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MK0354 Clinical Efficacy and Tolerability Study (0354-004)

Primary Purpose

Dyslipidemia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0354
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

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

Inclusion Criteria: Patient is between 18 and 75 years of age You have taken a statin or other lipid modifying therapy in the last 6-8 weeks You have lipid lab values outside of the range specified in the protocol Exclusion Criteria: Patient is a woman who is pregnant or nursing a child Patient is a woman who is taking hormonal birth-control You are a woman who is planning to donate eggs during the study You plan to give blood during the study or have given within the last 8 weeks You are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes You have a known intolerance to or you are allergic to niacin You have any of the following medical conditions: Poorly controlled or newly diagnosed diabetes (within the last 3 months) Thyroid disease (hypothyroidism or hyperthyroidism) A history of stroke, heart attack, coronary bypass surgery, angioplasty, unstable angina or similar heart and artery procedures in the past 3 months History of hemorrhagic stroke or other non-traumatic hemorrhage Peptic ulcer disease in the last 3 months An occurrence of gout within the last year and you are not currently taking allopurinol Cancer (except for successfully treated skin cancer) HIV positive You have a history of drug/alcohol abuse within the last year You consume more than 2 drinks of alcohol per day You do not have access to a telephone You take medications that are not allowed in this study. The study doctor or staff will discuss this with you. Patient has participated in a study with an investigational drug within the last 30 days

Sites / Locations

    Outcomes

    Primary Outcome Measures

    proprietary information - exploratory (non-confirmatory) trial

    Secondary Outcome Measures

    proprietary information - exploratory (non-confirmatory) trial

    Full Information

    First Posted
    June 14, 2006
    Last Updated
    May 15, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00337415
    Brief Title
    MK0354 Clinical Efficacy and Tolerability Study (0354-004)
    Official Title
    Proprietary Information - Exploratory (Non-Confirmatory) Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder of lipids in the blood) This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0354
    Primary Outcome Measure Information:
    Title
    proprietary information - exploratory (non-confirmatory) trial
    Secondary Outcome Measure Information:
    Title
    proprietary information - exploratory (non-confirmatory) trial

    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: Patient is between 18 and 75 years of age You have taken a statin or other lipid modifying therapy in the last 6-8 weeks You have lipid lab values outside of the range specified in the protocol Exclusion Criteria: Patient is a woman who is pregnant or nursing a child Patient is a woman who is taking hormonal birth-control You are a woman who is planning to donate eggs during the study You plan to give blood during the study or have given within the last 8 weeks You are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes You have a known intolerance to or you are allergic to niacin You have any of the following medical conditions: Poorly controlled or newly diagnosed diabetes (within the last 3 months) Thyroid disease (hypothyroidism or hyperthyroidism) A history of stroke, heart attack, coronary bypass surgery, angioplasty, unstable angina or similar heart and artery procedures in the past 3 months History of hemorrhagic stroke or other non-traumatic hemorrhage Peptic ulcer disease in the last 3 months An occurrence of gout within the last year and you are not currently taking allopurinol Cancer (except for successfully treated skin cancer) HIV positive You have a history of drug/alcohol abuse within the last year You consume more than 2 drinks of alcohol per day You do not have access to a telephone You take medications that are not allowed in this study. The study doctor or staff will discuss this with you. Patient has participated in a study with an investigational drug within the last 30 days
    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

    Learn more about this trial

    MK0354 Clinical Efficacy and Tolerability Study (0354-004)

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