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)

Study Overview
=================
Brief 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.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Atorvastatin 10 mg
* Drug: Ezetimibe 10 mg/simvastatin 20 mg
* Drug: Atorvastatin 20 mg
* Drug: Ezetimibe 10 mg/simvastatin 40 mg
* Drug: Atorvastatin 40 mg


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. | Drug: Atorvastatin 10 mg<br>* Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks<br>|
| Experimental: 2<br>Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. | Drug: Ezetimibe 10 mg/simvastatin 20 mg<br>* Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks<br>|
| Experimental: 3<br>Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. | Drug: Atorvastatin 20 mg<br>* Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks<br>|
| Experimental: 4<br>Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. | Drug: Ezetimibe 10 mg/simvastatin 40 mg<br>* Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks<br>|
| Experimental: 5<br>Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. | Drug: Atorvastatin 40 mg<br>* Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 |  | 12 weeks | 
| 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 | Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. | 12 Weeks | 
| Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 |  | 12 Weeks | 
| Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 | Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring. | 12 Weeks | 
| Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Cholesterol