Study Complete
Sponsor ID
20130295

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

Sponsor ID
20130295
Clinicaltrials.gov ID
NCT02867813
EUCTIS ID
N/A
EudraCT ID
2015-004780-36

Study Details

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).

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
5035
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of adverse events

Timeframe: 5 years

Secondary Outcome Measures

Percent change of LDL-C from baseline at each scheduled visit

Timeframe: 5 years

Achieve an LDL-C < 40 mg/dL (1.03 mmol/L) at each scheduled visit

Timeframe: 5 years

Locations

Location
Status
Contact Us
Location
Research Site
Belleville, IL, United States, 62220
Status
Completed
Location
Research Site
Addison, IL, United States, 60101
Status
Recruiting
Location
Research Site
Athens, GA, United States, 30606
Status
Recruiting
Location
Research Site
Atlanta, GA, United States, 30342
Status
Recruiting
Location
Research Site
Aurora, CO, United States, 80012
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78758
Status
Recruiting
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