A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
Condition: Primary Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Simvastatin; Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM); Extended Release (ER) niacin/laropiprant (N/LRPT); Placebo
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 977.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Low-density lipoprotein; LDL; High-density lipoprotein; HDL; Niacin; Lipid modifying therapy; Cholesterol; High cholesterol; Triglycerides; Mixed Dyslipidemia

Summary:

      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. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is
      equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density
      lipoprotein cholesterol (LDL-C).
    

Eligibility criteria:

        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, hydroxymethyl
             glutaryl coenzyme A (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.

          -  Participant consumes >1 quart of grapefruit juice/day.