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) (VYCTORY)
Status and phase
Withdrawn
Phase 4
Conditions
Dyslipidemia
Treatments
Drug: Other Statin
Drug: Ezetimibe/simvastatin
Details and patient eligibility
About
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.
Sex
All
Ages
18 to 79 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
0 participants in 2 patient groups
Vytorin
Experimental group
Treatment:
Drug: Ezetimibe/simvastatin
Other Statin
Active Comparator group
Treatment:
Drug: Other Statin
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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