Phase 4
Completed N=203
Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Source: ClinicalTrials.gov NCT00166504 ↗Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Nov 2008
Primary outcomePrimary: LDL-C Lowering Efficacy — -51; -41 Percent Change from Baseline — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL-C Lowering Efficacy |
-51; -41 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00166504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.