search
Back to results

Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe / Duration of Treatment: 28 weeks
Comparator: atorvastatin / Duration of Treatment: 28 weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria: Elevated cholesterol levels Exclusion Criteria: Liver disease Unstable medical conditions

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.

    Secondary Outcome Measures

    Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
    Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

    Full Information

    First Posted
    September 23, 2004
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00092716
    Brief Title
    Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0653, ezetimibe / Duration of Treatment: 28 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin / Duration of Treatment: 28 weeks
    Primary Outcome Measure Information:
    Title
    To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
    Secondary Outcome Measure Information:
    Title
    Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
    Title
    Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

    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: Elevated cholesterol levels Exclusion Criteria: Liver disease Unstable medical conditions

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15194018
    Citation
    Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004 Jun 15;93(12):1487-94. doi: 10.1016/j.amjcard.2004.02.060.
    Results Reference
    background
    PubMed Identifier
    16369229
    Citation
    McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3.
    Results Reference
    background
    PubMed Identifier
    16004682
    Citation
    Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642.
    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

    Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

    We'll reach out to this number within 24 hrs