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Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

Primary Purpose

Flushing

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0524A, /Duration of Treatment : 4 Weeks
Comparator : niacin /Duration of Treatment : 1 Weeks
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flushing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is male or female between 18 and 70 years of age
  • Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion Criteria:

  • Patient has a history of hypersensitivity to niacin or niacin-containing products
  • Patient is currently experiencing menopausal hot flashes
  • Patient consumes more than 2 alcoholic beverages per day
  • Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
  • Patient engages in vigorous exercise or an aggressive diet regimen

Sites / Locations

    Outcomes

    Primary Outcome Measures

    MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.

    Secondary Outcome Measures

    MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).

    Full Information

    First Posted
    September 19, 2007
    Last Updated
    February 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00533611
    Brief Title
    Effect of MK0524A on Flushing Caused by Niacin (0524A-056)
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (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
    The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0524A, /Duration of Treatment : 4 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : niacin /Duration of Treatment : 1 Weeks
    Primary Outcome Measure Information:
    Title
    MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.
    Time Frame
    Over 1 week
    Secondary Outcome Measure Information:
    Title
    MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).
    Time Frame
    Daily

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is male or female between 18 and 70 years of age Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: Patient has a history of hypersensitivity to niacin or niacin-containing products Patient is currently experiencing menopausal hot flashes Patient consumes more than 2 alcoholic beverages per day Patient has poorly controlled Type 1 or Type 2 diabetes mellitus Patient engages in vigorous exercise or an aggressive diet regimen
    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
    19602880
    Citation
    Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.
    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

    Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

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