Chart Review of Repatha® in Subjects With Hyperlipidaemia (HEYMANS)

June 4, 2024 updated by: Amgen

Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia

Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.

Study Overview

Status

Status

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

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.

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.
Observational

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.
1986

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

  • Austria
      • Feldkirch, Austria, 6800
        • Research Site
      • Graz, Austria, 8036
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Klagenfurt, Austria, 9020
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Salzburg, Austria, 5020
        • Research Site
      • Villach, Austria, 9500
        • Research Site
      • Wien, Austria, 1130
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Wien, Austria, 1160
        • Research Site
      • Wien, Austria, 1060
        • Research Site
  • Belgium
      • Aalst, Belgium, 9300
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • La Louvière, Belgium, 7100
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Bulgaria
      • Kostenets, Bulgaria, 2042
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4003
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
      • Sofia, Bulgaria, 1750
        • Research Site
      • Sofia, Bulgaria, 1142
        • Research Site
      • Sofia, Bulgaria, 1309
        • Research Site
      • Sofia, Bulgaria, 1113
        • Research Site
      • Sofia, Bulgaria, 1680
        • Research Site
      • Stara Zagora, Bulgaria, 6003
        • Research Site
      • Varna, Bulgaria, 9002
        • Research Site
      • Varna, Bulgaria, 9020
        • Research Site
  • Czechia
      • Brno, Czechia, 656 91
        • Research Site
      • Ceske Budejovice, Czechia, 370 01
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Liberec, Czechia, 460 63
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Plzen, Czechia, 305 99
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
      • Usti nad Labem, Czechia, 401 13
        • Research Site
      • Zlin, Czechia, 762 75
        • Research Site
  • Germany
      • Aachen, Germany, 52074
        • Research Site
      • Bad Reichenhall, Germany, 83435
        • Research Site
      • Berlin, Germany, 12627
        • Research Site
      • Berlin, Germany, 13353
        • Research Site
      • Bielefeld, Germany, 33602
        • Research Site
      • Bochum, Germany, 44787
        • Research Site
      • Borsdorf, Germany, 04451
        • Research Site
      • Detmold, Germany, 32756
        • Research Site
      • Garbsen, Germany, 30823
        • Research Site
      • Germering, Germany, 82110
        • Research Site
      • Göttingen, Germany, 37075
        • Research Site
      • Halberstadt, Germany, 38820
        • Research Site
      • Halle (Saale), Germany, 06120
        • Research Site
      • Hamburg, Germany, 20095
        • Research Site
      • Langenhagen, Germany, 30851
        • Research Site
      • Leipzig, Germany, 04317
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
      • Mannheim, Germany, 68165
        • Research Site
      • Markleeberg, Germany, 04416
        • Research Site
      • Muenchen, Germany, 80331
        • Research Site
      • Mönchengladbach, Germany, 41063
        • Research Site
      • Mühldorf, Germany, 84453
        • Research Site
      • Mülheim an der Ruhr, Germany, 45468
        • Research Site
      • München, Germany, 80331
        • Research Site
      • München, Germany, 80638
        • Research Site
      • Neuwied, Germany, 56564
        • Research Site
      • Nürnberg, Germany, 90443
        • Research Site
      • Oschatz, Germany, 04758
        • Research Site
      • Pirna, Germany, 01796
        • Research Site
      • Potsdam, Germany, 14471
        • Research Site
      • Rostock, Germany, 18059
        • Research Site
      • Rotenburg, Germany, 27356
        • Research Site
      • Viersen-Dülken, Germany, 41751
        • Research Site
      • Villingen-Schwenningen, Germany, 78052
        • Research Site
      • Zwickau, Germany, 08060
        • Research Site
  • Greece
      • Alexandroupoli, Greece, 68100
        • Research Site
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 16673
        • Research Site
      • Athens, Greece, 12462
        • Research Site
      • Athens, Greece, 14233
        • Research Site
      • Athens, Greece, 10676
        • Research Site
      • Athens, Greece, 11521
        • Research Site
      • Athens, Greece, 11526
        • Research Site
      • Athens, Greece, 14561
        • Research Site
      • Athens, Greece, 17674
        • Research Site
      • Heraklion, Greece, 71110
        • Research Site
      • Ioannina, Greece, 45500
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Piraeus, Greece, 18536
        • Research Site
      • Thessaloniki, Greece, 54636
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
