VYCTORY: 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 Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Vytorin
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Drug: Ezetimibe/simvastatin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Other Names:
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Active Comparator: Other Statin
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Drug: Other Statin
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL
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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:
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LDL-C level ≥ 190 mg/dL
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Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin
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Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)
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Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
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Currently participating in or has previously participated in a study within 30 days
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Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months
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Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes
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Unstable angina pectoris
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Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months
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Unstable or severe peripheral artery disease within previous 3 months
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Uncontrolled hypertension (treated or untreated)
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Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)
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Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
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Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months
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Received treatment with systemic corticosteroids, any cyclical hormones
within previous 8 weeks
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0653A-406