Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe 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 home-use using either a pre-filled syringe or autoinjector/pen.

Key facts

Study ID

NCT01849497

Run by

Amgen

People needed

149

Starts

2013-04-18

Last updated by the study team

2018-11-29

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) 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

Where it is running

• Research Site — Encino, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Ventura, California, United States
• Research Site — Westlake Village, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Port Charlotte, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Hammond, Indiana, United States
• Research Site — Auburn, Maine, United States
• Research Site — Manlius, New York, United States
• Research Site — Syracuse, New York, United States
• Research Site — Cadiz, Ohio, United States
• Research Site — Marion, Ohio, United States
• Research Site — Hillsboro, Oregon, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Lansdale, Pennsylvania, United States
• Research Site — Rapid City, South Dakota, United States
• Research Site — Jackson, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — London, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Woodstock, Ontario, Canada

Full record on ClinicalTrials.gov

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