Status:
COMPLETED
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Primary Hypercholesterolemia
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00867165
Start Date
May 21 2009
End Date
April 13 2012
Last Update
May 21 2024
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