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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)

Primary Purpose

Dyslipidemia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ezetimibe/simvastatin
Other Statin
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vytorin

    Other Statin

    Arm Description

    Outcomes

    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)

    Secondary Outcome Measures

    Change in LDL-C level From Baseline
    Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL
    Change in Serum LDL From Baseline
    Change in Total Cholesterol From Baseline
    Change in High-density lipoprotein (HDL) From Baseline
    Change in Serum Triglycerides (TG) From Baseline
    Change in Serum Non-HDL From Baseline
    Change in LDL-C/HDL-C Ratio From Baseline
    Change in Apolipoprotein B (ApoB) From Baseline
    Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL))

    Full Information

    First Posted
    April 26, 2012
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01587235
    Brief Title
    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)
    Acronym
    VYCTORY
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    May 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vytorin
    Arm Type
    Experimental
    Arm Title
    Other Statin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe/simvastatin
    Other Intervention Name(s)
    Vytorin
    Intervention Description
    Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Other Statin
    Intervention Description
    Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
    Primary Outcome Measure Information:
    Title
    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)
    Time Frame
    Week 6
    Secondary Outcome Measure Information:
    Title
    Change in LDL-C level From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Number of High-risk Participants who Achieve an LDL-C < 70 mg/dL
    Time Frame
    Week 6
    Title
    Change in Serum LDL From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Change in Total Cholesterol From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Change in High-density lipoprotein (HDL) From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Change in Serum Triglycerides (TG) From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Change in Serum Non-HDL From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Change in LDL-C/HDL-C Ratio From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Change in Apolipoprotein B (ApoB) From Baseline
    Time Frame
    Baseline and Week 6
    Title
    Number of Participants who Achieve non-HDL-C goal (High-risk <100 mg/dL; Moderate-high and High risk <160 mg/dL))
    Time Frame
    Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    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)

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