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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00552097
First received: October 31, 2007
Last updated: April 24, 2014
Last verified: April 2014

October 31, 2007
April 24, 2014
June 2002
Not Provided
Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT00552097 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)
Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Subjects With Heterozygous Familial Hypercholesterolemia (The ENHANCE Trial)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Atherosclerosis
  • Hypercholesterolemia
  • Hyperlipoproteinemia Type II
  • 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
  • Drug: placebo (plus simvastatin)
    tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months
  • Experimental: EZ/Simva
    Intervention: Drug: ezetimibe (plus simvastatin)
  • Placebo Comparator: Placebo/Simva
    Intervention: Drug: placebo (plus simvastatin)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
April 2006
Not Provided

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00552097
P02578
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP