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Endpoint Validation Study (0524A-015)

Primary Purpose

Flushing

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0524A, /Duration of Treatment : 8 Weeks
Comparator : placebo (unspecified) /Duration of Treatment : 8 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:

  • Patients must be male or female between 18 to 70 years
  • Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control

Exclusion Criteria:

  • You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
  • You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
  • You are sensitive to niacin
  • You have a history gout
  • You drink more than 2 glasses of alcohol per day and you are not willing to stop
  • You don't have access to a telephone

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).

    Secondary Outcome Measures

    To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.

    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
    NCT00533676
    Brief Title
    Endpoint Validation Study (0524A-015)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 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
    To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    165 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0524A, /Duration of Treatment : 8 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks
    Primary Outcome Measure Information:
    Title
    To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
    Time Frame
    8 weeks

    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: Patients must be male or female between 18 to 70 years Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control Exclusion Criteria: You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day You are sensitive to niacin You have a history gout You drink more than 2 glasses of alcohol per day and you are not willing to stop You don't have access to a telephone
    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
    17559750
    Citation
    Norquist JM, Watson DJ, Yu Q, Paolini JF, McQuarrie K, Santanello NC. Validation of a questionnaire to assess niacin-induced cutaneous flushing. Curr Med Res Opin. 2007 Jul;23(7):1549-60. doi: 10.1185/030079907x199637.
    Results Reference
    background
    PubMed Identifier
    18410350
    Citation
    Paolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E, Watson DJ, Norquist JM, Sisk CM, Bays HE. Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Int J Clin Pract. 2008 Jun;62(6):896-904. doi: 10.1111/j.1742-1241.2008.01739.x. Epub 2008 Apr 10.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Snyopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Endpoint Validation Study (0524A-015)

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