This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant \[ERN/LRPT (MK-0524A)\] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin, atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,173
1 oral 1 g tablet of ERN/LRPT to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of ERN/LRPT to be taken together in the evening or at bedtime with food for the next 8 weeks. Each 1g tablet contains 1g ERN and 20 mg LRPT
1 oral 1 g tablet of placebo to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of placebo to be taken together in the evening or at bedtime with food for the next 8 weeks.
Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline and Week 12
Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Triglyceride (TG) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apo A-I at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in TC at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in LDL-C:HDL-C at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in HDL-C at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in TG at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Non-HDL-C at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Apo B at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Apo B:Apo A-I at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in TC:HDL-C at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Lp(a) at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Apo A-I at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in TC at Week 4
Time frame: Baseline and Week 4
Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment
assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines
Time frame: Baseline and 12 weeks
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