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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Dyslipidemia

Treatments: Drug: placebo; Drug: ERN/LRPT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01414166

CTRI/2012/08/002873 (Registry Identifier)

0524A-108

Details and patient eligibility

About

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.

Enrollment: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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244 participants in 2 patient groups, including a placebo group

ERN/LRPT group

Experimental group

Description:

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 for 16 weeks.

Treatment:

Drug: ERN/LRPT

Placebo group

Placebo Comparator group

Description:

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 placebo for 16 weeks.

Treatment:

Drug: placebo