Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Sponsor
Amgen
Study ID
NCT03080935
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.

Study Details

This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).

Key Dates

Start date
Mar 13, 2017
Status verified
May 2024
Primary completion
Mar 4, 2022
Completion
Mar 4, 2022

Study Design

Enrollment
1,600 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    Single arm study administering Evolocumab.

Primary Outcome Measure

Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to 5 years ]

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