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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00867165 |
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 |
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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) |
Estimated Enrollment: | 135 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ezetimibe: Experimental |
Drug: ezetimibe
oral tablets: ezetimibe 10 mg once daily for 12 weeks
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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
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Ages Eligible for Study: | 6 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Each subject must not:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05522 |
Study First Received: | March 20, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00867165 History of Changes |
Health Authority: | United States: Food and Drug Administration |
heterozygous familial hypercholesterolemia nonfamilial hypercholesterolemia |
Antimetabolites Metabolic Diseases Hyperlipidemias Antilipemic Agents Ezetimibe Anticholesteremic Agents |
Hypercholesterolemia, Autosomal Dominant Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Metabolic Diseases Hyperlipidemias Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Ezetimibe Anticholesteremic Agents Hypercholesterolemia Pharmacologic Actions Dyslipidemias Lipid Metabolism Disorders |