Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578) "ENHANCE"

Completed

Phase 3 Results

Trial Description

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

Interventions

  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
  • Ezetimibe (Zetia)Drug
    Intervention Desc: Ezetimibe (pronounced /ɛˈzɛtəmɪb/) is an anti-hyperlipidemic medication which is used to lower cholesterol levels. It acts by decreasing cholesterol absorption in the intestine. It may be used alone when other cholesterol-lowering medications are not tolerated, or together with statins (e.g. ezetimibe/simvastatin, marketed as Vytorin and Inegy) when cholesterol levels are unable to be controlled on statins alone.
  • Ezetimibe (plus simvastatin) Drug
    Other Names: ZETIA; VYTORIN; SCH 58235; SCH 465981
    Intervention Desc: oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
    ARM 1: Kind: Experimental
    Label: EZ/Simva
  • Placebo (plus simvastatin) Drug
    Intervention Desc: tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
    ARM 1: Kind: Experimental
    Label: Placebo/Simva

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: 1)ezetimibe (plus simvastatin) oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months or 2) placebo (plus simvastatin) tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint.
Secondary Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint; change in ultrasound-determined maximum carotid artery IMT on a per subject basis between baseline and endpoint; proportion of subjects developing new carotid artery plaques between baseline and endpoint; change in ultrasound-determined average carotid artery plus average common femoral artery IMT on a per subject basis between baseline and endpoint.
Secondary Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint. 24 months
Secondary Change in ultrasound-determined maximum carotid artery IMT on a per subject basis between baseline and endpoint. 24 months
Secondary Proportion of subjects developing new carotid artery plaques between baseline and endpoint. 24 months
Secondary Change in ultrasound-determined average carotid artery plus average common femoral artery IMT on a per subject basis between baseline and endpoint. 24 months

Sponsors