Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Completed · Phase 3

Conditions studied: Hypercholesterolemia

In brief

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

Key facts

Study ID

NCT02304484

Run by

Amgen

People needed

770

Starts

2014-11-24

Expected to finish

2018-03-09

Last updated by the study team

2019-03-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed week 80 of study 20120153 (NCT01813422).

You may not qualify if…

• Did not complete investigational product in the 20120153 parent study
• Have an unstable medical condition, in the judgment of the investigator
• Known sensitivity to any of the products to be administered during dosing
• Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Where it is running

• Research Site — Mobile, Alabama, United States
• Research Site — Long Beach, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrance, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Munster, Indiana, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Covington, Louisiana, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Columbia, Maryland, United States
• Research Site — Bay City, Michigan, United States
• Research Site — Midland, Michigan, United States
• Research Site — Duluth, Minnesota, United States
• Research Site — Saint Cloud, Minnesota, United States
• Research Site — Columbia, Missouri, United States
• Research Site — Ridgewood, New Jersey, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Canton, Ohio, United States
• Research Site — Toledo, Ohio, United States
• Research Site — Oak Ridge, Tennessee, United States
• Research Site — Amarillo, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Wichita Falls, Texas, United States
• Research Site — La Plata, Buenos Aires, Argentina
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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