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

Organon

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: Placebo; Drug: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867165

2008-006271-70 (EudraCT Number)

MK-0653-170 (Other Identifier)

P05522

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

Ezetimibe

Experimental group

Description:

Ezetimibe 10-mg tablet once daily for 12 weeks

Treatment:

Drug: ezetimibe

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo