MK-0524B Lipid Study (MK-0524B-063)

A Multicenter, Randomized, Double-Blind, "Crossover" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK-0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia

This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.

Inclusion Criteria:

• has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit

• meets one of the following triglyceride (TG) criteria:

  1. is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of washout
  2. is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of screening

Exclusion Criteria:

• is high risk (coronary heart disease [CHD] or CHD risk equivalent) AND is on a statin
• is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
• has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
• has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)