Clinical Trial: Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: October 31, 2007
Date Started: June 1, 2002
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017
