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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
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia focused on measuring heterozygous familial hypercholesterolemia, nonfamilial hypercholesterolemia

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 20, 2009
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    Collaborators
    Merck Sharp & Dohme LLC
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    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

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    Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)

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