Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)
NCT00552097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720
Last updated 2024-08-15
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.
Conditions
- Atherosclerosis
- Hypercholesterolemia
- Hyperlipoproteinemia Type II
Interventions
- DRUG
-
ezetimibe (plus simvastatin)
oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
- DRUG
-
placebo (plus simvastatin)
tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
Sponsors & Collaborators
- collaborator INDUSTRY
-
Organon and Co
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-06-01
- Primary Completion
- 2006-04-25
- Completion
- 2006-04-25
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