- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879319
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
November 4, 2022 updated by: Amgen
A Multicenter, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Burnaby, British Columbia, Canada, V5G 1T4
- Research Site
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Ontario
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London, Ontario, Canada, N5W 6A2
- Research Site
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Sarnia, Ontario, Canada, N7T 4X3
- Research Site
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Toronto, Ontario, Canada, M9V 4B4
- Research Site
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Quebec
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Pointe-Claire, Quebec, Canada, H9R 3J1
- Research Site
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Arizona
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Phoenix, Arizona, United States, 85020
- Research Site
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California
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Encino, California, United States, 91436
- Research Site
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Thousand Oaks, California, United States, 91360
- Research Site
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Tustin, California, United States, 92780
- Research Site
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Ventura, California, United States, 93003
- Research Site
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Florida
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Port Charlotte, Florida, United States, 33952
- Research Site
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Saint Augustine, Florida, United States, 32086
- Research Site
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Georgia
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Atlanta, Georgia, United States, 30328
- Research Site
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Atlanta, Georgia, United States, 30342
- Research Site
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Gainesville, Georgia, United States, 30501
- Research Site
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Kentucky
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Lexington, Kentucky, United States, 40504
- Research Site
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Maine
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Lewiston, Maine, United States, 04240
- Research Site
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Massachusetts
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Ayer, Massachusetts, United States, 01432
- Research Site
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New York
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Manlius, New York, United States, 13104
- Research Site
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Ohio
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Cadiz, Ohio, United States, 43907
- Research Site
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Marion, Ohio, United States, 43302
- Research Site
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Research Site
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Lansdale, Pennsylvania, United States, 19446
- Research Site
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Tennessee
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Jackson, Tennessee, United States, 38305
- Research Site
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Nashville, Tennessee, United States, 37203
- Research Site
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Texas
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Austin, Texas, United States, 78731
- Research Site
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Dallas, Texas, United States, 75231
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fasting LDL-C at screening > 85 mg/dL
- Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes or poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
Other Names:
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EXPERIMENTAL: 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.
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Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8
Time Frame: Weeks 4 and 8
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Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8.
Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
Results only include full administrations that occurred inside the prespecified visit window.
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Weeks 4 and 8
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
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Baseline and Weeks 10 and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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, 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 11, 2013
Primary Completion (ACTUAL)
November 15, 2013
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 14, 2013
First Posted (ESTIMATE)
June 17, 2013
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Immunologic Factors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Antibodies, Monoclonal
- Evolocumab
Other Study ID Numbers
- 20120356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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