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A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK1903
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is not on a statin or other lipid-modifying therapy
  • Low or moderate risk participant
  • Male participants, and female participants not of reproductive potential

Exclusion Criteria:

  • Female participant of reproductive potential
  • Participant is pregnant, breastfeeding, or expecting to conceive during the study
  • Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
  • Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
  • Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
  • Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
  • Participant is currently experiencing menopausal hot flashes
  • Participant currently engages in vigorous exercise or an aggressive diet regimen
  • Participant is at high risk for heart conditions
  • Participant has Type 1 or Type 2 diabetes mellitus
  • Participant has poorly controlled cardiac arrhythmias
  • Participant has a history of stroke or other hemorrhage
  • Participant has poorly controlled high blood pressure
  • Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
  • Participant has a disease of the kidney or liver
  • Participant has an ulcer within 3 months of screening
  • Participant is Human Immunodeficiency Virus (HIV) positive
  • Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
  • Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
  • Participant has taken an anti-obesity medication within 3 months of screening
  • Participant is taking coumarins
  • Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
  • Participant is taking more than 100 mg aspirin per day
  • Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    MK1903

    Placebo to MK1903

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
    Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)

    Secondary Outcome Measures

    Percent Change From Baseline in Triglycerides (mg/dL)

    Full Information

    First Posted
    February 18, 2009
    Last Updated
    November 19, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00847197
    Brief Title
    A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2009 (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 the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    191 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK1903
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to MK1903
    Intervention Type
    Drug
    Intervention Name(s)
    MK1903
    Intervention Description
    Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
    Time Frame
    Baseline and Week 4
    Title
    Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
    Time Frame
    Baseline and Week 4
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in Triglycerides (mg/dL)
    Time Frame
    Baseline and 4 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: Participant is not on a statin or other lipid-modifying therapy Low or moderate risk participant Male participants, and female participants not of reproductive potential Exclusion Criteria: Female participant of reproductive potential Participant is pregnant, breastfeeding, or expecting to conceive during the study Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer) Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week Participant is currently experiencing menopausal hot flashes Participant currently engages in vigorous exercise or an aggressive diet regimen Participant is at high risk for heart conditions Participant has Type 1 or Type 2 diabetes mellitus Participant has poorly controlled cardiac arrhythmias Participant has a history of stroke or other hemorrhage Participant has poorly controlled high blood pressure Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids Participant has a disease of the kidney or liver Participant has an ulcer within 3 months of screening Participant is Human Immunodeficiency Virus (HIV) positive Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening Participant has taken an anti-obesity medication within 3 months of screening Participant is taking coumarins Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed) Participant is taking more than 100 mg aspirin per day Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
    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

    A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)

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