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

Last updated: May 10, 2024
Sponsor: Amgen
Overall Status: Terminated

Phase

3

Condition

Vascular Diseases

Dyslipidemia

Treatment

Evolocumab

Clinical Study ID

NCT03080935
20160250
2016-004066-26
  • Ages 40-85
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specificactivities/procedures.

  • Subject had completed FOURIER (Study 20110118) while still receiving assignedInvestigational Product.

Exclusion

Exclusion Criteria:

  • Permanent discontinuation of Investigational Product during FOURIER for any reasonincluding an adverse event or serious adverse event.

  • Currently receiving treatment in another investigational device or drug study, orless than 4 weeks since ending treatment on another investigational device or drugstudy(ies). Other investigational procedures while participating in this study areexcluded.

  • Subject likely to not be available to complete all protocol-required study visits orprocedures, and/or to comply with all required study procedures to the best of thesubject and investigator's knowledge.

  • History or evidence of any other clinically significant disorder, condition ordisease that, in the opinion of the investigator or Amgen physician, if consulted,would pose a risk to subject safety or interfere with the study evaluation,procedures or completion.

  • Subject has known sensitivity to any of the active substances or excipients (eg,sodium acetate) to be administered during dosing.

  • Females who are pregnant or breastfeeding or planning to become pregnant orbreastfeed during treatment with evolocumab and for an additional 15 weeks aftertreatment with evolocumab discontinues.

  • Female subjects of childbearing potential unwilling to use an acceptable method ofeffective contraception during treatment and for an additional 15 weeks after thelast dose of protocol-required therapies.

Study Design

Total Participants: 1600
Treatment Group(s): 1
Primary Treatment: Evolocumab
Phase: 3
Study Start date:
March 13, 2017
Estimated Completion Date:
March 04, 2022

Study Description

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.

All deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.

Connect with a study center

  • Algemeen Stedelijk Ziekenhuis Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • Ziekenhuis Netwerk Antwerpen Middelheim

    Antwerpen, 2020
    Belgium

    Site Not Available

  • Ziekenhuis Netwerk Antwerpen Stuivenberg

    Antwerpen, 2060
    Belgium

    Site Not Available

  • Imelda Ziekenhuis vzw

    Bonheiden, 2820
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire Brugmann

    Brussels, 1020
    Belgium

    Site Not Available

  • Cliniques universitaires de Bruxelles Hopital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Sint Lucas

    Gent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Medif sprl

    Gozee, 6534
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Tivoli

    La Louvière, 7100
    Belgium

    Site Not Available

  • Centres Hospitaliers Jolimont - Hopital de Jolimont

    La Louvière, 7100
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Tivoli

    La Louvière, 7100
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Turnhout

    Turnhout, 2300
    Belgium

    Site Not Available

  • Aalborg Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Center for Clinical and Basic Research Aalborg

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Centre for Clinical and Basic Research Ballerup

    Ballerup, 2750
    Denmark

    Site Not Available

  • Sydvestjysk Sygehus

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Frederiksberg/Bispebjerg Hospitaler

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Glostrup Hospital

    Glostrup, 2600
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Research Site

    Kobenhavn, 2400
    Denmark

    Site Not Available

  • Amager Hospital

    Kobenhavn S, 2300
    Denmark

    Site Not Available

  • Research Site

    Koge, 4600
    Denmark

    Site Not Available

  • Research Site

    København, 2400
    Denmark

    Site Not Available

  • Odense Universitetssygehus

    Odense, 5000
    Denmark

    Site Not Available

  • Research Site

    Odense C, 5000
    Denmark

    Site Not Available

  • Sjaellands Universitetshospital, Roskilde

    Roskilde, 4000
    Denmark

    Site Not Available

  • Svendborg Sygehus

    Svendborg, 5700
    Denmark

    Site Not Available

  • Center for Clinical and Basic Research Vejle

    Vejle, 7100
    Denmark

    Site Not Available

  • Regionshospitalet Viborg

    Viborg, 8800
    Denmark

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

    Besancon cedex, 25030
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau

    Chambray les Tours, 37170
    France

    Site Not Available

  • Hopital Louis Pasteur

    Le Coudray, 28630
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve

    Montpellier cedex 05, 34295
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Nouvelles Cliniques Nantaises

