Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: ezetimibe and atorvastatin
* Drug: atorvastatin
* Drug: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: ezetimibe and atorvastatin<br>* ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks<br>Drug: Placebo (unspecified)<br>* Placebo (unspecified) daily for 12 weeks<br>|
| Active Comparator: 2<br> | Drug: atorvastatin<br>* Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks<br>Drug: Placebo (unspecified)<br>* Placebo (unspecified) daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in LDL-C at Week 6 |  | Baseline and Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |  | Baseline and Week 12 | 
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 |  | Week 6 | 
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 |  | Week 12 | 
| 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 |  | Week 6 | 
| 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 |  | Week 12 |