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Trial record 1 of 1 for:    NCT00552097
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Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578) (ENHANCE)

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ClinicalTrials.gov Identifier: NCT00552097
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : February 17, 2022
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Organon and Co

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Actual Study Start Date : June 1, 2002
Actual Primary Completion Date : April 25, 2006
Actual Study Completion Date : April 25, 2006

Arm Intervention/treatment
Experimental: EZ/Simva Drug: ezetimibe (plus simvastatin)
oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
Other Names:
  • 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

Primary Outcome Measures :
  1. 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 :
  1. Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint. [ Time Frame: 24 months ]
  2. Change in ultrasound-determined maximum carotid artery IMT on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ]
  3. Proportion of subjects developing new carotid artery plaques between baseline and endpoint. [ Time Frame: 24 months ]
  4. 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 ]

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00552097    
Other Study ID Numbers: P02578
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors