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

May 10, 2024 updated by: Amgen

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lieve Vrouw Ziekenhuis Aalst
      • Aalst, Belgium, 9300
        • Algemeen Stedelijk Ziekenhuis Aalst
      • Antwerpen, Belgium, 2060
        • Ziekenhuis Netwerk Antwerpen Stuivenberg
      • Antwerpen, Belgium, 2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis vzw
      • Brussels, Belgium, 1020
        • Centre Hospitalier Universitaire Brugmann
      • Brussels, Belgium, 1070
        • Cliniques universitaires de Bruxelles Hopital Erasme
      • Bruxelles, Belgium, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Gent, Belgium, 9000
        • Algemeen Ziekenhuis Sint Lucas
      • Gozee, Belgium, 6534
        • Medif sprl
      • La Louvière, Belgium, 7100
        • Centre Hospitalier Universitaire de Tivoli
      • La Louvière, Belgium, 7100
        • Centres Hospitaliers Jolimont - Hopital de Jolimont
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege - Sart Tilman
      • Liège, Belgium, 4000
        • Centre Hospitalier Régional de la Citadelle
      • Turnhout, Belgium, 2300
        • Algemeen Ziekenhuis Turnhout
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Hospital
      • Aalborg, Denmark, 9000
        • Center for Clinical and Basic Research Aalborg
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital
      • Ballerup, Denmark, 2750
        • Centre for Clinical and Basic Research Ballerup
      • Esbjerg, Denmark, 6700
        • Sydvestjysk Sygehus
      • Frederiksberg, Denmark, 2000
        • Frederiksberg/Bispebjerg Hospitaler
      • Glostrup, Denmark, 2600
        • Glostrup Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Kobenhavn S, Denmark, 2300
        • Amager Hospital
      • Odense, Denmark, 5000
        • Odense Universitetssygehus
      • Roskilde, Denmark, 4000
        • Sjaellands Universitetshospital, Roskilde
      • Svendborg, Denmark, 5700
        • Svendborg Sygehus
      • Vejle, Denmark, 7100
        • Center for Clinical and Basic Research Vejle
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg
  • France
      • Besancon cedex, France, 25030
        • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
      • Chambray les Tours, France, 37170
        • Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau
      • Le Coudray, France, 28630
        • Hopital Louis Pasteur
      • Montpellier cedex 05, France, 34295
        • Centre Hospitalier Régional Universitaire de Montpellier - Hôpital Arnaud de Villeneuve
      • Nantes Cedex 1, France, 44093
        • Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec
      • Nantes Cedex 2, France, 44202
        • Nouvelles Cliniques Nantaises
      • Nice, France, 06000
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Pau, France, 64000
        • Centre Hospitalier de Pau - Hôpital François Mitterrand
      • Reims, France, 51100
        • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré
      • Toulouse Cedex 9, France, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
      • Vesoul, France, 70014
        • Centre Hospitalier Intercommunal Haute Saone
  • Germany
      • Bad Krozingen, Germany, 79189
        • Universitaets-Herzzentrum Freiburg - Bad Krozingen
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin
      • Berlin, Germany, 10787
        • Klinische Forschung Berlin GbR
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln
      • Berlin, Germany, 12559
        • Deutsches Rotes Kreuz Kliniken Berlin Köpenick
      • Dortmund, Germany, 44137
        • Sankt-Johannes-Hospital
      • Dresden, Germany, 01307
        • Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden
      • Kassel, Germany, 34121
        • Ambulantes Herzzentrum Kassel
      • Köln, Germany, 50937
        • Universitätsklinikum Köln
      • Magdeburg, Germany, 39120
        • Otto von Guericke Universität Magdeburg
      • Mainz, Germany, 55131
        • Johannes Gutenberg Universität Mainz
      • München, Germany, 80636
        • Deutsches Herzzentrum München des Freistaates Bayern
      • München, Germany, 80333
        • Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden
      • Stuttgart, Germany, 70376
        • Robert Bosch Krankenhaus
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
      • Witten, Germany, 58455
        • Forschungszentrum Ruhr
      • Wuppertal, Germany, 42117
        • Helios Universitätsklinikum Wuppertal
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Firenze, Italy, 50139
        • Azienda Ospedaliero Universitaria Careggi
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino
      • Milano, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Perugia, Italy, 06129
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Pisa, Italy, 56124
        • Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
  • Portugal
      • Almada, Portugal, 2801-951
        • Hospital Garcia de Orta, EPE
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar E Universitario de Coimbra EPE
      • Covilha, Portugal, 6200-251
        • Centro Hospitalar Cova da Beira, EPE - Hospital Pêro da Covilhã
      • Lisboa, Portugal, 1350-352
        • Hospital Cuf Infante Santo
      • Lisboa, Portugal, 1449-005
        • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital São Francisco Xavier
      • Setubal, Portugal, 2910-446
        • Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo
  • Sweden
      • Falun, Sweden, 791 82
        • Falu Lasarett
      • Helsingborg, Sweden, 252 47
        • Helsingborgs Lasarett
      • Jönköping, Sweden, 551 85
        • Länssjukhuset Ryhov
      • Lulea, Sweden, 971 80
        • Sunderby Sjukhus
      • Lund, Sweden, 221 85
        • Skanes universitetssjukhus
      • Lund, Sweden, 222 21
        • Capio Citykliniken
      • Orebro, Sweden, 701 85
        • Universitetssjukhuset Ã-rebro
      • Ostersund, Sweden, 831 83
        • Östersunds Sjukhus
      • Stockholm, Sweden, 117 27
        • Akardo MedSite
      • Umea, Sweden, 901 85
        • Norrlands Universitetssjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced an Adverse Event
Time Frame: Up to 5 years
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.
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
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
Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20160250
  • 2016-004066-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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