Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (Protocol MK-0524A-133 AM2)

Inclusion Criteria:

- Has a history of primary hypercholesterolemia or mixed dyslipidemia.

- Must meet one of the risk categories (very high, high or moderate and corresponding
LDL-C criteria at Visit 2.

- Has TG levels <500 mg/dL (<5.65 mmol/L).

- Has been on a stable dose of one of the following lipid-modifying therapies (LMTs)for
at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of
LMT for the duration of the study:

- Monotherapy: any statin

- Combination Therapy: ezetimibe/simvastatin in the same tablet

- Co-administration Therapy: any statin co-administered with ezetimibe

- Is male or female and ≥18 years of age on day of signing informed consent.

- A female must meet ONE of the following:

- Of reproductive potential and agrees to remain abstinent or use (or have their
partner use) 2 acceptable methods of birth control for the study duration.

- Not of reproductive potential is eligible without requiring the use of
contraception. Definition of "not of reproductive potential": one who has either
of the following:

- reached natural menopause, defined as: 6 months of spontaneous amenorrhea
with serum FSH levels (at Visit 1) in the postmenopausal range (per central
lab) or 12 months of spontaneous amenorrhea.Spontaneous amenorrhea does not
include cases for which there is an underlying disease that causes
amenorrhea (e.g., anorexia nervosa).

- 6 weeks post surgical hysterectomy, or bilateral oophorectomy with or
without hysterectomy.

- Bilateral tubal ligation without subsequent restorative procedure.

- Understands the study's procedures, alternative treatments available, risks involved
with the study, and voluntarily agrees to participate by giving written informed
consent.

Exclusion Criteria

- Has taken a prohibited LMT within 6 weeks of Visit 1. Examples of prohibited LMT
include bile acid sequestrants, fibrates (monotherapy, coadministration or
combination with other LMT), niacin >50 mg, and red yeast rice products.

- Has had a change to the type or dose of acceptable LMT regimen within 6 weeks of
Visit 1.

- Is pregnant, breastfeeding, or expecting to conceive during the study including the
14-day poststudy follow-up.

- Has a history of malignancy ≤5 years prior to signing informed consent, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical
cancer.

- Female who is expecting to donate eggs during the study, including the 14-day
follow-up.

- Is unlikely to adhere to the study procedures, keep appointments, or is planning to
relocate during the study.

- Has participated in a study, including post-study follow-up, with an investigational
compound (non-lipid-modifying) within 30 days of Visit 1 or a lipid-modifying
compound (investigational or marketed), within 6 weeks of Visit 1.

- Has donated and/or received blood as follows:

- donated blood products or has had phlebotomy of >300 mL within 8 weeks prior to
signing informed consent.

- intends to give or receive blood products during the study.

- intends to donate more than 250 mL of blood products within 8 weeks following
the last study visit.

- Has the following exclusionary laboratory values at Visit 2

- Creatinine clearance (eGFR) <30 mL/min (0.50 mL/s)

- ALT (SGPT) >1.5 x ULN

- AST (SGOT) >1.5 x ULN

- CK >2 x ULN

- Has used recreational or illicit drugs within 1 year of signing informed consent.

- Was <80% compliant with LMT or placebo at Visit 2, AND in the opinion of the
investigator, is believed to be unable to maintain at least 80% compliance with
dosing during the active treatment period.

- Has chronic heart failure defined by the New York Heart Association (NYHA) Classes
III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension
(systolic blood pressure >160 mm Hg or diastolic >100 mm Hg).

- Has Type 1 or Type 2 diabetes mellitus and meets one or more of the following
criteria:

- Is poorly controlled (HbA1C >8.0% at Visit 1)

- Is newly diagnosed (within 3 months of Visit 1)

- Has recently experienced repeated hypoglycemia or unstable glycemic control
(within 3 months of Visit 1).

- Is taking new or recently adjusted antidiabetic pharmacotherapy (with the
exception of ± ≤ 10 units of insulin) within 3 months of Visit 1.

- Has uncontrolled endocrine or metabolic disease known to influence serum lipids or
lipoproteins (i.e., secondary causes of hyperlipidemia such as hyper- or
hypothyroidism.

- Has nephrotic syndrome or other clinically significant renal disease.

- Has active peptic ulcer disease within 3 months of Visit 1.

- Has a history of hypersensitivity or allergic reaction to niacin or niacin containing
products.

- Has history of myocardial infarction, stroke, coronary artery bypass surgery or other
revascularization procedure, unstable angina or angioplasty within 3 months of Visit
1.

- Has arterial bleeding.

- Has a history of ileal bypass, gastric bypass or other significant condition
associated with malabsorption or rapid weight loss within 18 months of Visit 1.

- Has active or chronic hepatobiliary or hepatic disease.

- Is Chinese and is on simvastatin 80 mg or a product containing simvastatin 80 mg at
Visit 1.

- Is receiving treatment with systemic steroids (intravenous, injected, and oral
steroids) OR systemic anabolic agents.

- Consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per
week.

- Is taking the following antioxidant vitamins each day:

- Vitamin C in excess of 1500 mg

- Vitamin E in excess of 45 IU for men, 36 IU for women

- Beta Carotene 15000 IU for men, 12000 IU for women