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Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Primary Purpose

Primary Hypercholesterolemia, Mixed Dyslipidemia

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

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
  • Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria:

  • Patient whose LDL-C values are not within protocol specified range

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

    Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12

    Secondary Outcome Measures

    Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
    Percent Change From Baseline in Triglycerides at Week 12

    Full Information

    First Posted
    May 24, 2007
    Last Updated
    February 20, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00479388
    Brief Title
    Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
    Official Title
    A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    October 2008 (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 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1216 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: simvastatin
    Other Intervention Name(s)
    Zocor®
    Intervention Description
    simvastatin (20mg to 40mg) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    niacin (+) laropiprant
    Other Intervention Name(s)
    MK0524A
    Intervention Description
    One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin calcium
    Other Intervention Name(s)
    atorvastatin
    Intervention Description
    atorvastatin calcium (20mg to 40mg) for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
    Time Frame
    Baseline and 12 Weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
    Time Frame
    Baseline and 12 Weeks
    Title
    Percent Change From Baseline in Triglycerides at Week 12
    Time Frame
    Baseline and 12 Weeks

    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: Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria Exclusion Criteria: Patient whose LDL-C values are not within protocol specified range
    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
    20518948
    Citation
    Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2010 May;64(6):727-38. doi: 10.1111/j.1742-1241.2010.02370.x.
    Results Reference
    result
    PubMed Identifier
    22500948
    Citation
    Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.
    Results Reference
    derived
    PubMed Identifier
    21401833
    Citation
    Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.
    Results Reference
    derived

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    Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

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