Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Overview

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Full Title of Study: “A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: ezetimibe (+) simvastatin
    • simvastatin/ezetimibe 10/20 mg
  • Drug: atorvastatin
    • atorvastatin 10 mg

Arms, Groups and Cohorts

  • Experimental: Vytorin
    • Ezetimibe 10 mg/Simvastatin 20 mg
  • Active Comparator: Atorvastatin
    • Atorvastatin 10 mg

Clinical Trial Outcome Measures

Primary Measures

  • LDL-C Lowering Efficacy
    • Time Frame: 6 weeks
    • LDL-C = low density lipoprotein cholesterol, measured in mg/dl.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of hypercholesterolemia – LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL – National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline Exclusion Criteria:

  • Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

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