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| Descriptive Information Fields | |||||
| Brief Title † | Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578AM3)(COMPLETED) | ||||
| Official Title † | Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Subjects With Heterozygous Familial Hypercholesterolemia (The ENHANCE Trial) | ||||
| Brief Summary | The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ] | ||||
| Secondary Outcome Measure † | Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint. [ Time Frame: 24 months ] Change in ultrasound-determined maximum carotid artery IMT on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ] Proportion of subjects developing new carotid artery plaques between baseline and endpoint. [ Time Frame: 24 months ] Change in ultrasound-determined average carotid artery plus average common femoral artery IMT on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ] |
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| Condition † | Atherosclerosis Hypercholesterolemia Hyperlipoproteinemia Type II |
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| Intervention † | Drug: ezetimibe (plus simvastatin) Drug: placebo (plus simvastatin) |
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| MEDLINE PMIDs | 15846260 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 720 | ||||
| Start Date † | June 2002 | ||||
| Completion Date | April 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00552097 | ||||
| Organization ID | P02578 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Schering-Plough | ||||
| Collaborators †† | Merck | ||||
| Investigators † |
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| Information Provided By | Schering-Plough | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | October 31, 2007 | ||||
| Last Updated Date | June 19, 2008 | ||||