Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ezetimibe
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia focused on measuring heterozygous familial hypercholesterolemia, nonfamilial hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of >159mg/dL
- Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
Exclusion Criteria:
Each subject must not:
- Have known hypersensitivity or any contraindication to ezetimibe.
- Have use of any investigational drugs within 30 days of study entry.
- Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
- Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
- Have known congenital cardiac disorder.
- Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
- Be known to be human immunodeficiency virus (HIV) positive.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ezetimibe
Placebo
Arm Description
Ezetimibe 10-mg tablet once daily for 12 weeks
Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Percent Change From Baseline in Sitosterol at Week 2
Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.
Percentage Change From Baseline in Sitosterol at Week 4
Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.
Percentage Change From Baseline in Sitosterol at Week 8
Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.
Percentage Change From Baseline in Sitosterol at Week 12
Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.
Percentage Change From Baseline in Campesterol at Week 2
Plasma campesterol measured at baseline and after 2 weeks of study drug administration.
Percentage Change From Baseline in Campesterol at Week 4
Plasma campesterol measured at baseline and after 4 weeks of study drug administration.
Percentage Change From Baseline in Campesterol at Week 8
Plasma campesterol measured at baseline and after 8 weeks of study drug administration.
Percentage Change From Baseline in Campesterol at Week 12
Plasma campesterol measured at baseline and after 12 weeks of study drug administration.
Percentage Change From Baseline in Cholestanol at Week 2
Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.
Percentage Change From Baseline in Cholestanol at Week 4
Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.
Percentage Change From Baseline in Cholestanol at Week 8
Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.
Percentage Change From Baseline in Cholestanol at Week 12
Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.
Percentage Change From Baseline in Lathosterol at Week 2
Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.
Percentage Change From Baseline in Lathosterol at Week 4
Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.
Percentage Change From Baseline in Lathosterol at Week 8
Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.
Percentage Change From Baseline in Lathosterol at Week 12
Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.
Full Information
NCT ID
NCT00867165
First Posted
March 20, 2009
Last Updated
February 7, 2022
Sponsor
Organon and Co
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00867165
Brief Title
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) (Phase 3, Protocol No. P05522)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2009 (Actual)
Primary Completion Date
April 13, 2012 (Actual)
Study Completion Date
April 13, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
Keywords
heterozygous familial hypercholesterolemia, nonfamilial hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ezetimibe
Arm Type
Experimental
Arm Description
Ezetimibe 10-mg tablet once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Other Intervention Name(s)
SCH 58235, MK-0653, Zetia
Intervention Description
oral tablets: ezetimibe 10 mg once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
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
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in Total Cholesterol (TC) at Week 12
Description
Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Description
Serum Apo B measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Description
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
Title
Percentage Change From Baseline in Non-HDL-C at Week 12
Description
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
Title
Percentage Change From Baseline in Triglycerides (TG) at Week 12
Description
Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in LDL-C at Week 2
Description
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
Title
Percent Change From Baseline in LDL-C at Week 4
Description
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
Title
Percent Change From Baseline in LDL-C at Week 8
Description
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
Title
Percentage Change From Baseline in TC at Week 2
Description
Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in TC at Week 4
Description
Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in TC at Week 8
Description
Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline HDL-C at Week 2
Description
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
Title
Percentage Change From Baseline HDL-C at Week 4
Description
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
Title
Percentage Change From Baseline HDL-C at Week 8
Description
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
Title
Percentage Change From Baseline in Non-HDL-C at Week 2
Description
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
Title
Percentage Change From Baseline in Non-HDL-C at Week 4
Description
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
Title
Percentage Change From Baseline in Non-HDL-C at Week 8
Description
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
Title
Percentage Change From Baseline in TG at Week 2
Description
Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in TG at Week 4
Description
Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in TG at Week 8
Description
Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12
Description
Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in TC:HDL-C Ratio at Week 2
Description
Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in TC:HDL-C Ratio at Week 4
Description
Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in TC:HDL-C Ratio at Week 8
Description
Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in TC:HDL-C Ratio at Week 12
Description
Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2
Description
Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4
Description
Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8
Description
Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12
Description
Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12
Description
Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4
Description
Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12
Description
Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Sitosterol at Week 2
Description
Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in Sitosterol at Week 4
Description
Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in Sitosterol at Week 8
Description
Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in Sitosterol at Week 12
Description
Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in Campesterol at Week 2
Description
Plasma campesterol measured at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in Campesterol at Week 4
Description
Plasma campesterol measured at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in Campesterol at Week 8
Description
Plasma campesterol measured at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in Campesterol at Week 12
Description
Plasma campesterol measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in Cholestanol at Week 2
Description
Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in Cholestanol at Week 4
Description
Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in Cholestanol at Week 8
Description
Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in Cholestanol at Week 12
Description
Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
Title
Percentage Change From Baseline in Lathosterol at Week 2
Description
Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.
Time Frame
Baseline and Week 2
Title
Percentage Change From Baseline in Lathosterol at Week 4
Description
Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.
Time Frame
Baseline and Week 4
Title
Percentage Change From Baseline in Lathosterol at Week 8
Description
Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.
Time Frame
Baseline and Week 8
Title
Percentage Change From Baseline in Lathosterol at Week 12
Description
Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of >159mg/dL
Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
Exclusion Criteria:
Each subject must not:
Have known hypersensitivity or any contraindication to ezetimibe.
Have use of any investigational drugs within 30 days of study entry.
Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
Have known congenital cardiac disorder.
Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
Be known to be human immunodeficiency virus (HIV) positive.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
25841542
Citation
Kusters DM, Caceres M, Coll M, Cuffie C, Gagne C, Jacobson MS, Kwiterovich PO, Lee R, Lowe RS, Massaad R, McCrindle BW, Musliner TA, Triscari J, Kastelein JJ. Efficacy and safety of ezetimibe monotherapy in children with heterozygous familial or nonfamilial hypercholesterolemia. J Pediatr. 2015 Jun;166(6):1377-84.e1-3. doi: 10.1016/j.jpeds.2015.02.043. Epub 2015 Apr 1.
Results Reference
result
Learn more about this trial
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
We'll reach out to this number within 24 hrs