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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