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Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ezetimibe (+) simvastatin
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form.

Exclusion Criteria:

  • Any Another Kind Of Contraindication For Use Of Statins
  • Hypersensitivity To Any Of The Active Ingredients
  • Increased Serum Hepatic Enzymes (Over 3 Times Only)
  • Patients With Severe Hepatic Insufficiency
  • Women who are Pregnant or Potentially Pregnant

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals.

    Secondary Outcome Measures

    To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals.

    Full Information

    First Posted
    March 31, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00651560
    Brief Title
    Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)
    Official Title
    Vytorin As Strategy To Reduce Dislipidemia In Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2005 (Actual)
    Primary Completion Date
    December 23, 2005 (Actual)
    Study Completion Date
    December 23, 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    167 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe (+) simvastatin
    Other Intervention Name(s)
    Vytorin®, MK0653A
    Intervention Description
    ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.
    Primary Outcome Measure Information:
    Title
    Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals.
    Time Frame
    After 4 weeks treatment
    Secondary Outcome Measure Information:
    Title
    To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals.
    Time Frame
    After 4 weeks treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form. Exclusion Criteria: Any Another Kind Of Contraindication For Use Of Statins Hypersensitivity To Any Of The Active Ingredients Increased Serum Hepatic Enzymes (Over 3 Times Only) Patients With Severe Hepatic Insufficiency Women who are Pregnant or Potentially Pregnant
    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 Links
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

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    Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

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