Phase 3
N=1,053
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00418834 ↗Enrolled (actual)
1,053
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Percent Change From Baseline in LDL-C at Week 6 — -26.7; -12.8 Percent Change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ezetimibe and atorvastatin (Drug); atorvastatin (Drug); Placebo (unspecified) (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-C at Week 6 |
-26.7; -12.8 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-22.5; -17.9 | <0.001 sig |
| SECONDARY Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 |
244; 92; 271; 423 | <0.001 sig |
| SECONDARY Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 |
225; 164; 291; 345 | <0.001 sig |
| SECONDARY Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 |
274; 127; 241; 388 | <0.001 sig |
| SECONDARY Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 |
255; 200; 261; 309 | <0.001 sig |
Summary
A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.
Eligibility Criteria
Inclusion Criteria
- Patient is age 65 or older
- Patient is willing to maintain cholesterol lowering diet
- Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category
Exclusion Criteria
- A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study
- Patient is unlikely to be compliant in taking study medication
- Patient with chronic or unstable medical condition
- Patient is taking unstable doses of medication
- Patient drinks more than 2 alcoholic drinks per day
- Patient has elevations in certain laboratory values (CK, AST, ALT)
Data sourced from ClinicalTrials.gov (NCT00418834). 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.