Open Label Study of Long Term Evaluation Against LDL-C Trial

Completed · Phase 2

Conditions studied: Hypercholesterolemia

In brief

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Key facts

Study ID

NCT01439880

Run by

Amgen

People needed

1324

Starts

2011-10-07

Expected to finish

2018-06-20

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)

You may not qualify if…

• Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the 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 — Birmingham, Alabama, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Malvern, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Carmichael, California, United States
• Research Site — Inglewood, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Tustin, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Littleton, Colorado, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Green Cove Springs, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Ponte Vedra, Florida, United States
• Research Site — Port Charlotte, Florida, United States
• Research Site — Sanford, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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