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Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Niaspan
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Male Subjects

Exclusion Criteria :

  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm A

    Arm B

    Arm Description

    Arm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2

    Arm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2

    Outcomes

    Primary Outcome Measures

    Change from baseline in cholesterol efflux
    Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2010
    Last Updated
    October 9, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01071291
    Brief Title
    Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Niaspan™ on Reverse Cholesterol Transport in Healthy Male Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    August 2010 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of cholesterol.

    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 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Experimental
    Arm Description
    Arm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2
    Arm Title
    Arm B
    Arm Type
    Experimental
    Arm Description
    Arm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2
    Intervention Type
    Drug
    Intervention Name(s)
    Niaspan
    Other Intervention Name(s)
    NIASPAN™
    Intervention Description
    Niaspan™
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Change from baseline in cholesterol efflux
    Time Frame
    Baseline and 12 weeks
    Title
    Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)
    Time Frame
    Baseline and 6 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Male Subjects Exclusion Criteria : Subject has a history of stroke, chronic seizures, or major neurological disorder Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
    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

    Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)

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