Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)
Phase 4
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00157924
- Lead Sponsor
- Organon and Co
- Brief Summary
An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
- Clinical diagnosis of hypercholesterolemia
- Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal
Exclusion Criteria
- Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 simvastatin (+) ezetimibe 1. simvastatin/ezetimibe 10/20mg 2 atorvastatin 2. atorvastatin 10mg
- Primary Outcome Measures
Name Time Method LDL-C lowering efficacy 6 weeks
- Secondary Outcome Measures
Name Time Method Safety 6 weeks