The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children \>=6 to \<=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
oral tablets: ezetimibe 10 mg once daily for 12 weeks
oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol \[HDL-C\] + triglyceride \[TG\]/5).
Time frame: Baseline and Week 12
Percentage Change From Baseline in Total Cholesterol (TC) at Week 12
Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Serum Apo B measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Non-HDL-C at Week 12
Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Triglycerides (TG) at Week 12
Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.
Time frame: Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 2
Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol \[HDL-C\] + triglyceride \[TG\]/5).
Time frame: Baseline and Week 2
Percent Change From Baseline in LDL-C at Week 4
Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol \[HDL-C\] + triglyceride \[TG\]/5).
Time frame: Baseline and Week 4
Percent Change From Baseline in LDL-C at Week 8
Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol \[HDL-C\] + triglyceride \[TG\]/5).
Time frame: Baseline and Week 8
Percentage Change From Baseline in TC at Week 2
Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in TC at Week 4
Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in TC at Week 8
Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline HDL-C at Week 2
Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline HDL-C at Week 4
Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline HDL-C at Week 8
Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in Non-HDL-C at Week 2
Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Time frame: Baseline and Week 2
Percentage Change From Baseline in Non-HDL-C at Week 4
Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Time frame: Baseline and Week 4
Percentage Change From Baseline in Non-HDL-C at Week 8
Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Time frame: Baseline and Week 8
Percentage Change From Baseline in TG at Week 2
Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in TG at Week 4
Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in TG at Week 8
Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12
Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in TC:HDL-C Ratio at Week 2
Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in TC:HDL-C Ratio at Week 4
Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in TC:HDL-C Ratio at Week 8
Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in TC:HDL-C Ratio at Week 12
Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2
Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4
Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8
Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12
Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12
Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration
Time frame: Baseline and Week 12
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4
Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12
Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percent Change From Baseline in Sitosterol at Week 2
Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in Sitosterol at Week 4
Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in Sitosterol at Week 8
Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in Sitosterol at Week 12
Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Campesterol at Week 2
Plasma campesterol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in Campesterol at Week 4
Plasma campesterol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in Campesterol at Week 8
Plasma campesterol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in Campesterol at Week 12
Plasma campesterol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Cholestanol at Week 2
Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in Cholestanol at Week 4
Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in Cholestanol at Week 8
Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in Cholestanol at Week 12
Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Lathosterol at Week 2
Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.
Time frame: Baseline and Week 2
Percentage Change From Baseline in Lathosterol at Week 4
Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.
Time frame: Baseline and Week 4
Percentage Change From Baseline in Lathosterol at Week 8
Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.
Time frame: Baseline and Week 8
Percentage Change From Baseline in Lathosterol at Week 12
Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12
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