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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vytorin | Experimental |
| |
| Other Statin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/simvastatin | Drug | Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
within previous 8 weeks
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| Other Statin | Drug | Participants are prescribed a statin (any other than Vytorin) as per routine standard of care |
|
| 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 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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