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

NCT00867165 | Completed Phase 3 Results DMC

• 3 other identifiers: P055222008-006271-70MK-0653-170
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hypercholesterolemia

Keywords

heterozygous familial hypercholesterolemia; nonfamilial hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and Week 12

Secondary Outcomes (48)

• Percentage Change From Baseline in Total Cholesterol (TC) at Week 12

  Baseline and Week 12

• Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12

  Baseline and Week 12

• Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12

  Baseline and Week 12

• Percentage Change From Baseline in Non-HDL-C at Week 12

  Baseline and Week 12

• Percentage Change From Baseline in Triglycerides (TG) at Week 12

  Baseline and Week 12

Study Arms (2)

Ezetimibe

EXPERIMENTAL

Ezetimibe 10-mg tablet once daily for 12 weeks

Drug: ezetimibe

Placebo

PLACEBO COMPARATOR

Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks

Drug: Placebo

Interventions

ezetimibe DRUG

oral tablets: ezetimibe 10 mg once daily for 12 weeks

Also known as: SCH 58235, MK-0653, Zetia

Ezetimibe

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• 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.

  PMID: 25841542 RESULT

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: May 21, 2009
• Primary Completion: April 13, 2012
• Study Completion: April 13, 2012
• Last Updated: May 21, 2024
• Results First Posted: May 30, 2013

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share