      • Thessaloniki, Greece, 56403
        • Research Site
  • Italy
      • Acerra, Italy
        • Research Site
      • Arzignano, Italy, 36071
        • Research Site
      • Asti, Italy, 14100
        • Research Site
      • Bassano Del Grappa (VI), Italy, 36061
        • Research Site
      • Bologna, Italy, 40133
        • Research Site
      • Brescia, Italy, 25123
        • Research Site
      • Brindisi, Italy, 72100
        • Research Site
      • Catanzaro, Italy, 88100
        • Research Site
      • Cinisello Balsamo (MI), Italy, 20092
        • Research Site
      • Cona FE, Italy, 44124
        • Research Site
      • Cosenza, Italy, 87100
        • Research Site
      • Foggia, Italy, 71100
        • Research Site
      • Lido Di Camaiore LU, Italy, 55041
        • Research Site
      • Messina, Italy, 89125
        • Research Site
      • Mestre (VE), Italy, 30174
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Milano, Italy, 20138
        • Research Site
      • Milano, Italy, 20142
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Palermo, Italy, 90127
        • Research Site
      • Pescara, Italy, 65100
        • Research Site
      • Reggio Calabria, Italy, 89124
        • Research Site
      • Rivoli, Italy, 10098
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Roma, Italy, 00161
        • Research Site
      • Salerno, Italy, 84131
        • Research Site
      • Seriate, Italy, 24068
        • Research Site
      • Sesto San Giovanni (MI), Italy, 20099
        • Research Site
      • Taranto, Italy, 74100
        • Research Site
      • Torrette Di Ancona, Italy, 60126
        • Research Site
      • Treviglio (BG), Italy, 24047
        • Research Site
      • Trieste, Italy, 34125
        • Research Site
  • Portugal
      • Almada, Portugal, 2801-951
        • Research Site
      • Carnaxide, Portugal, 2790-134
        • Research Site
      • Coimbra, Portugal, 3000-075
        • Research Site
      • Faro, Portugal, 8000-386
        • Research Site
      • Matosinhos, Portugal, 4464-513
        • Research Site
      • Porto, Portugal, 4099-001
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bratislava, Slovakia, 826 06
        • Research Site
      • Bratislava, Slovakia, 833 48
        • Research Site
      • Bratislava, Slovakia, 831 01
        • Research Site
      • Bratislava, Slovakia, 813 69
        • Research Site
      • Bratislava, Slovakia, 831 06
        • Research Site
      • Brezno, Slovakia, 977 42
        • Research Site
      • Handlova, Slovakia, 972 51
        • Research Site
      • Komarno, Slovakia, 945 01
        • Research Site
      • Kosice, Slovakia, 040 01
        • Research Site
      • Kosice, Slovakia, 040 22
        • Research Site
      • Martin, Slovakia, 036 01
        • Research Site
      • Martin, Slovakia, 036 59
        • Research Site
      • Moldava nad Bodvou, Slovakia, 045 01
        • Research Site
      • Myjava, Slovakia, 907 01
        • Research Site
      • Namestovo, Slovakia, 029 01
        • Research Site
      • Nitra, Slovakia, 949 01
        • Research Site
      • Nitra, Slovakia, 950 01
        • Research Site
      • Nitra, Slovakia, 949 88
        • Research Site
      • Nove Mesto nad Vahom, Slovakia, 915 01
        • Research Site
      • Nove Zamky, Slovakia, 940 01
        • Research Site
      • Poprad, Slovakia, 058 01
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Roznava, Slovakia, 048 01
        • Research Site
      • Trnava, Slovakia, 917 01
        • Research Site
      • Zilina, Slovakia, 010 01
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28006
        • Research Site
    • Andalucía
      • Cadiz, Andalucía, Spain, 11009
        • Research Site
      • Huelva, Andalucía, Spain, 21080
        • Research Site
      • Jaen, Andalucía, Spain, 23007
        • Research Site
      • Malaga, Andalucía, Spain, 29010
        • Research Site
      • Sevilla, Andalucía, Spain, 41013
        • Research Site
      • Sevilla, Andalucía, Spain, 41009
        • Research Site
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07010
        • Research Site
    • Cataluña
      • Badalona, Cataluña, Spain, 08916
        • Research Site
      • Barcelona, Cataluña, Spain, 08041
        • Research Site
      • Reus, Cataluña, Spain, 43204
        • Research Site
      • Sabadell, Cataluña, Spain, 08208
        • Research Site
    • Galicia
      • Ferrol, Galicia, Spain, 15405
        • Research Site
      • Lugo, Galicia, Spain, 27003
        • Research Site
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Malmo, Sweden, 205 02
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Uppsala, Sweden, 751 85
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Research Site
      • Geneva 14, Switzerland, 1211
        • Research Site
      • Lugano, Switzerland, 6900
        • Research Site
      • Winterthur, Switzerland, 8401
        • Research Site
      • Zurich, Switzerland, 8063
        • Research Site
      • Zurich, Switzerland, 8091
        • Research Site

