Overview

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

Status:
Completed
Trial end date:
2006-04-25
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Ezetimibe
Simvastatin
Criteria
Inclusion Criteria:

- Genotype-confirmed heterozygous familial hypercholesterolemia with written
documentation of the genetic diagnosis at the time of screening and LDL-C >=210 mg/dL
(5.43 mmol/L), or clinical diagnosis of heterozygous familial hypercholesterolemia,
defined as LDL-C >=210 mg/dL (5.43 mmol/L) and at least one of the following:

- tendinous xanthoma

- child <18 years of age with hypercholesterolemia (LDL-C >159 mg/dL (4.11 mmol/L)

- has a sibling with hypercholesterolemia (LDL-C >190 mg/dL [4.91 mmol/L]) and
tendinous xanthoma

- family history with an LDL-C value distribution pattern compatible with dominant
autosomal transmission and at least one relative presenting fasting total
cholesterol values >348 mg/dL (9.0 mmol/L) after exclusion of secondary causes of
dyslipidemia

- LDL-C >=210 mg/dL (5.43 mmol/L) 1 week before randomization

- plasma triglyceride level <=400 mg/dL (4.52 mmol/L)

Exclusion Criteria:

- pregnancy or any other situation, condition, or illness that, in the opinion of the
investigator, may interfere with optimal participation in the study

- presence of an apolipoprotein B gene mutation with confirmed absence of an LDL
receptor mutation in either allele

- undergoing LDL-apheresis or plasma apheresis

- unsuitable plaque or artery morphology

- use of certain drugs, foods, or other agents known to alter cholesterol levels or to
cause pharmacokinetic interactions with either ezetimibe or simvastatin