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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00651404 |
To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of treatment.
Condition | Intervention | Phase |
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Hypercholesterolemia Atherosclerosis |
Drug: Ezetimibe Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-Administration Of Ezetimibe 10 mg Or Ezetimibe Placebo To Ongoing Treatment With Atorvastatin 10 mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease. |
Enrollment: | 137 |
Study Start Date: | January 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ezetimibe: Experimental |
Drug: Ezetimibe
oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
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Placebo: Placebo Comparator |
Drug: Placebo
oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
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Ages Eligible for Study: | 18 Years to 75 Years |
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: | P03406 |
Study First Received: | March 31, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00651404 History of Changes |
Health Authority: | Hungary: National Institute of Pharmacy |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Antilipemic Agents Vascular Diseases Ezetimibe Anticholesteremic Agents |
Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Hypercholesterolemia Metabolic Disorder Atorvastatin Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Vascular Diseases Enzyme Inhibitors Ezetimibe |
Arteriosclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |