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

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00867165

First received: March 20, 2009

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 20, 2009
Last Updated Date	April 26, 2012
Start Date ^ICMJE	May 2009
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 20, 2009)	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 [ Time Frame: 12 weeks after baseline measurement ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00867165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 20, 2009)	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 [ Time Frame: 12 weeks after baseline measurement ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (Study P05522)
Official Title ^ICMJE	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)
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Primary Hypercholesterolemia
Intervention ^ICMJE	Drug: ezetimibe oral tablets: ezetimibe 10 mg once daily for 12 weeks Other Names: SCH 58235 Zetia 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
Study Arm (s)	Experimental: ezetimibe Intervention: Drug: ezetimibe Placebo Comparator: placebo Intervention: Drug: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	138
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Years to 10 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00867165
Other Study ID Numbers ^ICMJE	P05522
Has Data Monitoring Committee	Yes
Responsible Party	Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Merck
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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