Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

Last updated: November 4, 2022
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Dyslipidemia

Elevated Triglycerides (Hypertriglyceridemia)

Treatment

N/A

Clinical Study ID

NCT01763827
20110114
  • Ages 18-80
  • All Genders

Study Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)Framingham risk score of 10% or less
  • Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion

Exclusion Criteria:

  • History of coronary heart disease
  • New York Heart Association (NYHA) III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
  • Uncontrolled hypothyroidism or hyperthyroidism

Study Design

Total Participants: 615
Study Start date:
January 21, 2013
Estimated Completion Date:
October 29, 2013

Connect with a study center

  • Research Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Research Site

    Maroubra, New South Wales 2035
    Australia

    Site Not Available

  • Research Site

    Carina Heights, Queensland 4152
    Australia

    Site Not Available

  • Research Site

    Sherwood, Queensland 4075
    Australia

    Site Not Available

  • Research Site

    Anthée, 5520
    Belgium

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  • Research Site

    Anthée, 5520
    Belgium

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  • Research Site

    Bruxelles, 1080
    Belgium

    Site Not Available

  • Research Site

    Gozee, 6534
    Belgium

    Site Not Available

  • Research Site

    Gribomont, 6887
    Belgium

    Site Not Available

  • Research Site

    Halen, 3545
    Belgium

    Site Not Available

  • Research Site

    Ham, 3945
    Belgium

    Site Not Available

  • Research Site

    Linkebeek, 1630
    Belgium

    Site Not Available

  • Research Site

    Retie, 2470
    Belgium

    Site Not Available

  • Research Site

    Tessenderlo, 3980
    Belgium

    Site Not Available

  • Research Site

    Bay Roberts, Newfoundland and Labrador A0A 1G0
    Canada

    Site Not Available

  • Research Site

    Mount Pearl, Newfoundland and Labrador A1N 1W7
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M9W 4L6
    Canada

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  • Research Site

    Granby, Quebec J2G 8Z9
    Canada

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  • Research Site

    Aalborg, 9000
    Denmark

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  • Research Site

    Ballerup, 2750
    Denmark

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  • Research Site

    Vejle, 7100
    Denmark

    Site Not Available

  • Research Site

    Gières, 38610
    France

    Site Not Available

  • Research Site

    Gières, 38610
    France

    Site Not Available

  • Research Site

    Grenoble Cedex 9, 38043
    France

    Site Not Available

  • Research Site

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Research Site

    Alberton, Gauteng 1449
    South Africa

    Site Not Available

  • Research Site

    Johannesburg, Gauteng 2196
    South Africa

    Site Not Available

  • Research Site

    Parow, Western Cape 7505
    South Africa

    Site Not Available

  • Research Site

    Somerset West, Western Cape 7130
    South Africa

    Site Not Available

  • Research Site

    Worcester, Western Cape 6850
    South Africa

    Site Not Available

  • Research Site

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • Research Site

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 100
    Taiwan

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  • Research Site

    Istanbul, 34662
    Turkey

    Site Not Available

  • Research Site

    Birmingham, Alabama 35216
    United States

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  • Research Site

    Chandler, Arizona 85224
    United States

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  • Research Site

    Little Rock, Arkansas 72205
    United States

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  • Research Site

    Carmichael, California 95608
    United States

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  • Research Site

    Encinitas, California 92024
    United States

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  • Research Site

    San Diego, California 92111
    United States

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  • Research Site

    Tustin, California 92780
    United States

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  • Research Site

    Jacksonville, Florida 32216
    United States

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  • Research Site

    Miami, Florida 33144
    United States

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  • Research Site

    Ponte Vedra, Florida 32081
    United States

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  • Research Site

    Sanford, Florida 32771
    United States

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  • Research Site

    Boise, Idaho 83704
    United States

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  • Research Site

    Chicago, Illinois 60654
    United States

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  • Research Site

    Indianapolis, Indiana 46260
    United States

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  • Research Site

    Overland Park, Kansas 66202
    United States

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  • Research Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Research Site

    Bethesda, Maryland 20817
    United States

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  • Research Site

    Brockton, Massachusetts 02301
    United States

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  • Research Site

    Edina, Minnesota 55435
    United States

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  • Research Site

    Olive Branch, Mississippi 38654
    United States

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  • Research Site

    Las Vegas, Nevada 89148
    United States

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  • Research Site

    Endwell, New York 13760
    United States

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  • Research Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • Research Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Research Site

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Research Site

    Akron, Ohio 44311
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45246
    United States

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  • Research Site

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Research Site

    Norman, Oklahoma 73069
    United States

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  • Research Site

    Oklahoma City, Oklahoma 73103
    United States

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  • Research Site

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Research Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Research Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Research Site

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Research Site

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Research Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Research Site

    Boerne, Texas 78006
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75230
    United States

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  • Research Site

    San Antonio, Texas 78205
    United States

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  • Research Site

    Salt Lake City, Utah 84124
    United States

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  • Research Site

    Norfolk, Virginia 23502
    United States

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  • Research Site

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Research Site

    Renton, Washington 98057
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98104
    United States

    Site Not Available

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