Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)

Inclusion Criteria

• Subjects must be >=18 years and 3.64 mmol/L (140 mg/dL) to 5.2 mmol/L (200 mg/dL) to =30 kg/m2 at Visit 3 (Baseline Visit).
• Subjects who have known hypersensitivity to HMG CoA reductase inhibitors.
• 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.
• Congestive heart failure defined by NYHA as Class III or IV.
• Uncontrolled cardiac arrhythmia.
• Myocardial infarction, coronary bypass surgery, or angioplasty within 6 months of study entry.
• Unstable or severe peripheral artery disease within 3 months of study entry.
• Unstable angina pectoris within 6 months of study entry.
• Uncontrolled hypertension (treated or untreated) with systolic blood pressure >160 mm Hg or diastolic >100 mm Hg at study entry.
• Uncontrolled (as determined by fasting glucose >180 mg/mL or HbA1c >9%) or newly diagnosed (within 1 month of study entry) diabetes mellitus.
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ie, secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to hypothyroidism (thyroid stimulating hormone [TSH] above upper limit of normal). 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 TSH levels are within normal limits before enrollment.
• Known impaired renal function (plasma creatinine >2.0 mg/dL), or nephrotic syndrome at study entry.
• Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
• Known 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.
• Female subject receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives.