FOURIER-OLE
FOURIER-OLE
Project number : 254321
Created by: Karin Björling, 2018-10-23
Last revised by: Karin Björling, 2018-10-23
Project created in: Centrum för Klinisk Forskning Dalarna

PublishedPublished

Grundläggande information om projektet

Fullständig titel

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

Startdatum

2017-01-01

Beräknat slutdatum

2021-12-31

Ämnesområde

not checked Cancer
checked Cirkulation och andning
not checked Endokrinologi och metabolism
not checked Gynekologi
not checked Infektion
not checked Kirurgi
not checked Ortopedi
not checked Reumatologi
not checked Psykiatri
not checked Medicintekniska produkter
not checked Annat

Information inblandande personer och organisationer

Sammanfattning

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). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.

The FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.

Upon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.

This study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.

Inblandade organisationer

information Added workplaces
Landsting - Landstinget Dalarna - Hälso- och sjukvård - Specialiserad vård - Sjukhus - Falu lasarett - Kardiologiska kliniken - Övrigt (0 %)

Klinik

Kardiologkliniken, Falun

Typ av studie

not checked Klinisk prövning (Clinical Trial)
not checked Klinisk prövning, fas I (Clinical Trial Phase I)
not checked Klinisk prövning, fas II (Clinical Trial Phase II)
not checked Klinisk prövning, fas III (Clinical Trial Phase III)
checked Klinisk prövning, fas IV (Clinical Trial Phase IV)
not checked Icke interventionsstudie
not checked Kontrollerade kliniska prövningar (Controlled Clinical Trial)
checked Randomiserad klinisk prövning (Randomized Controlled Trial)
checked Multicenter studie
not checked Akademisk studie
not checked Annat

Sponsornamn

AMGEN

EudraCT nummer

2016-004066-26

Annat nummer, motsvarande EudraCT

20160250

Status

checked Projektet pågår
not checked Projektet avslutat

FOURIER-OLE, from Centrum för Klinisk Forskning Dalarna
http://www.researchweb.org/is/en/ckfuu/project/254321