Efficacy and Safety Study of Ezetimibe (SCH 58235, MK-0653) in Addition to Atorvastatin in Participants With Coronary Heart Disease or Multiple Cardiovascular Risk Factors (P00693/MK-0653-030)

Inclusion Criteria:

• Primary hypercholesterolemic participants with known coronary heart disease (CHD) ormultiple risk factors for CHD (≥2) not meeting the target low-density-lipoproteincholesterol (LDL-C) of ≤100 mg/dL (2.59 mmol/L), with plasma LDL-C ≥130 mg/dL (3.37mmol/L) and plasma triglycerides (TG) ≤350 mg/dL (3.99 mmol/L) while on starting-dose (10 mg) atorvastatin at least 4 weeks before initial qualifying lipid determination.
• Participants with heterozygous familial hypercholesterolemia (HeFH) not meeting thetarget LDL-C of ≤100 mg/dL (2.59 mmol/L), with plasma LDL-C ≥130 mg/dL (3.37 mmol/L)and plasma TG ≤350 mg/dL (3.99 mmol/L) while on starting-dose (10 mg) atorvastatin forat least 4 weeks before initial lipid qualifying determination. HeFH is defined by: a)genetic testing; or b) LDL-C >190 mg/dL (4.9 mmol/L) and at least one of thefollowing: (1) xanthomata in first or second degree relative; (2) family history ofmyocardial infarction under age 60 years in a first degree relative or family historyof myocardial infarction under age 50 years in a second degree relative; (3) familyhistory of total cholesterol (TC) >290 mg/dL (>7.5 mmol/L) in a first or second degreerelative.
• All women must have a negative pregnancy test prior to study entry. Women ofchild-bearing potential must agree to practice an effective barrier method of birthcontrol for the duration of the study, as well as for 1 month following studycompletion.
• Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifenemust be maintained on a stable estrogen replacement therapy (ERT), estrogen/progestinhormone replacement therapy (HRT) or raloxifene regimen during the study period.
• Participants must be willing to observe the National Cholesterol Education Program (NCEP) Step I diet as determined by a Ratio of Ingested Saturated fat and Cholesterolto Calories (RISCC) score not greater than 24 throughout this study. Ability tocomplete diet diaries needs to be demonstrated.

Exclusion Criteria:

• Individuals with a history of mental instability, drug/alcohol abuse within the past 5years or individuals who have been treated or are being treated for severe psychiatricillness which in the opinion of the Investigator, may interfere with optimalparticipation in the study.
• Underlying disease likely to limit life span to less than 1 year.
• Participants who have previously been randomized in any of the studies evaluatingezetimibe.
• Participants with known hypersensitivity or any contraindication to atorvastatin
• Pregnant or lactating women.
• Participants with congestive heart failure New York Heart Association (NYHA) Class IIIor IV.
• Participants with uncontrolled cardiac arrhythmias
• Participants with myocardial infarction, coronary bypass surgery or angioplasty within 3 months of study entry.
• Participants with unstable or severe peripheral artery disease within 3 months ofstudy entry.
• Participants with unstable angina pectoris.
• Participants with disorders of the hematologic, digestive or central nervous systemsincluding cerebrovascular disease and degenerative disease that would limit studyevaluation or participation.
• Participants with uncontrolled (as determined by hemoglobin A1c [HbA1c]) or newlydiagnosed (within 1 month of study entry) diabetes mellitus.
• Participants with uncontrolled endocrine or metabolic disease known to influence serumlipids or lipoproteins. Clinically euthyroid participants on replacement doses ofthyroid hormone are eligible for enrollment.
• Participants with known impairment of renal function (creatinine >2.0 mg/dL),dysproteinemia, nephrotic syndrome or other renal disease (24-hour urinary protein 3+or 1 gram).
• Participants with active or chronic hepatobiliary or hepatic disease (participantswith aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times theupper limit of the central laboratory reference range [ULN] will be excluded).
• Participants who are known to be human immunodeficiency virus (HIV) positive.
• Participants with known coagulopathy (prothrombin time [PT] or partial thromboplastintime [PTT] at Visit 2 >1.25 times control).