Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
NCT ID: NCT01879319
Last Updated: 2022-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
164 participants
INTERVENTIONAL
2013-07-11
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
NONE
Study Groups
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Evolocumab AMD
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
Evolocumab AMD
Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
Evolocumab AI/pen
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
Evolocumab AI/pen
Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
Interventions
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Evolocumab AMD
Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
Evolocumab AI/pen
Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes or 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
Phoenix, Arizona, United States
Research Site
Encino, California, United States
Research Site
Thousand Oaks, California, United States
Research Site
Tustin, California, United States
Research Site
Ventura, California, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Saint Augustine, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Gainesville, Georgia, United States
Research Site
Lexington, Kentucky, United States
Research Site
Lewiston, Maine, United States
Research Site
Ayer, Massachusetts, United States
Research Site
Manlius, New York, United States
Research Site
Cadiz, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Lansdale, Pennsylvania, United States
Research Site
Jackson, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Burnaby, British Columbia, Canada
Research Site
London, Ontario, Canada
Research Site
Sarnia, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Pointe-Claire, Quebec, Canada
Countries
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References
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Boccara F, Dent R, Ruilope L, Valensi P. Practical Considerations for the Use of Subcutaneous Treatment in the Management of Dyslipidaemia. Adv Ther. 2017 Aug;34(8):1876-1896. doi: 10.1007/s12325-017-0586-8. Epub 2017 Jul 17.
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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120356
Identifier Type: -
Identifier Source: org_study_id
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