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Sponsors and Collaborators: |
Schering-Plough Merck |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00651391 |
The purpose of this study is to evaluate the effect of ezetimibe coadministered with simvastatin compared with simvastatin alone when administered for 12 weeks on endothelial function as assessed by brachial artery reactivity testing (BART) using high-frequency ultrasound to image the brachial artery vasomotor response to a flow-mediated stimulus (high-shear stress) in subjects with high cholesterol. The secondary objectives include evaluation of nitroglycerin-induced vasodilation. In addition, lipid parameters (low-density-lipoprotein cholesterol [LDL-C], high-density-lipoprotein cholesterol [HDL-C], triglycerides [TG], total cholesterol [TC]) and C reactive protein (CRP) will be assessed by treatment group.
Condition | Intervention | Phase |
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Hypercholesterolemia Atherosclerosis |
Drug: Ezetimibe + Simvastatin Drug: Simvastatin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Ezetimibe Plus Simvastatin Compared With Simvastatin Alone on Flow-Mediated Brachial Artery Vasoactivity in Subjects With Primary Hypercholesterolemia (The EFFECTS Trial) |
Enrollment: | 28 |
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 tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily in the evening for 12 weeks
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Simvastatin: Active Comparator |
Drug: Simvastatin
oral simvastatin 20 mg once daily in the evening for 12 weeks
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Placebo: Placebo Comparator |
Drug: Placebo
oral placebo once daily in the evening 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: | P03336 |
Study First Received: | March 31, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00651391 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Atherosclerosis Metabolic Diseases Hyperlipidemias Simvastatin Vascular Diseases |
Ezetimibe Arteriosclerosis Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |