Clinical trial NCT01414166: Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Official title: A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
timeFrame: Baseline and Weeks 12 to 16
Secondary outcomes:
measure: Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in HDL-C at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Triglycerides (TG) at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Non-HDL-C at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
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