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Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

Primary Purpose

Cardiovascular Diseases, Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Comparator: atorvastatin / Duration of Treatment: 6 Weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Greater than 18 years of age
  • Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
  • Existing coronary heart disease and cholesterol > 4.0 mmol/l

Exclusion Criteria:

  • Uncontrolled diabetes
  • Elevated liver function tests
  • Elevated creatine kinase (ck)
  • Triglycerides (tg) > 4.5 mmol/l
  • Drug or alcohol dependency within 6 months prior to visit 1
  • Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
  • Woman of childbearing potential not using an acceptable method of birth control
  • Women who are pregnant or breast feeding

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage reduction in ldl-c at end-point after 6 weeks.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00395603
    Brief Title
    Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
    Official Title
    Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    This study was terminated early due to poor recruitment.
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    550 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin / Duration of Treatment: 6 Weeks
    Primary Outcome Measure Information:
    Title
    Percentage reduction in ldl-c at end-point after 6 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than 18 years of age Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg Existing coronary heart disease and cholesterol > 4.0 mmol/l Exclusion Criteria: Uncontrolled diabetes Elevated liver function tests Elevated creatine kinase (ck) Triglycerides (tg) > 4.5 mmol/l Drug or alcohol dependency within 6 months prior to visit 1 Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study Woman of childbearing potential not using an acceptable method of birth control Women who are pregnant or breast feeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.merck.com/clinical-trials/policies-perspectives.html
    Description
    Click here to access a synopsis of the study results.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis Link
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

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