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

Sponsor:	Schering-Plough
Collaborator:	Merck
Information provided by (Responsible Party):	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00867165

Purpose

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.

Condition	Intervention	Phase
Primary Hypercholesterolemia	Drug: ezetimibe Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	135
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ezetimibe	Drug: ezetimibe oral tablets: ezetimibe 10 mg once daily for 12 weeks Other Names: SCH 58235 Zetia
Placebo Comparator: placebo	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

Eligibility

Ages Eligible for Study:	6 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00867165 History of Changes
Other Study ID Numbers:	P05522
Study First Received:	March 20, 2009
Last Updated:	December 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

heterozygous familial hypercholesterolemia
nonfamilial hypercholesterolemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012