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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT03080935
Collaborator
(none)
1,600
Enrollment
85
Locations
1
Arm
59.6
Actual Duration (Months)
18.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open label
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
Actual Study Start Date :
Mar 13, 2017
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Evolocumab

Single arm study administering Evolocumab.

Drug: Evolocumab
Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Other Names:
  • AMG 145

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse event measurement [5 years]

      The primary endpoint is the subject incidence of adverse events. Subject safety will be measured by tracking adverse events.

    Secondary Outcome Measures

    1. Percent change of LDL-C [5 years]

      The secondary end point is the percent change of LDL-C from baseline at each scheduled visit.

    2. Achievement of an LDL-C < 40 mg/dL [5 years]

      The achievement of an LDL-C < 40 mg/dL (1.03 mmol/L) at each scheduled visit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

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

    Exclusion Criteria:

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

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

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

    • History or evidence of any other clinically significant disorder, condition or disease 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 or breastfeed during treatment with evolocumab and for an additional 15 weeks after treatment with evolocumab discontinues.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Algemeen Stedelijk Ziekenhuis Aalst Aalst Belgium 9300
    2 Onze Lieve Vrouw Ziekenhuis Aalst Aalst Belgium 9300
    3 Ziekenhuis Netwerk Antwerpen Middelheim Antwerpen Belgium 2020
    4 Ziekenhuis Netwerk Antwerpen Stuivenberg Antwerpen Belgium 2060
    5 Imelda Ziekenhuis vzw Bonheiden Belgium 2820
    6 Centre Hospitalier Universitaire Brugmann Brussels Belgium 1020
    7 Cliniques universitaires de Bruxelles Hopital Erasme Brussels Belgium 1070
    8 Universite Catholique de Louvain Cliniques Universitaires Saint Luc Bruxelles Belgium 1200
    9 Algemeen Ziekenhuis Sint Lucas Gent Belgium 9000
    10 Universitair Ziekenhuis Gent Gent Belgium 9000
    11 Medif sprl Gozee Belgium 6534
    12 Centre Hospitalier Universitaire de Tivoli La Louvière Belgium 7100
    13 Centres Hospitaliers Jolimont - Hopital de Jolimont La Louvière Belgium 7100
    14 Centre Hospitalier Universitaire de Liege - Sart Tilman Liege Belgium 4000
    15 Centre Hospitalier Regional de la Citadelle Liège Belgium 4000
    16 Algemeen Ziekenhuis Turnhout Turnhout Belgium 2300
    17 Aalborg Hospital Aalborg Denmark 9000
    18 Center for Clinical and Basic Research Aalborg Aalborg Denmark 9000
    19 Aarhus Universitetshospital Aarhus N Denmark 8200
    20 Centre for Clinical and Basic Research Ballerup Ballerup Denmark 2750
    21 Sydvestjysk Sygehus Esbjerg Denmark 6700
    22 Frederiksberg/Bispebjerg Hospitaler Frederiksberg Denmark 2000
    23 Glostrup Hospital Glostrup Denmark 2600
    24 Hvidovre Hospital Hvidovre Denmark 2650
    25 Amager Hospital Kobenhavn S Denmark 2300
    26 Odense Universitetssygehus Odense Denmark 5000
    27 Sjaellands Universitetshospital, Roskilde Roskilde Denmark 4000
    28 Svendborg Sygehus Svendborg Denmark 5700
    29 Center for Clinical and Basic Research Vejle Vejle Denmark 7100
    30 Regionshospitalet Viborg Viborg Denmark 8800
    31 Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz Besancon cedex France 25030
    32 Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau Chambray les Tours France 37170
    33 Hopital Louis Pasteur Le Coudray France 28630
    34 Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve Montpellier cedex 05 France 34295
    35 Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec Nantes Cedex 1 France 44093
    36 Nouvelles Cliniques Nantaises Nantes Cedex 2 France 44202
    37 Centre Hospitalier Universitaire de Nice - Hopital Pasteur Nice France 06000
    38 Hopital Lariboisiere Paris France 75010
    39 Hopital Pitie-Salpetriere Paris France 75013
    40 Centre Hospitalier de Pau - Hopital Francois Mitterrand Pau France 64000
    41 Centre Hospitalier Universitaire de Reims - Hopital Robert Debre Reims France 51100
    42 Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil Toulouse Cedex 9 France 31059
    43 Centre Hospitalier Intercommunal Haute Saone Vesoul France 70014
    44 Universitaets-Herzzentrum Freiburg - Bad Krozingen Bad Krozingen Germany 79189
    45 Klinische Forschung Berlin GbR Berlin Germany 10787
    46 Vivantes Klinikum Neukölln Berlin Germany 12351
    47 Deutsches Rotes Kreuz Kliniken Berlin Köpenick Berlin Germany 12559
    48 Deutsches Herzzentrum Berlin Berlin Germany 13353
    49 Sankt-Johannes-Hospital Dortmund Germany 44137
    50 Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden Dresden Germany 01307
    51 Ambulantes Herzzentrum Kassel Kassel Germany 34121
    52 Universitätsklinikum Köln Köln Germany 50937
    53 Otto von Guericke Universität Magdeburg Magdeburg Germany 39120
    54 Johannes Gutenberg Universität Mainz Mainz Germany 55131
    55 Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden München Germany 80333
    56 Deutsches Herzzentrum München des Freistaates Bayern München Germany 80636
    57 Robert Bosch Krankenhaus Stuttgart Germany 70376
    58 Universitätsklinikum Ulm Ulm Germany 89081
    59 Forschungszentrum Ruhr Witten Germany 58455
    60 Helios Universitätsklinikum Wuppertal Wuppertal Germany 42117
    61 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Italy 24127
    62 Azienda Ospedaliero Universitaria Careggi Firenze Italy 50139
    63 Centro Cardiologico Monzino Milano Italy 20138
    64 Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    65 Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Palermo Italy 90146
    66 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100
    67 Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia Perugia Italy 06129
    68 Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa Pisa Italy 56124
    69 Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte Siena Italy 53100
    70 Hospital Garcia de Orta, EPE Almada Portugal 2801-951
    71 Centro Hospitalar e Universitario de Coimbra EPE Coimbra Portugal 3000-075
    72 Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha Covilha Portugal 6200-251
    73 Hospital Cuf Infante Santo Lisboa Portugal 1350-352
    74 Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier Lisboa Portugal 1449-005
    75 Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo Setubal Portugal 2910-446
    76 Falu Lasarett Falun Sweden 791 82
    77 Helsingborgs Lasarett Helsingborg Sweden 252 47
    78 Länssjukhuset Ryhov Jönköping Sweden 551 85
    79 Sunderby Sjukhus Lulea Sweden 971 80
    80 Skanes Universitetssjukhus Lund Sweden 221 85
    81 Capio Citykliniken Lund Sweden 222 21
    82 Universitetssjukhuset Ã-rebro Orebro Sweden 701 85
    83 Ostersunds sjukhus Ostersund Sweden 831 83
    84 Akardo MedSite Stockholm Sweden 117 27
    85 Norrlands Universitetssjukhus Umea Sweden 901 85

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT03080935
    Other Study ID Numbers:
    • 20160250
    • 2016-004066-26
    First Posted:
    Mar 15, 2017
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Dyslipidemias
    Evolocumab

    Study Results

    No Results Posted as of Mar 10, 2022