A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.

Official Title
-----------------
A Multicenter, Open-label, 6 Week Study to Evaluate the Efficacy and Safety of Algorithm Based Intensive Treatment With Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Patients.

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Ezetimibe/simvastatin
* Drug: Other Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment Exclusion Criteria: LDL-C level ≥ 190 mg/dL Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc) Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study Currently participating in or has previously participated in a study within 30 days Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes Unstable angina pectoris Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months Unstable or severe peripheral artery disease within previous 3 months Uncontrolled hypertension (treated or untreated) Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months) Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months Received treatment with systemic corticosteroids, any cyclical hormones within previous 8 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vytorin<br> | Drug: Ezetimibe/simvastatin<br>* Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.<br>* Other names: Vytorin;|
| Active Comparator: Other Statin<br> | Drug: Other Statin<br>* Participants are prescribed a statin (any other than Vytorin) as per routine standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Achieve Low-density Lipoprotein Cholesterol (LDL-C) goal (High-risk <100 mg/dL; Moderate-high and High risk <130 mg/dL) |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C level From Baseline |  | Baseline and Week 6 | 
| Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL |  | Week 6 | 
| Change in Serum LDL From Baseline |  | Baseline and Week 6 | 
| Change in Total Cholesterol From Baseline |  | Baseline and Week 6 | 
| Change in High-density lipoprotein (HDL) From Baseline |  | Baseline and Week 6 | 
| Change in Serum Triglycerides (TG) From Baseline |  | Baseline and Week 6 | 
| Change in Serum Non-HDL From Baseline |  | Baseline and Week 6 | 
| Change in LDL-C/HDL-C Ratio From Baseline |  | Baseline and Week 6 | 
| Change in Apolipoprotein B (ApoB) From Baseline |  | Baseline and Week 6 | 
| Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL)) |  | Week 6 |