Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Niacin

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