Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (Study P05522)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Hypercholesterolemia
Intervention: ezetimibe (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: To determine the effect of ezetimibe 10 mg/day compared to placebo on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG) from baseline to 12 weeks of treatment
Eligibility
Minimum age: 6 Years.
Maximum age: 10 Years.
Gender(s): Both.
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Coordinating Location, Kenilworth, New Jersey 07033, United States; Recruiting
Additional Information
Starting date: May 2009
Ending date: January 2011
Last updated: September 16, 2009
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