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Study Complete
Sponsor ID
20140128

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

Sponsor ID
20140128
Clinicaltrials.gov ID
NCT02304484
EUCTIS ID
N/A
EudraCT ID
2014-001524-30
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
770
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: after all subjects complete week 52

Secondary Outcome Measures

Low density lipoprotein cholesterol (LDL-C) at week 52

Timeframe: after week 52 for all subjects

Locations

Location
Status
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Location
Research Site
Budapest, Hungary, 1122
Status
Recruiting
Location
Research Site
Covington, LA, United States, 70433
Status
Recruiting
Location
Research Site
Midland, MI, United States, 48670
Status
Recruiting
Location
Research Site
Rozzano MI, Italy, 20089
Status
Recruiting
Location
Research Site
Szeged, Hungary, 6725
Status
Recruiting
Location
Research Site
Wichita Falls, TX, United States, 76301
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Nov 2014 - Mar 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Completed week 80 of study 20120153 (NCT01813422).
    Exclusion Criteria:
    - 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)