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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
244
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
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
Time frame: Baseline and Weeks 12 to 16
Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16
The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in HDL-C at Week 16
The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in Triglycerides (TG) at Week 16
The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in Non-HDL-C at Week 16
The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16
The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16
The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16
The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
Time frame: Baseline and Week 16
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