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Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

Primary Purpose

Hypercholesterolemia, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
niacin (+) laropiprant
niacin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Primary Hypercholesterolemia or Mixed Hyperlipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL

Exclusion Criteria:

  • Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin
  • Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL.
  • Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Global Flushing Severity Score (GFSS) over 16 weeks

    Secondary Outcome Measures

    Safety/tolerability

    Full Information

    First Posted
    September 20, 2006
    Last Updated
    February 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00378833
    Brief Title
    Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)
    Official Title
    A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2006 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    March 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
    This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1300 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    niacin (+) laropiprant
    Other Intervention Name(s)
    MK0524A
    Intervention Description
    Duration of Treatment: 18 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    niacin
    Intervention Description
    Duration of Treatment: 18 Weeks
    Primary Outcome Measure Information:
    Title
    Global Flushing Severity Score (GFSS) over 16 weeks
    Secondary Outcome Measure Information:
    Title
    Safety/tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL Exclusion Criteria: Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL. Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.
    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
    19576324
    Citation
    Maccubbin D, Koren MJ, Davidson M, Gavish D, Pasternak RC, Macdonell G, Mallick M, Sisk CM, Paolini JF, Mitchel Y. Flushing profile of extended-release niacin/laropiprant versus gradually titrated niacin extended-release in patients with dyslipidemia with and without ischemic cardiovascular disease. Am J Cardiol. 2009 Jul 1;104(1):74-81. doi: 10.1016/j.amjcard.2009.02.047.
    Results Reference
    result
    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

    Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

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