Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578AM3)(COMPLETED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00552097
• Date of registration: 31/10/2007
• Primary sponsor: Schering-Plough
• Public title: Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578AM3)(COMPLETED) ENHANCE
• Scientific 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)
• Date of first enrolment: June 2002
• Target sample size: 720
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00552097
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Contacts

• Name: Enrico P. Veltri, MD
• Affiliation: Schering-Plough

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Atherosclerosis

Hypercholesterolemia

Hyperlipoproteinemia Type II

Intervention(s)

Drug: ezetimibe (plus simvastatin)

Drug: placebo (plus simvastatin)

Primary Outcome(s)

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(s)

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]

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]

Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint. [Time Frame: 24 months]

Secondary ID(s)

P02578

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck