search
Back to results

MK0524A Phase IIb Study (0524A-011)(COMPLETED)

Primary Purpose

Flushing

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: niacin / Duration of Treatment: 17 Weeks
MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
Comparator: placebo (unspecified) / Duration of Treatment: 17 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:

  • Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening
  • Must be willing to complete electronic diary

Exclusion Criteria:

  • Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
  • You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
  • You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To determine the effect of MK0524A on lipids and blood glucose

    Secondary Outcome Measures

    To establish the dose for limiting flushing symptoms induced by NIASPAN (R)

    Full Information

    First Posted
    September 26, 2007
    Last Updated
    August 24, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00536237
    Brief Title
    MK0524A Phase IIb Study (0524A-011)(COMPLETED)
    Official Title
    Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    February 2005 (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
    Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone. Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.

    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
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: niacin / Duration of Treatment: 17 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks
    Primary Outcome Measure Information:
    Title
    To determine the effect of MK0524A on lipids and blood glucose
    Time Frame
    17 Weeks
    Secondary Outcome Measure Information:
    Title
    To establish the dose for limiting flushing symptoms induced by NIASPAN (R)
    Time Frame
    17 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: Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening Must be willing to complete electronic diary Exclusion Criteria: Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT) You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
    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
    18308010
    Citation
    Paolini JF, Mitchel YB, Reyes R, Kher U, Lai E, Watson DJ, Norquist JM, Meehan AG, Bays HE, Davidson M, Ballantyne CM. Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am J Cardiol. 2008 Mar 1;101(5):625-30. doi: 10.1016/j.amjcard.2007.10.023. Epub 2007 Dec 21.
    Results Reference
    background

    Learn more about this trial

    MK0524A Phase IIb Study (0524A-011)(COMPLETED)

    We'll reach out to this number within 24 hrs