Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
NCT ID: NCT01763827
Last Updated: 2022-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
615 participants
INTERVENTIONAL
2013-01-21
2013-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once daily
Placebo QM
Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once daily
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once daily
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once daily
Interventions
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Evolocumab
Administered by subcutaneous injection
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Placebo to Ezetimibe
Administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Carmichael, California, United States
Research Site
Encinitas, California, United States
Research Site
San Diego, California, United States
Research Site
Tustin, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Ponte Vedra, Florida, United States
Research Site
Sanford, Florida, United States
Research Site
Boise, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Louisville, Kentucky, United States
Research Site
Bethesda, Maryland, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Edina, Minnesota, United States
Research Site
Olive Branch, Mississippi, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Endwell, New York, United States
Research Site
New Windsor, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Fargo, North Dakota, United States
Research Site
Akron, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Anderson, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Jackson, Tennessee, United States
Research Site
Boerne, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Norfolk, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Renton, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Darlinghurst, New South Wales, Australia
Research Site
Maroubra, New South Wales, Australia
Research Site
Carina Heights, Queensland, Australia
Research Site
Sherwood, Queensland, Australia
Research Site
Anthée, , Belgium
Research Site
Brussels, , Belgium
Research Site
Gozée, , Belgium
Research Site
Gribomont, , Belgium
Research Site
Halen, , Belgium
Research Site
Ham, , Belgium
Research Site
Linkebeek, , Belgium
Research Site
Retie, , Belgium
Research Site
Tessenderlo, , Belgium
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Granby, Quebec, Canada
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Gières, , France
Research Site
Grenoble, , France
Research Site
Alberton, Gauteng, South Africa
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Parow, Western Cape, South Africa
Research Site
Somerset West, Western Cape, South Africa
Research Site
Worcester, Western Cape, South Africa
Research Site
Bloemfontein, , South Africa
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H; MENDEL-2 Investigators. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2531-2540. doi: 10.1016/j.jacc.2014.03.018. Epub 2014 Mar 29.
Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.
Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.
Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.
Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.
Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.
Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.
May HT, Muhlestein JB, Ma Y, Lopez JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110114
Identifier Type: -
Identifier Source: org_study_id
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