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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00552097
First received: October 31, 2007
Last updated: June 19, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Hypercholesterolemia
Hyperlipoproteinemia Type II
 Drug: ezetimibe (plus simvastatin)
Drug: placebo (plus simvastatin)
 Phase 3

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
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 720
Study Start Date: June 2002
Study Completion Date: April 2006
Arms Assigned Interventions
Experimental: EZ/Simva Drug: ezetimibe (plus simvastatin)
oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
Other Names:
  • ZETIA
  • VYTORIN
  • SCH 58235
  • SCH 465981
Placebo Comparator: Placebo/Simva Drug: placebo (plus simvastatin)
tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552097

Sponsors and Collaborators
Schering-Plough
Merck
Investigators
Study Director: Enrico P. Veltri, MD Schering-Plough
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00552097     History of Changes
Other Study ID Numbers: P02578
Study First Received: October 31, 2007
Last Updated: June 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipoproteinemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
 Metabolism, Inborn Errors
Genetic Diseases, Inborn
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013