[kg\]/height2\[m\]) is \>=30 kg/m2 at Visit 3 (Baseline Visit).
• •Subjects who consume \>14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
• •Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
• •Women who are pregnant or nursing.
• •Subjects who have not observed the designated washout periods for any of the prohibited medications.
• •Subjects who have the following medical conditions:
• •* Congestive heart failure defined by New York Heart Association (NYHA) as Class III or IV.
• •* Uncontrolled cardiac arrhythmia.
• •* Myocardial infarction, acute coronary insufficiency, coronary artery bypass surgery, or angioplasty within 3 months of Visit 3 (Baseline Visit).
• •* Unstable or severe peripheral artery disease within 3 months of Visit 3 (Baseline Visit).
• •* Newly diagnosed or currently unstable angina pectoris.
• •* Uncontrolled hypertension (treated or untreated) with systolic blood pressure \>160 mmHg or diastolic \>100 mmHg at Visit 3 (Baseline Visit).
• •* Type I or Type II diabetes mellitus.
• •* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, i.e., secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism (TSH above upper limit of normal) at Visit 3. Subjects with a history of hypothyroidism who are on a stable therapy of thyroid hormone replacement for at least 6 weeks are eligible for enrollment if thyroid-stimulating hormone (TSH) levels are within normal limits at Visit 3 (Baseline Visit).
• •* Impaired renal function (creatinine \> 2.0 mg/dL) or nephrotic syndrome at Visit 3 (Baseline Visit).
• •* Disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
• •* Known human immunodeficiency virus (HIV) positive.
• •* Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
• •* History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
• •Subjects who are on any of the following concomitant medications:
• •* Medications that are potent inhibitors of CYP3A4, including cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of grapefruit juice (\>1 quart/day).
• •* Lipid-lowering agent: niacin (\>200 mg/day) and resins taken within 5 weeks, fibric acid derivatives taken within 8 weeks, and probucol taken within one year prior to Visit 3 (Baseline Visit).
• •* Over the counter lipid lowering agents such as fish oils, garlic and cholestin taken within 5 weeks prior to Visit 3 (Baseline Visit).
• •* Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks prior to Visit 3 (Baseline Visit).
• •* Subjects who are currently using cardiovascular medication and have not been on a stable regimen for at least 6 weeks prior to Visit 3 (Baseline Visit) and it is expected to change during the study.
• •* Subjects who are currently using psyllium, other fiber-based laxatives, and/or any other over-the-counter (OTC) therapy known to affect serum lipid levels (phytosterol margarine), and have not been on a stable regimen for at least 5 weeks prior to study entry Visit 3 (Baseline Visit) and who do not agree to remain on this regimen throughout the study.
• •* Subjects who are currently using orlistat or sibutramine.