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

May 8, 2024 updated by: Organon and Co

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ezetimibe
Ezetimibe 10-mg tablet once daily for 12 weeks
Drug: ezetimibe
oral tablets: ezetimibe 10 mg once daily for 12 weeks
Other Names:
  • MK-0653
  • SCH 58235
  • Zetia
Placebo Comparator: Placebo
Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and 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).
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Total Cholesterol (TC) at Week 12
Time Frame: Baseline and Week 12
Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Time Frame: Baseline and Week 12
Serum Apo B measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame: Baseline and Week 12
Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in Non-HDL-C at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Percentage Change From Baseline in Triglycerides (TG) at Week 12
Time Frame: Baseline and Week 12
Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.
Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 2
Time Frame: Baseline and 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).
Baseline and Week 2
Percent Change From Baseline in LDL-C at Week 4
Time Frame: Baseline and 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).
Baseline and Week 4
Percent Change From Baseline in LDL-C at Week 8
Time Frame: Baseline and 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).
Baseline and Week 8
Percentage Change From Baseline in TC at Week 2
Time Frame: Baseline and Week 2
Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in TC at Week 4
Time Frame: Baseline and Week 4
Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in TC at Week 8
Time Frame: Baseline and Week 8
Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline HDL-C at Week 2
Time Frame: Baseline and Week 2
Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline HDL-C at Week 4
Time Frame: Baseline and Week 4
Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline HDL-C at Week 8
Time Frame: Baseline and Week 8
Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in Non-HDL-C at Week 2
Time Frame: Baseline and 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.
Baseline and Week 2
Percentage Change From Baseline in Non-HDL-C at Week 4
Time Frame: Baseline and 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.
Baseline and Week 4
Percentage Change From Baseline in Non-HDL-C at Week 8
Time Frame: Baseline and 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.
Baseline and Week 8
Percentage Change From Baseline in TG at Week 2
Time Frame: Baseline and Week 2
Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in TG at Week 4
Time Frame: Baseline and Week 4
Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in TG at Week 8
Time Frame: Baseline and Week 8
Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12
Time Frame: Baseline and Week 12
Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in TC:HDL-C Ratio at Week 2
Time Frame: Baseline and Week 2
Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in TC:HDL-C Ratio at Week 4
Time Frame: Baseline and Week 4
Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in TC:HDL-C Ratio at Week 8
Time Frame: Baseline and Week 8
Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in TC:HDL-C Ratio at Week 12
Time Frame: Baseline and Week 12
Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2
Time Frame: Baseline and Week 2
Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4
Time Frame: Baseline and Week 4
Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8
Time Frame: Baseline and Week 8
Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12
Time Frame: Baseline and Week 12
Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12
Time Frame: Baseline and Week 12
Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration
Baseline and Week 12
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4
Time Frame: Baseline and Week 4
Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12
Time Frame: Baseline and Week 12
Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percent Change From Baseline in Sitosterol at Week 2
Time Frame: Baseline and Week 2
Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in Sitosterol at Week 4
Time Frame: Baseline and Week 4
Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in Sitosterol at Week 8
Time Frame: Baseline and Week 8
Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in Sitosterol at Week 12
Time Frame: Baseline and Week 12
Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in Campesterol at Week 2
Time Frame: Baseline and Week 2
Plasma campesterol measured at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in Campesterol at Week 4
Time Frame: Baseline and Week 4
Plasma campesterol measured at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in Campesterol at Week 8
Time Frame: Baseline and Week 8
Plasma campesterol measured at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in Campesterol at Week 12
Time Frame: Baseline and Week 12
Plasma campesterol measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in Cholestanol at Week 2
Time Frame: Baseline and Week 2
Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in Cholestanol at Week 4
Time Frame: Baseline and Week 4
Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in Cholestanol at Week 8
Time Frame: Baseline and Week 8
Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in Cholestanol at Week 12
Time Frame: Baseline and Week 12
Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12
Percentage Change From Baseline in Lathosterol at Week 2
Time Frame: Baseline and Week 2
Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.
Baseline and Week 2
Percentage Change From Baseline in Lathosterol at Week 4
Time Frame: Baseline and Week 4
Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.
Baseline and Week 4
Percentage Change From Baseline in Lathosterol at Week 8
Time Frame: Baseline and Week 8
Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.
Baseline and Week 8
Percentage Change From Baseline in Lathosterol at Week 12
Time Frame: Baseline and Week 12
Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organon and Co

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P05522
  • 2008-006271-70 (EudraCT Number)
  • MK-0653-170 (Other Identifier: Merck Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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