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
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.
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 18, 2022
February 1, 2022
1.2 years
April 26, 2012
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
Vytorin
EXPERIMENTALOther Statin
ACTIVE COMPARATORInterventions
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2012
First Posted
April 30, 2012
Study Start
March 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 18, 2022
Record last verified: 2022-02