Phase 3
Completed N=1,289
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
Source: ClinicalTrials.gov NCT00535405 ↗Enrolled (actual)
1,289
Serious AEs
1.8%
Results posted
May 2010
Primary outcomePrimary: Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 — -39.5; -54.2; -46.6; -59.1 Percent change in LDL-C — p=<0.001
Summary
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 |
-39.5; -54.2; -46.6; -59.1; -50.8 | <0.001 sig |
| SECONDARY Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 |
9.9; 51.3; 26.1; 68.2; 38.1 | <0.001 sig |
| SECONDARY Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 |
45.0; 69.0; 61.3; 82.1; 69.9 | <0.001 sig |
| SECONDARY Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 |
58.7; 83.6; 76.9; 90.3; 79.5 | <0.001 sig |
| SECONDARY Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 |
10.9; 54.3; 28.9; 69.2; 38.2 | <0.001 sig |
| SECONDARY Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 |
10.0; 44.4; 31.6; 65.8; 44.4 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has a cholesterol level of 130 mg/dL or greater
- Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
- Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines
Exclusion Criteria
- Patient weighs less than 100 lbs
- Patient has an allergy to ezetimibe, simvastatin or atorvastatin
Data sourced from ClinicalTrials.gov (NCT00535405). 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.