NCT00166504CompletedPhase 4
A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 203
- Primary Endpoint
- LDL-C Lowering Efficacy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Vytorin
Experimental
Ezetimibe 10 mg/Simvastatin 20 mg
Intervention: ezetimibe (+) simvastatin (Drug)
Atorvastatin
Active Comparator
Atorvastatin 10 mg
Intervention: atorvastatin (Drug)
Outcomes
Primary Outcomes
LDL-C Lowering Efficacy
Time Frame: 6 weeks
LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
Secondary Outcomes
No secondary outcomes reported
Investigators
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