The overall objective is to evaluate the efficacy and safety of ezetimibe (SCH 058235/MK-0653) 10 mg administered daily in conjunction with atorvastatin in participants with Heterozygous Familial Hypercholesterolemia (HeFH) or in participants with coronary heart disease (CHD) or multiple cardiovascular risk factors (≥2 risk factors) and primary hypercholesterolemia not controlled by a starting dose (10 mg/day) of atorvastatin. The primary hypothesis is that the coadministration of ezetimibe 10 mg/day with atorvastatin therapy will result in a significantly greater proportion of participants achieving target low-density lipoprotein cholesterol (LDL-C) (≤100 mg/dL) when compared to the atorvastatin administered alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
621
Atorvastatin administered orally QD as 10 mg tablets.
Ezetimibe administered orally QD as 10 mg tablets
Single placebo tablet administered orally QD
Single placebo tablet administered orally QD
Percentage of Participants Achieving Target Low-Density-Lipoprotein Cholesterol (LDL-C) Levels of ≤100 mg/dL
The percentage of participants achieving the target low-density-lipoprotein cholesterol (LDL-C) levels (≤100 mg/dL \[2.59 mmol/L\]) as determined from blood samples following a standard ultracentrifugation/precipitation procedure (β-quantification).
Time frame: Week 14
Percentage of Participants With an Adverse Event
An adverse event (AE) is defined as any physical or clinical change or disease reported by a participant or observed by the investigator or member of the staff at any time during the study, regardless of potential relationship to study treatment, and included onset or discovery of new illness and exacerbation of any pre-existing condition.
Time frame: 14 weeks (Up to 16 weeks)
Percentage of Participants Who Discontinued the Study due to an Adverse Event
An adverse event (AE) is defined as any physical or clinical change or disease reported by a participant or observed by the investigator or member of the staff at any time during the study, regardless of potential relationship to study treatment, and included onset or discovery of new illness and exacerbation of any pre-existing condition.
Time frame: 14 weeks (Up to 16 weeks)
Percentage of Participants Achieving Target LDL-C level (≤100 mg/dL)
The percentage of participants achieving the target low-density-lipoprotein cholesterol (LDL-C) levels (≤100 mg/dL \[2.59 mmol/L\]) as determined from blood samples following a standard ultracentrifugation/precipitation procedure (β-quantification).
Time frame: Week 4
Mean Percent Change from Baseline in Direct LDL-C
Participants are to have their direct LDL-C levels assessed at baseline and after 4 weeks of study drug administration. The change from baseline will be calculated.
Time frame: Baseline and Week 4
Mean Percent Changes from Baseline for Calculated LDL-C
Participants are to have their calculated LDL-C levels assessed at baseline and after 4 weeks of study drug administration. The change from baseline will be calculated.
Time frame: Baseline and Week 4
Mean Percent Changes from Baseline for Total Cholesterol (TC)
Participants are to have their TC levels assessed at baseline and after 4 weeks of study drug administration. The change from baseline will be calculated.
Time frame: Baseline and Week 4
Mean Percent Changes from Baseline for Triglycerides (TG)
Participants are to have their TG levels assessed at baseline and after 4 weeks of study drug administration. The change from baseline will be calculated.
Time frame: Baseline and Week 4
Mean Percent Changes from Baseline for High-Density-Lipoprotein Cholesterol (HDL-C)
Participants hare to have their HDL-C levels assessed at baseline and after 4 weeks of study drug administration. The change from baseline will be calculated.
Time frame: Baseline and Week 4
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