Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
NCT ID: NCT01763905
Last Updated: 2020-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
307 participants
INTERVENTIONAL
2013-01-24
2013-11-19
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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Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Placebo to Evolocumab
Subcutaneous injection
Ezetimibe
Tablet for oral administration
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Placebo to Evolocumab
Subcutaneous injection
Ezetimibe
Tablet for oral administration
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
Subcutaneous injection
Placebo to Ezetimibe
Tablet for oral administration
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
Subcutaneous injection
Placebo to Ezetimibe
Tablet for oral administration
Interventions
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Evolocumab
Subcutaneous injection
Placebo to Evolocumab
Subcutaneous injection
Ezetimibe
Tablet for oral administration
Placebo to Ezetimibe
Tablet for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not on a statin or on a low dose statin with stable dose for at least 4 weeks
* History of intolerance to at least 2 statins
* Subject not at LDL-C goal
* Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
* Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* 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
Carmichael, California, United States
Research Site
Los Angeles, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Thousand Oaks, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Auburn, Maine, United States
Research Site
Traverse City, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Henderson, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Houston, Texas, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Milton, Queensland, Australia
Research Site
Melbourne, Victoria, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
La Louvière, , Belgium
Research Site
Newmarket, Ontario, Canada
Research Site
Lachine, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Lille, , France
Research Site
Paris, , France
Research Site
Vénissieux, , France
Research Site
Bad Krozingen, , Germany
Research Site
Dresden, , Germany
Research Site
Heppenheim an der Bergstrasse, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
New Territories, , Hong Kong
Research Site
Alkmaar, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Groningen, , Netherlands
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Midrand, Gauteng, South Africa
Research Site
Observatory, Western Cape, South Africa
Research Site
Somerset West, Western Cape, South Africa
Research Site
Córdoba, Andalusia, Spain
Research Site
Zaragoza, Aragon, Spain
Research Site
Reus, Catalonia, Spain
Research Site
Lugano, , Switzerland
Research Site
Reinach, , Switzerland
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Telford, , United Kingdom
Research Site
West Bromwich, , United Kingdom
Countries
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References
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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, 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.
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.
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.
Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.
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.
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.
Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, Xue A, Scott R, Wasserman SM, Stroes E. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014 Mar;37(3):131-9. doi: 10.1002/clc.22248. Epub 2014 Jan 29.
Stroes E, Colquhoun D, Sullivan D, Civeira F, Rosenson RS, Watts GF, Bruckert E, Cho L, Dent R, Knusel B, Xue A, Scott R, Wasserman SM, Rocco M; GAUSS-2 Investigators. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2541-2548. doi: 10.1016/j.jacc.2014.03.019. Epub 2014 Mar 30.
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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-001364-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110116
Identifier Type: -
Identifier Source: org_study_id
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