Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

Completed · Phase 3

Conditions studied: Dyslipidemia

In brief

The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).

Key facts

Study ID: NCT02867813
Run by: Amgen
People needed: 5035
Starts: 2016-09-02
Expected to finish: 2022-03-21
Last updated by the study team: 2023-04-07

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has provided informed consent before initiation of any study-specific activities/procedures
Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.

You may not qualify if…

Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded

Where it is running

Research Site — Huntsville, Alabama, United States
Research Site — Phoenix, Arizona, United States
Research Site — Banning, California, United States
Research Site — Long Beach, California, United States
Research Site — Oceanside, California, United States
Research Site — Oxnard, California, United States
Research Site — Palm Springs, California, United States
Research Site — Roseville, California, United States
Research Site — San Diego, California, United States
Research Site — San Pedro, California, United States
Research Site — Tarzana, California, United States
Research Site — Torrance, California, United States
Research Site — Valley Village, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Colorado Springs, Colorado, United States
Research Site — Denver, Colorado, United States
Research Site — Littleton, Colorado, United States
Research Site — Boynton Beach, Florida, United States
Research Site — Clearwater, Florida, United States
Research Site — Crystal River, Florida, United States
Research Site — Daytona Beach, Florida, United States
Research Site — Hollywood, Florida, United States
Research Site — Hollywood, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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