The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in participants with homozygous familial hypercholesterolemia (FH). Following completion of the 12-week, double-blind, efficacy and safety parent study (P01030/MK-0653-018; NCT03884452) participants will be offered entry into this open-label, 24-month extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
oral tablet
oral tablet
oral tablet
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 24 Months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time frame: Up to 24 Months
Mean Percent Change from Baseline in Low-density-lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and Month 24
Mean Percent Change from Baseline in Total Cholesterol (TC)
Time frame: Baseline and Month 24
Mean Percent Change from Baseline in High-density-lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and Month 24
Mean Percent Change from Baseline in Triglycerides (TG)
Time frame: Baseline and Month 24
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