    Nantes Cedex 2, 44202
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice, 06000
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris, 75010
    France

    Site Not Available

  • Hopital Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Centre Hospitalier de Pau - Hopital Francois Mitterrand

    Pau, 64000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

    Reims, 51100
    France

    Site Not Available

  • Research Site

    Reims cedex, 51092
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Centre Hospitalier Intercommunal Haute Saone

    Vesoul, 70014
    France

    Site Not Available

  • Universitaets-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189
    Germany

    Site Not Available

  • Deutsches Herzzentrum Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Deutsches Rotes Kreuz Kliniken Berlin Köpenick

    Berlin, 12559
    Germany

    Site Not Available

  • Klinische Forschung Berlin GbR

    Berlin, 10787
    Germany

    Site Not Available

  • Vivantes Klinikum Neukölln

    Berlin, 12351
    Germany

    Site Not Available

  • Sankt-Johannes-Hospital

    Dortmund, 44137
    Germany

    Site Not Available

  • Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Ambulantes Herzzentrum Kassel

    Kassel, 34121
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, 50937
    Germany

    Site Not Available

  • Otto von Guericke Universität Magdeburg

    Magdeburg, 39120
    Germany

    Site Not Available

  • Johannes Gutenberg Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, 80636
    Germany

    Site Not Available

  • Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden

    München, 80333
    Germany

    Site Not Available

  • Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden

    München, 80333
    Germany

    Site Not Available

  • Robert Bosch Krankenhaus

    Stuttgart, 70376
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Forschungszentrum Ruhr

    Witten, 58455
    Germany

    Site Not Available

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42117
    Germany

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Careggi

    Firenze, 50139
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Centro Cardiologico Monzino

    Milano, 20138
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06129
    Italy

    Site Not Available

  • Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa

    Pisa, 56124
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100
    Italy

    Site Not Available

  • Hospital Garcia de Orta, EPE

    Almada, 2801-951
    Portugal

    Site Not Available

  • Centro Hospitalar e Universitario de Coimbra EPE

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha

    Covilha, 6200-251
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier

    Lisboa, 1449-005
    Portugal

    Site Not Available

  • Hospital Cuf Infante Santo

    Lisboa, 1350-352
    Portugal

    Site Not Available

  • Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo

    Setubal, 2910-446
    Portugal

    Site Not Available

  • Falu Lasarett

    Falun, 791 82
    Sweden

    Site Not Available

  • Helsingborgs Lasarett

    Helsingborg, 252 47
    Sweden

    Site Not Available

  • Länssjukhuset Ryhov

    Jönköping, 551 85
    Sweden

    Site Not Available

  • Länssjukhuset Ryhov

    Jönköping, 551 85
    Sweden

    Site Not Available

  • Sunderby Sjukhus

    Lulea, 971 80
    Sweden

    Site Not Available

  • Capio Citykliniken

    Lund, 222 21
    Sweden

    Site Not Available

  • Skanes Universitetssjukhus

    Lund, 221 85
    Sweden

    Site Not Available

  • Universitetssjukhuset Ã-rebro

    Orebro, 701 85
    Sweden

    Site Not Available

  • Ostersunds sjukhus

    Ostersund, 831 83
    Sweden

    Site Not Available

  • Akardo MedSite

    Stockholm, 117 27
    Sweden

    Site Not Available

  • Norrlands Universitetssjukhus

    Umea, 901 85
    Sweden

    Site Not Available

  • Research Site

    Östersund, 831 83
    Sweden

    Site Not Available

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