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A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

Primary Purpose

Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia

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 focused on measuring Mixed Hyperlipidemia

Eligibility Criteria

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

Inclusion Criteria: Men and women 18-79 years of age with high cholesterol and high triglycerides. Exclusion Criteria: Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Plasma LDL-C.

    Secondary Outcome Measures

    Plasma HDL-C, non-HDL-C, and TG. Tolerability

    Full Information

    First Posted
    October 7, 2004
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00093899
    Brief Title
    A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)
    Official Title
    A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    September 2005 (Actual)
    Study Completion Date
    September 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
    The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia
    Keywords
    Mixed Hyperlipidemia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ezetimibe (+) simvastatin
    Other Intervention Name(s)
    MK0653A
    Intervention Description
    Duration of Treatment: 6 months
    Primary Outcome Measure Information:
    Title
    Plasma LDL-C.
    Secondary Outcome Measure Information:
    Title
    Plasma HDL-C, non-HDL-C, and TG. Tolerability

    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: Men and women 18-79 years of age with high cholesterol and high triglycerides. Exclusion Criteria: Individuals who do not meet specific cholesterol or triglyceride levels 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
    17239698
    Citation
    Farnier M, Roth E, Gil-Extremera B, Mendez GF, Macdonell G, Hamlin C, Perevozskaya I, Davies MJ, Kush D, Mitchel YB; Ezetimibe/Simvastatin + Fenofibrate Study Group. Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. Am Heart J. 2007 Feb;153(2):335.e1-8. doi: 10.1016/j.ahj.2006.10.031.
    Results Reference
    background
    PubMed Identifier
    18669979
    Citation
    Farnier M, Perevozskaya I, Taggart WV, Kush D, Mitchel YB. VAP II analysis of lipoprotein subclasses in mixed hyperlipidemic patients on treatment with ezetimibe/simvastatin and fenofibrate. J Lipid Res. 2008 Dec;49(12):2641-7. doi: 10.1194/jlr.P800034-JLR200. Epub 2008 Jul 31.
    Results Reference
    background
    PubMed Identifier
    18370800
    Citation
    Gil-Extremera B, Mendez G, Zakson M, Meehan A, Shah A, Lin J, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin co- administered with fenofibrate in mixed hyperlipidemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Dec;5(4):305-14. doi: 10.1089/met.2007.0011.
    Results Reference
    background
    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

    A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

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