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Eze/Simva Switch Study in Diabetics (0653A-807)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
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 Diabetes Mellitus, Type 2

Eligibility Criteria

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

Inclusion Criteria:

  • Currently being treated with Atorvastatin 10 mg for at least 6 weeks
  • Have Type 2 Diabetes
  • Weight must be stable for more than 6 weeks before entering the study

Exclusion Criteria:

  • Consume more than 14 alcoholic drinks per week.
  • Pregnant or lactating
  • Have taken another investigation drug within 3 months of starting this study
  • History of congestive heart failure, heart attack, coronary artery bypass surgery
  • Uncontrolled high blood pressure
  • HIV positive
  • History of cancer in the last 5 years

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment

    Secondary Outcome Measures

    Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment

    Full Information

    First Posted
    October 5, 2007
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00541697
    Brief Title
    Eze/Simva Switch Study in Diabetics (0653A-807)
    Official Title
    A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 19, 2005 (Actual)
    Primary Completion Date
    September 28, 2005 (Actual)
    Study Completion Date
    October 14, 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
    A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    648 (Actual)

    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
    Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment
    Time Frame
    6 Weeks
    Secondary Outcome Measure Information:
    Title
    Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment
    Time Frame
    6 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently being treated with Atorvastatin 10 mg for at least 6 weeks Have Type 2 Diabetes Weight must be stable for more than 6 weeks before entering the study Exclusion Criteria: Consume more than 14 alcoholic drinks per week. Pregnant or lactating Have taken another investigation drug within 3 months of starting this study History of congestive heart failure, heart attack, coronary artery bypass surgery Uncontrolled high blood pressure HIV positive History of cancer in the last 5 years
    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

    Citations:
    PubMed Identifier
    17451425
    Citation
    Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Eze/Simva Switch Study in Diabetics (0653A-807)

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