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)

Sponsor
Organon and Co (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01587235
Collaborator
(none)
0
2
14

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Mar 1, 2013
Anticipated Primary Completion Date :
May 1, 2014
Anticipated Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vytorin

Drug: Ezetimibe/simvastatin
Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
Other Names:
  • Vytorin
  • Active Comparator: Other Statin

    Drug: Other Statin
    Participants are prescribed a statin (any other than Vytorin) as per routine standard of care

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. Change in LDL-C level From Baseline [Baseline and Week 6]

    2. Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL [Week 6]

    3. Change in Serum LDL From Baseline [Baseline and Week 6]

    4. Change in Total Cholesterol From Baseline [Baseline and Week 6]

    5. Change in High-density lipoprotein (HDL) From Baseline [Baseline and Week 6]

    6. Change in Serum Triglycerides (TG) From Baseline [Baseline and Week 6]

    7. Change in Serum Non-HDL From Baseline [Baseline and Week 6]

    8. Change in LDL-C/HDL-C Ratio From Baseline [Baseline and Week 6]

    9. Change in Apolipoprotein B (ApoB) From Baseline [Baseline and Week 6]

    10. 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

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01587235
    Other Study ID Numbers:
    • 0653A-406
    First Posted:
    Apr 30, 2012
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    No Results Posted as of Feb 18, 2022