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population comprises patients from European countries, who have received Repatha® as part of routine clinical management of their hyperlipidaemia, between August 2015 and June 2021.

Description

Inclusion Criteria:

Adults (>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha®

Exclusion Criteria:

Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha® Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1
To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).

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
Description of clinical characteristics of subjects initiated on Repatha®
Time Frame: Study day 1
Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance
Study day 1

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
Measure Description
Time Frame
Describe LDL-C and other cholesterol values over time
Time Frame: Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha®
Detail all cholesterol assessments recorded during the observation period (Total Cholesterol, LDL-C, HDL-C, Non-HDL-C and Triglycerides).
Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha®
Describe Repatha® dose over time
Time Frame: From the first dose of Repatha® up to 30 months post first dose
Record Repatha® dose in mg
From the first dose of Repatha® up to 30 months post first dose
Describe use of other lipid-modifying therapies
Time Frame: From the first dose of Repatha® up to 30 months post first dose
Describe lipid-modifying therapies over time, type, dose and dose frequency during the observation period
From the first dose of Repatha® up to 30 months post first dose
Describe Physician visits
Time Frame: From the first dose of Repatha® up to 30 months post first dose
Collection of all primary and secondary healthcare visit dates and classification as to cardiovascular and non-cardiovascular.
From the first dose of Repatha® up to 30 months post first dose
Describe hospitalizations
Time Frame: From the first dose of Repatha® up to 30 months post first dose
Detail all hospitalizations from enrolment to end of study
From the first dose of Repatha® up to 30 months post first dose
Describe Repatha® dose frequency over time
Time Frame: From the first dose of Repatha® up to 30 months post first dose
Record dose frequency (Q2W, QM)
From the first dose of Repatha® up to 30 months post first dose
Describe Repatha® administrative device use over time
Time Frame: From the first dose of Repatha® up to 30 months post first dose
Record Repatha® administration device details, personal injector, autoinjector or pre-filled syringe throughout the observation period
From the first dose of Repatha® up to 30 months post first dose

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.
May 4, 2016

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.
June 30, 2021

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.
June 30, 2021

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).
April 27, 2016

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.
May 10, 2016

First Posted (Estimated)

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.
May 12, 2016

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.
June 6, 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.
June 4, 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.
June 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 20130296

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

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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