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Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension — FOURIER OLE  

Dyslipidemia Clinical Trial

Official title:
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease

Clinical Trial Summary

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).

Clinical Trial Description

This is a multicenter, open-label extension study designed to assess the long-term safety of evolocumab in subjects who completed the FOURIER study,which is a randomized placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of FOURIER study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02867813
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 3
Start date September 2, 2016
Completion date March 21, 2022
View Details
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