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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00650663 |
The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in African-American subjects with primary hypercholesterolemia. This study is being performed to better define the efficacy of ezetimibe coadministered with simvastatin in this population.
Condition | Intervention | Phase |
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Hypercholesterolemia Atherosclerosis |
Drug: Ezetimibe + Simvastatin Drug: Simvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized Study to Evaluate the Lipid-Altering Efficacy, Safety, and Tolerability of Ezetimibe Coadministered With Simvastatin Versus Simvastatin Monotherapy in African-American Subjects With Primary Hypercholesterolemia |
Enrollment: | 247 |
Study Start Date: | October 2003 |
Study Completion Date: | September 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ezetimibe + Simvastatin: Experimental |
Drug: Ezetimibe + Simvastatin
oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks
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Simvastatin: Active Comparator |
Drug: Simvastatin
oral tablet; simvastatin 20 mg once daily for 12 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P03377 |
Study First Received: | March 31, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650663 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Simvastatin Antilipemic Agents Vascular Diseases |
Ezetimibe Anticholesteremic Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Vascular Diseases Enzyme Inhibitors |
Ezetimibe Anticholesteremic Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |