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To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: ezetimibe/simvastatin + niacin (ER)
Comparator: Placebo to ezetimibe/simvastatin
Comparator: niacin (ER) tablet
Comparator: ezetimibe (+) simvastatin
Comparator: Placebo to Niacin (ER)
Comparator: ezetimibe/simvastatin and niacin (ER)
Comparator: ezetimibe and simvastatin
Comparator: Placebo to niacin (ER)
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL Patient willing to be on a low-cholesterol diet Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Part 1 - Arm 1

    Part 1 -Arm 2

    Part 1 - Arm 3

    Part 2 - Arm 1

    Part 2 - Arm 2

    Arm Description

    ezetimibe/simvastatin combination tablet + niacin (ER)

    ezetimibe/simvastatin

    Niacin (ER)

    ezetimibe/simvastatin combination tablet + niacin (ER)

    ezetimibe/simvastatin combination tablet + niacin (Pbo)

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
    Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline

    Secondary Outcome Measures

    Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
    Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline
    Percent Change From Baseline in Triglycerides (TG)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline
    Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline
    Percent Change From Baseline in Triglycerides (TG)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline
    Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline
    Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline
    Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline

    Full Information

    First Posted
    January 3, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00271817
    Brief Title
    To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
    Official Title
    Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    February 2008 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1220 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1 - Arm 1
    Arm Type
    Active Comparator
    Arm Description
    ezetimibe/simvastatin combination tablet + niacin (ER)
    Arm Title
    Part 1 -Arm 2
    Arm Type
    Active Comparator
    Arm Description
    ezetimibe/simvastatin
    Arm Title
    Part 1 - Arm 3
    Arm Type
    Active Comparator
    Arm Description
    Niacin (ER)
    Arm Title
    Part 2 - Arm 1
    Arm Type
    Active Comparator
    Arm Description
    ezetimibe/simvastatin combination tablet + niacin (ER)
    Arm Title
    Part 2 - Arm 2
    Arm Type
    Placebo Comparator
    Arm Description
    ezetimibe/simvastatin combination tablet + niacin (Pbo)
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ezetimibe/simvastatin + niacin (ER)
    Intervention Description
    ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo to ezetimibe/simvastatin
    Intervention Description
    ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: niacin (ER) tablet
    Intervention Description
    niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ezetimibe (+) simvastatin
    Intervention Description
    ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo to Niacin (ER)
    Intervention Description
    Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ezetimibe/simvastatin and niacin (ER)
    Intervention Description
    ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: ezetimibe and simvastatin
    Intervention Description
    ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo to niacin (ER)
    Intervention Description
    Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
    Time Frame
    Baseline and 24 Weeks
    Title
    Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline
    Time Frame
    Baseline and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
    Time Frame
    Baseline and 24 weeks
    Title
    Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline
    Time Frame
    Baseline and 24 weeks
    Title
    Percent Change From Baseline in Triglycerides (TG)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline
    Time Frame
    baseline and 24 Weeks
    Title
    Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline
    Time Frame
    Baseline and 64 weeks
    Title
    Percent Change From Baseline in Triglycerides (TG)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline
    Time Frame
    Baseline and 64 weeks
    Title
    Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline
    Time Frame
    Baseline and 64 weeks
    Title
    Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline
    Time Frame
    Baseline and 64 weeks
    Title
    Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
    Description
    Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
    Time Frame
    Baseline and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL Patient willing to be on a low-cholesterol diet Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    18420099
    Citation
    Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003.
    Results Reference
    background
    PubMed Identifier
    23926117
    Citation
    Le NA, Jin R, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. J Am Heart Assoc. 2013 Aug 7;2(4):e000037. doi: 10.1161/JAHA.113.000037.
    Results Reference
    derived
    PubMed Identifier
    22338103
    Citation
    Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. doi: 10.2337/dc11-1369. Epub 2012 Feb 14.
    Results Reference
    derived

    Learn more about this trial

    To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

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