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:	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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ezetimibe: Experimental	Drug: ezetimibe oral tablets: ezetimibe 10 mg once daily for 12 weeks
placebo: Placebo Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867165

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, California
Investigational Site 12	Recruiting
Los Angeles, California, United States, 90036
United States, Maryland
Investigational Site 18	Recruiting
Baltimore, Maryland, United States, 21287
United States, New York
Investigational Site 22	Recruiting
Great Neck, New York, United States, 11021
United States, Ohio
Investigational Site 11	Recruiting
Cincinnati, Ohio, United States, 45212
United States, Oregon
Investigational Site 23	Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Investigational Site 13	Recruiting
Wexford, Pennsylvania, United States, 15090
Canada
Investigational Site 14	Recruiting
Winnipeg, Canada, R3A 1R9
Investigational Site 16	Recruiting
Quebec, Canada, G1V 4M6
Investigational Site 17	Recruiting
Chicoutimi, Canada, G7H 5H6
Investigational Site 15	Recruiting
Toronto, Canada, M5G 1X8
Investigational Site 19	Recruiting
Sherbrooke, Canada, J1H 5N4
Investigational Site 20	Recruiting
Montreal, Canada, H3H 1P3
Colombia
Investigational Site 5	Recruiting
Barranquilla, Colombia
Investigational Site 6	Recruiting
Medellin, Colombia
Investigational Site 7	Recruiting
Bogota, Colombia
Investigational Site 8	Recruiting
Medellin, Colombia
Investigational Site 4	Recruiting
Bogota, Colombia
France
Investigational Site 3	Recruiting
Vandoeuvre-les-Nancy, France, 54500
Investigational Site 21	Recruiting
Toulouse Cedex 09, France, 31059
Norway
Investigational Site 2	Recruiting
Oslo, Norway, 0027

Sponsors and Collaborators

Schering-Plough

Merck

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05522
Study First Received:	March 20, 2009
Last Updated:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00867165 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

heterozygous familial hypercholesterolemia
nonfamilial hypercholesterolemia

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Ezetimibe
Anticholesteremic Agents
Hypercholesterolemia
Pharmacologic Actions
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010