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)
NCT ID: NCT01587235
Last Updated: 2022-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-03-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vytorin
Ezetimibe/simvastatin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Other Statin
Other Statin
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
Interventions
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Ezetimibe/simvastatin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Other Statin
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Other Identifiers
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0653A-406
Identifier Type: -
Identifier Source: org_study_id
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