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Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

Primary Purpose

Hypercholesterolemia, Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653, ezetimibe
Comparator: fenofibrate monotherapy
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring mixed hyperlipidemia, high cholesterol, high triglycerides

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: High cholesterol and high triglycerides Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Plasma LDL-C vs. fenofibrate for 12 weeks.

    Secondary Outcome Measures

    All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.

    Full Information

    First Posted
    September 23, 2004
    Last Updated
    February 3, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092560
    Brief Title
    Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
    Official Title
    Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 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 evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
    Detailed Description
    The duration of treatment is 18 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Hypertriglyceridemia
    Keywords
    mixed hyperlipidemia, high cholesterol, high triglycerides

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Enrollment
    587 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0653, ezetimibe
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: fenofibrate monotherapy
    Primary Outcome Measure Information:
    Title
    Plasma LDL-C vs. fenofibrate for 12 weeks.
    Secondary Outcome Measure Information:
    Title
    All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: High cholesterol and high triglycerides Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study
    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
    15781429
    Citation
    Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. doi: 10.1093/eurheartj/ehi231. Epub 2005 Mar 21.
    Results Reference
    background
    PubMed Identifier
    22087637
    Citation
    Farnier M, Dong Q, Shah A, Johnson-Levonas AO, Brudi P. Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin. Lipids Health Dis. 2011 Nov 16;10:212. doi: 10.1186/1476-511X-10-212.
    Results Reference
    derived
    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

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    Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

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