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

NCT ID: NCT01414166

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-02-28

Brief 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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 for 16 weeks.

Group Type: EXPERIMENTAL

ERN/LRPT

Intervention Type: DRUG

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

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 placebo for 16 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

Interventions

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

Intervention Type: DRUG

placebo

ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Tredaptive™

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CTRI/2012/08/002873

Identifier Type: REGISTRY

Identifier Source: secondary_id

0524A-108

Identifier Type: -

Identifier Source: org_study_id