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The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
anacetrapib
Comparator: atorvastatin
Comparator: placebo to MK0859
Comparator: placebo to atorvastatin
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:

  • Patient's weight has been stable for at least 6 weeks
  • Patient is in good health based on medical history, physical exam, and laboratory tests
  • Patient has dyslipidemia

Exclusion Criteria :

  • Patient has a history of stroke, seizures, or major neurological disorders
  • Patient has a history of cancer
  • Patient is currently taking any lipid-lowering medications or substances except for statins
  • Patient consumes excessive amounts of alcohol or caffeine
  • Patient has multiple and/or severe allergies to food or drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Panel A

    Panel B

    Arm Description

    Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859

    Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin

    Outcomes

    Primary Outcome Measures

    Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone

    Secondary Outcome Measures

    Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo

    Full Information

    First Posted
    October 6, 2009
    Last Updated
    June 3, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00990808
    Brief Title
    The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
    Official Title
    A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    July 2011 (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 investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin 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 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Panel A
    Arm Type
    Experimental
    Arm Description
    Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859
    Arm Title
    Panel B
    Arm Type
    Experimental
    Arm Description
    Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    anacetrapib
    Intervention Description
    [Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin
    Intervention Description
    Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo to MK0859
    Intervention Description
    Placebo to MK0859 once daily for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo to atorvastatin
    Intervention Description
    Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
    Primary Outcome Measure Information:
    Title
    Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo
    Time Frame
    12 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: Patient's weight has been stable for at least 6 weeks Patient is in good health based on medical history, physical exam, and laboratory tests Patient has dyslipidemia Exclusion Criteria : Patient has a history of stroke, seizures, or major neurological disorders Patient has a history of cancer Patient is currently taking any lipid-lowering medications or substances except for statins Patient consumes excessive amounts of alcohol or caffeine Patient has multiple and/or severe allergies to food or drugs
    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
    25961461
    Citation
    Millar JS, Reyes-Soffer G, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Pollan L, Tohyama J, Johnson-Levonas AO, Wagner JA, Holleran S, Obunike J, Liu Y, Ramakrishnan R, Lassman ME, Gutstein DE, Ginsberg HN, Rader DJ. Anacetrapib lowers LDL by increasing ApoB clearance in mildly hypercholesterolemic subjects. J Clin Invest. 2015 Jun;125(6):2510-22. doi: 10.1172/JCI80025. Epub 2015 May 11. Erratum In: J Clin Invest. 2016 Apr 1;126(4):1603-4.
    Results Reference
    background
    PubMed Identifier
    28729361
    Citation
    Thomas T, Zhou H, Karmally W, Ramakrishnan R, Holleran S, Liu Y, Jumes P, Wagner JA, Hubbard B, Previs SF, Roddy T, Johnson-Levonas AO, Gutstein DE, Marcovina SM, Rader DJ, Ginsberg HN, Millar JS, Reyes-Soffer G. CETP (Cholesteryl Ester Transfer Protein) Inhibition With Anacetrapib Decreases Production of Lipoprotein(a) in Mildly Hypercholesterolemic Subjects. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1770-1775. doi: 10.1161/ATVBAHA.117.309549. Epub 2017 Jul 20.
    Results Reference
    derived

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    The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

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