Niacin/Laropiprant Tablet for South and Southeast Asians With Low HDL at Risk for Cardiovascular Disease (MK-0524A-108 AM1)

• Change from baseline in ratio of LDL-C to HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Change from baseline in HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Change from baseline in TG [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Percent change from baseline in non-HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Percent change from baseline in ratio of total cholesterol (TC) to HDL-C [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Percent change from baseline in lipoprotein(a) (Lp[a]) [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Percent change from baseline in apolipoprotein B (Apo B) [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
• Percent change from baseline in apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]

The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.

• Drug: ERN/LRPT
  ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
  Other Name: Tredaptive™
• Drug: placebo
  ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

• Experimental: ERN/LRPT group
  All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT or placebo for 16 weeks
  Intervention: Drug: ERN/LRPT
• Placebo Comparator: Placebo group
  All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT or placebo for 16 weeks
  Intervention: Drug: placebo

Inclusion criteria:

• LMT ineligible
• Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
• HDL-C <40 mg/dL (1.03 mmol/L) in males and <50 mg/dL (1.29 mmol/L) in females
• Triglyceride (TG) level <300 mg/dL (3.39 mmol/L).
• Fasting serum glucose (FSG) at Visit 1 AND Visit 2 <126 mg/dL (<7 mmol/L)
• Hemoglobin A1c (HbA1c) level <6.5%
• Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period

Exclusion criteria:

• 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
• Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
• Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
• Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
• Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study
• Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%
• Risk factors for coronary heart disease
• Active or chronic hepatobiliary or hepatic disease
• Active peptic ulcer disease within 3 months of Visit 1
• History of hypersensitivity or allergic reaction to niacin or niacin-containing products
• Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol
• Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin >50 mg as monotherapy or coadministered with other LMTs)
• Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering
• Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)
• Uncontrolled illness or infection