Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: ERN/LRPT; placebo
Intervention description: 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; ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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