Status:
COMPLETED
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Lead Sponsor:
Amgen
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Completed week 80 of study 20120153 (NCT01813422).
Exclusion
- 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)
Key Trial Info
Start Date :
November 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2018
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT02304484
Start Date
November 24 2014
End Date
March 9 2018
Last Update
March 19 2019
Active Locations (126)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Mobile, Alabama, United States, 36608
3
Research Site
Long Beach, California, United States, 90822
4
Research Site
San Diego, California, United States, 92161