Phase 3
Completed N=196
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
Source: ClinicalTrials.gov NCT00276458 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcomePrimary: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 — -30.8; -10.9 Percent — p=<0.001
Summary
The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 |
-30.8; -10.9 | <0.001 sig |
| SECONDARY Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6 |
3.2; 0.8 | 0.273 |
| SECONDARY Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 |
-26.7; -10.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total-Cholesterol at Week 6 |
-19.7; -7.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) at Week 6 |
-17.8; -5.5 | 0.159 |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 6 |
-21.4; -7.7 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 |
-20.6; -7.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 |
-31.9; -11.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6 |
-19.0; -5.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 |
-27.2; -9.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6 |
-6.7; -9.2 | 0.841 |
| SECONDARY Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6 |
77; 45; 15; 47 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg
Exclusion Criteria
- Pregnant or lactating women or intending to become pregnant
- Patient with sensitivity or intolerance to ezetimibe or atorvastatin
- Patient with diabetes or coronary heart disease
Data sourced from ClinicalTrials.gov (NCT00276458). 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.