Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Phase 4
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00166504
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vytorin ezetimibe (+) simvastatin Ezetimibe 10 mg/Simvastatin 20 mg Atorvastatin atorvastatin Atorvastatin 10 mg
- Primary Outcome Measures
Name Time Method LDL-C Lowering Efficacy 6 weeks LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
- Secondary Outcome Measures
Name Time Method