Phase 3
Completed N=579
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
Source: ClinicalTrials.gov NCT00276484 ↗Enrolled (actual)
579
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C — -27.4; -11.0 Percent Change — p=<0.001
Summary
To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C |
-27.4; -11.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) |
-0.5; -1.0 | 0.551 |
| SECONDARY Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) |
-23.3; -9.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Total-Cholesterol |
-16.9; -6.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Triglycerides (TG) |
-12.3; -5.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) |
-17.8; -7.7 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) |
-0.3; -1.2 | 0.313 |
| SECONDARY Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio |
-16.0; -5.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio |
-26.4; -9.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio |
-16.9; -5.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio |
-22.2; -7.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) |
-18.3; -11.5 | 0.174 |
| SECONDARY Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 |
204; 88; 73; 191 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg
Exclusion Criteria
- Pregnant or lactating women or intending to become pregnant
- Patient with sensitivity or intolerance to ezetimibe or atorvastatin
Data sourced from ClinicalTrials.gov (NCT00276484). 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.