This study is being done to find out if tablets containing extended release (ER) niacin,
laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin
and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high
cholesterol and high lipid levels in the blood.
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Inclusion criteria
- Participant has a history of primary hypercholesterolemia or mixed dyslipidemia and
meets LDL-C and triglyceride criteria.
- Visit 2:
- Participant is high risk coronary heart disease (CHD) or CHD risk-equivalent.
Exclusion Criteria
- Participant is pregnant or breast-feeding, or expecting to conceive during the study.
- Participant has a history of malignancy.
- Participant consumes more than 3 alcoholic drinks per day (14 per week).
- Participant is high risk CHD patient on statin therapy or any patient on statin
therapy equivalent to 80 mg simvastatin.
- Participant with Type 1 or Type 2 diabetes mellitus that is poorly controlled, or on
statin therapy.
- Participant currently engages in vigorous exercise or is on an aggressive diet
regimen.
- Participant uncontrolled endocrine or metabolic disease, uncontrolled gout, kidney or
hepatic disease, heart failure, recent peptic ulcer disease, hypersensitivity or
allergic reaction to niacin or simvastatin, recent heart attack, stroke or heart
surgery.
- Participant is human immunodeficiency virus (HIV) positive.
- Participant has taken niacin >50 mg/day, bile-acid sequestrants, HMG-CoA reductase
inhibitors, ezetimibe, Cholestin™ [red yeast rice] and other red yeast products
within 6 weeks, or fibrates within 8 weeks of randomization visit (Visit 3).
- Note: Fish oils, phytosterol margarines and other non-prescribed therapies are
allowed provided participant has been on a stable dose for 6 weeks prior to
Visit 2 and agrees to remain on this dose for the duration of the study.
- Participant is currently receiving cyclical hormonal contraceptives or intermittent
use of hormone replacement therapies (HRTs) (e. g., estradiol, medroxyprogesterone,
progesterone).
- Note: Participants who have been on a stable dose of non-cyclical HRT or
hormonal contraceptive for greater than 6 weeks prior to Visit 1 are eligible if
they agree to remain on the same regimen for the duration of the study.
- Participant is taking prohibited medications such as systemic corticosteroids,
itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin,
nefazodone, HIV protease inhibitors, verapamil, amiodarone, cyclosporine, danazol,
diltiazem or fusidic acid.
- Patient consumes >1 quart of grapefruit juice/day.