Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
NCT ID: NCT01516879
Last Updated: 2022-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
905 participants
INTERVENTIONAL
2012-01-05
2013-10-14
Brief Summary
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Detailed Description
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1. no drug therapy required - diet alone
2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)
3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD
4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.
If the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Evolocumab
Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Evolocumab
Administered by subcutaneous injection once a month
Atorvastatin
Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
Ezetimibe
Background lipid lowering therapy: ezetimibe 10 mg orally once a day
Diet Only
Diet only, no lipid lowering background drug given
Placebo
Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Placebo
Administered by subcutaneous injection once a month
Atorvastatin
Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
Ezetimibe
Background lipid lowering therapy: ezetimibe 10 mg orally once a day
Diet Only
Diet only, no lipid lowering background drug given
Interventions
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Evolocumab
Administered by subcutaneous injection once a month
Placebo
Administered by subcutaneous injection once a month
Atorvastatin
Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
Ezetimibe
Background lipid lowering therapy: ezetimibe 10 mg orally once a day
Diet Only
Diet only, no lipid lowering background drug given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:
* \< 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent
* \< 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
* OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
* Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes
* Uncontrolled hypertension
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
Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Encinitas, California, United States
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Spring Valley, California, United States
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Westlake Village, California, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Ponte Vedra, Florida, United States
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Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Savannah, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Auburn, Maine, United States
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Bethesda, Maryland, United States
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Chevy Chase, Maryland, United States
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Columbia, Maryland, United States
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Brockton, Massachusetts, United States
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Saint Paul, Minnesota, United States
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Olive Branch, Mississippi, United States
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Las Vegas, Nevada, United States
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Endwell, New York, United States
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New Windsor, New York, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Norman, Oklahoma, United States
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Duncansville, Pennsylvania, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
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Houston, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Renton, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Maroubra, New South Wales, Australia
Research Site
Carina Heights, Queensland, Australia
Research Site
Milton, Queensland, Australia
Research Site
Fitzroy, Victoria, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Feldkirch, , Austria
Research Site
Innsbruck, , Austria
Research Site
Salzburg, , Austria
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Wels, , Austria
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Anthée, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Gozée, , Belgium
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Ham, , Belgium
Research Site
Ostend, , Belgium
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Victoria, British Columbia, Canada
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
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Cambridge, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Chomutov, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Pardubice, , Czechia
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Pilsen, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Slaný, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Baja, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Komárom, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Lyttelton, Gauteng, South Africa
Research Site
Chatsworth, Durban, KwaZulu-Natal, South Africa
Research Site
eManzimtoti, KwaZulu-Natal, South Africa
Research Site
Observatory, Western Cape, South Africa
Research Site
Paarl, Western Cape, South Africa
Research Site
Parow, Western Cape, South Africa
Research Site
Somerset West, Western Cape, South Africa
Research Site
Bloemfontein, , South Africa
Countries
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References
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Toth PP, Sattar N, Blom DJ, Martin SS, Jones SR, Monsalvo ML, Elliott M, Davis M, Somaratne R, Preiss D. Effect of Evolocumab on Lipoprotein Particles. Am J Cardiol. 2018 Feb 1;121(3):308-314. doi: 10.1016/j.amjcard.2017.10.028. Epub 2017 Nov 8.
Blom DJ, Koren MJ, Roth E, Monsalvo ML, Djedjos CS, Nelson P, Elliott M, Wasserman SM, Ballantyne CM, Holman RR. Evaluation of the efficacy, safety and glycaemic effects of evolocumab (AMG 145) in hypercholesterolaemic patients stratified by glycaemic status and metabolic syndrome. Diabetes Obes Metab. 2017 Jan;19(1):98-107. doi: 10.1111/dom.12788. Epub 2016 Oct 14.
Blom DJ, Djedjos CS, Monsalvo ML, Bridges I, Wasserman SM, Scott R, Roth E. Effects of Evolocumab on Vitamin E and Steroid Hormone Levels: Results From the 52-Week, Phase 3, Double-Blind, Randomized, Placebo-Controlled DESCARTES Study. Circ Res. 2015 Sep 25;117(8):731-41. doi: 10.1161/CIRCRESAHA.115.307071. Epub 2015 Jul 30.
Blom DJ, Hala T, Bolognese M, Lillestol MJ, Toth PD, Burgess L, Ceska R, Roth E, Koren MJ, Ballantyne CM, Monsalvo ML, Tsirtsonis K, Kim JB, Scott R, Wasserman SM, Stein EA; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014 May 8;370(19):1809-19. doi: 10.1056/NEJMoa1316222. 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.
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.
Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.
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.
Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110109
Identifier Type: -
Identifier Source: org_study_id
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