Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

Completed · Phase 3

Conditions studied: Primary Hypercholesterolemia, Mixed Dyslipidemia

In brief

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).

Key facts

Study ID

NCT01879319

Run by

Amgen

People needed

164

Starts

2013-07-11

Last updated by the study team

2022-11-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fasting LDL-C at screening > 85 mg/dL
• Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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