NCT02867813

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,035 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.

Timeline

• Start date: 2016-09-02
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2016-08-16
• Last updated: 2023-04-07
• Results posted: 2023-02-28

Locations

198 sites across 7 countries: United States, Czechia, Hungary, Poland, Russia, Slovakia, Ukraine