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

Primary Purpose

Dyslipidemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Algemeen Stedelijk Ziekenhuis Aalst
  • Onze Lieve Vrouw Ziekenhuis Aalst
  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
  • Imelda Ziekenhuis vzw
  • Centre Hospitalier Universitaire Brugmann
  • Cliniques universitaires de Bruxelles Hopital Erasme
  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Algemeen Ziekenhuis Sint Lucas
  • Universitair Ziekenhuis Gent
  • Medif sprl
  • Centre Hospitalier Universitaire de Tivoli
  • Centres Hospitaliers Jolimont - Hopital de Jolimont
  • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Centre Hospitalier Regional de la Citadelle
  • Algemeen Ziekenhuis Turnhout
  • Aalborg Hospital
  • Center for Clinical and Basic Research Aalborg
  • Aarhus Universitetshospital
  • Centre for Clinical and Basic Research Ballerup
  • Sydvestjysk Sygehus
  • Frederiksberg/Bispebjerg Hospitaler
  • Glostrup Hospital
  • Hvidovre Hospital
  • Amager Hospital
  • Odense Universitetssygehus
  • Sjaellands Universitetshospital, Roskilde
  • Svendborg Sygehus
  • Center for Clinical and Basic Research Vejle
  • Regionshospitalet Viborg
  • Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau
  • Hopital Louis Pasteur
  • Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve
  • Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec
  • Nouvelles Cliniques Nantaises
  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur
  • Hopital Lariboisiere
  • Hopital Pitie-Salpetriere
  • Centre Hospitalier de Pau - Hopital Francois Mitterrand
  • Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
  • Centre Hospitalier Intercommunal Haute Saone
  • Universitaets-Herzzentrum Freiburg - Bad Krozingen
  • Klinische Forschung Berlin GbR
  • Vivantes Klinikum Neukölln
  • Deutsches Rotes Kreuz Kliniken Berlin Köpenick
  • Deutsches Herzzentrum Berlin
  • Sankt-Johannes-Hospital
  • Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden
  • Ambulantes Herzzentrum Kassel
  • Universitätsklinikum Köln
  • Otto von Guericke Universität Magdeburg
  • Johannes Gutenberg Universität Mainz
  • Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden
  • Deutsches Herzzentrum München des Freistaates Bayern
  • Robert Bosch Krankenhaus
  • Universitätsklinikum Ulm
  • Forschungszentrum Ruhr
  • Helios Universitätsklinikum Wuppertal
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Azienda Ospedaliero Universitaria Careggi
  • Centro Cardiologico Monzino
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  • Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa
  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
  • Hospital Garcia de Orta, EPE
  • Centro Hospitalar e Universitario de Coimbra EPE
  • Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha
  • Hospital Cuf Infante Santo
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
  • Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo
  • Falu Lasarett
  • Helsingborgs Lasarett
  • Länssjukhuset Ryhov
  • Sunderby Sjukhus
  • Skanes Universitetssjukhus
  • Capio Citykliniken
  • Universitetssjukhuset Ã-rebro
  • Ostersunds sjukhus
  • Akardo MedSite
  • Norrlands Universitetssjukhus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evolocumab

Arm Description

Single arm study administering Evolocumab.

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced an Adverse Event
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.

Secondary Outcome Measures

Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL

Full Information

First Posted
March 10, 2017
Last Updated
March 6, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03080935
Brief Title
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Amgen business decision to close study early
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Single arm study administering Evolocumab.
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145
Intervention Description
Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced an Adverse Event
Description
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Time Frame
Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Title
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Time Frame
Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Algemeen Stedelijk Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Onze Lieve Vrouw Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Imelda Ziekenhuis vzw
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques universitaires de Bruxelles Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Medif sprl
City
Gozee
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Centres Hospitaliers Jolimont - Hopital de Jolimont
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Turnhout
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Center for Clinical and Basic Research Aalborg
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Centre for Clinical and Basic Research Ballerup
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Frederiksberg/Bispebjerg Hospitaler
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Amager Hospital
City
Kobenhavn S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Odense Universitetssygehus
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sjaellands Universitetshospital, Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Svendborg Sygehus
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Center for Clinical and Basic Research Vejle
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
City
Besancon cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Hopital Louis Pasteur
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve
City
Montpellier cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes Cedex 2
ZIP/Postal Code
44202
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalier de Pau - Hopital Francois Mitterrand
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier Intercommunal Haute Saone
City
Vesoul
ZIP/Postal Code
70014
Country
France
Facility Name
Universitaets-Herzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Klinische Forschung Berlin GbR
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Vivantes Klinikum Neukölln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Deutsches Rotes Kreuz Kliniken Berlin Köpenick
City
Berlin
ZIP/Postal Code
12559
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Sankt-Johannes-Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Ambulantes Herzzentrum Kassel
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Otto von Guericke Universität Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Johannes Gutenberg Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden
City
München
ZIP/Postal Code
80333
Country
Germany
Facility Name
Deutsches Herzzentrum München des Freistaates Bayern
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Robert Bosch Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Forschungszentrum Ruhr
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Helios Universitätsklinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Hospital Garcia de Orta, EPE
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Centro Hospitalar e Universitario de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha
City
Covilha
ZIP/Postal Code
6200-251
Country
Portugal
Facility Name
Hospital Cuf Infante Santo
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Helsingborgs Lasarett
City
Helsingborg
ZIP/Postal Code
252 47
Country
Sweden
Facility Name
Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Sunderby Sjukhus
City
Lulea
ZIP/Postal Code
971 80
Country
Sweden
Facility Name
Skanes Universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Capio Citykliniken
City
Lund
ZIP/Postal Code
222 21
Country
Sweden
Facility Name
Universitetssjukhuset Ã-rebro
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Ostersunds sjukhus
City
Ostersund
ZIP/Postal Code
831 83
Country
Sweden
Facility Name
Akardo MedSite
City
Stockholm
ZIP/Postal Code
117 27
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umea
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
36031810
Citation
O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
Results Reference
background
PubMed Identifier
36779348
Citation
Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
Results Reference
background
PubMed Identifier
28477848
Citation
Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20. No abstract available.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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

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