Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

Exclusion Criteria

• •Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
• •Uncontrolled hypertension \>180/95 at screening
• •Hx of chronic renal insufficiency (serum creatinine \> 2.5 mg/dL)
• •Hx of liver disease or transaminases \> 1.5 X ULN
• •Positive for Hepatitis B or C
• •Major surgery within past 3 mos
• •Cardiac insufficiency defined as functional Class II-Class IV
• •Hx of malignancy within previous 5 years
• •Participation in another investigational drug study within past 6 wks
• •Serious or unstable medical or psychological condition
• •Regular alcohol use \> 1 drink per day
• •Regular consumers of grapefruit juice or medications known to be metabolized by CYP 3A4
• •Use of other lipid-lowering meds (washout permitted)
• •Acute CVD
• •Diabetes Mellitus
• •Fasting glucose \>110 mg/dL
• •BMI -/\> 40 kg/m2
• •Significant gastrointestinal symptoms such as IBS
• •Use of fish oils, niacin, herbal wt. loss products (washout permitted)