HypercholesterolaemiaHEYMANSNCT02770131

Chart Review of Repatha® in Subjects With Hyperlipidaemia

An observational study of Hypercholesterolaemia, run by Amgen at 183 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Hypercholesterolaemia
How many people: 1,986 participants
Where: 183 sitesin 12 countries
Study dates: 4 May 2016to 30 Jun 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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®

Trial locations and contacts

183 sites in 12 countries.

Country

City, postcode or hospital

183 sites in 12 countries

Germany34 sites

Research Site
Aachen, 52074
Research Site
Bad Reichenhall, 83435
Research Site
Berlin, 12627
Research Site
Berlin, 13353
Research Site
Bielefeld, 33602
Research Site
Bochum, 44787
Research Site
Borsdorf, 04451
Research Site
Detmold, 32756
Research Site
Garbsen, 30823
Research Site
Germering, 82110
Research Site
Göttingen, 37075
Research Site
Halberstadt, 38820
Research Site
Halle, 06120
Research Site
Hamburg, 20095
Research Site
Langenhagen, 30851
Research Site
Leipzig, 04317
Research Site
Mainz, 55131
Research Site
Mannheim, 68165
Research Site
Markleeberg, 04416
Research Site
Mönchengladbach, 41063
Research Site
Mühldorf, 84453
Research Site
Mülheim, 45468
Research Site
München, 80331
Research Site
München, 80638
Research Site
Neuwied, 56564
Research Site
Nuremberg, 90443
Research Site
Oschatz, 04758
Research Site
Pirna, 01796
Research Site
Potsdam, 14471
Research Site
Rostock, 18059
Research Site
Rotenburg (Wümme), 27356
Research Site
Viersen-Dülken, 41751
Research Site
Villingen-Schwenningen, 78052
Research Site
Zwickau, 08060

Other trials in Germany

Italy33 sites

Research Site
Acerra
Research Site
Arzignano, 36071
Research Site
Asti, 14100
Research Site
Bassano Del Grappa (VI), 36061
Research Site
Bologna, 40133
Research Site
Brescia, 25123
Research Site
Brindisi, 72100
Research Site
Catanzaro, 88100
Research Site
Cinisello Balsamo (MI), 20092
Research Site
Cona FE, 44124
Research Site
Cosenza, 87100
Research Site
Foggia, 71100
Research Site
Lido Di Camaiore LU, 55041
Research Site
Messina, 89125
Research Site
Mestre (VE), 30174
Research Site
Milan, 20132
Research Site
Milan, 20138
Research Site
Milan, 20142
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Palermo, 90127
Research Site
Pescara, 65100
Research Site
Reggio Calabria, 89124
Research Site
Rivoli, 10098
Research Site
Roma, 00161
Research Site
Roma, 00168
Research Site
Salerno, 84131
Research Site
Seriate, 24068
Research Site
Sesto San Giovanni (MI), 20099
Research Site
Taranto, 74100
Research Site
Torrette Di Ancona, 60126
Research Site
Treviglio (BG), 24047
Research Site
Trieste, 34125

Other trials in Italy

Slovakia26 sites

Research Site
Banská Bystrica, 974 01
Research Site
Bratislava, 813 69
Research Site
Bratislava, 826 06
Research Site
Bratislava, 831 01
Research Site
Bratislava, 831 06
Research Site
Bratislava, 833 48
Research Site
Brezno, 977 42
Research Site
Handlová, 972 51
Research Site
Komárno, 945 01
Research Site
Košice, 040 01
Research Site
Košice, 040 22
Research Site
Martin, 036 01
Research Site
Martin, 036 59
Research Site
Moldava nad Bodvou, 045 01
Research Site
Myjava, 907 01
Research Site
Námestovo, 029 01
Research Site
Nitra, 949 01
Research Site
Nitra, 949 88
Research Site
Nitra, 950 01
Research Site
Nové Mesto nad Váhom, 915 01
Research Site
Nové Zámky, 940 01
Research Site
Poprad, 058 01
Research Site
Prešov, 080 01
Research Site
Rožňava, 048 01
Research Site
Trnava, 917 01
Research Site
Žilina, 010 01

Other trials in Slovakia

Greece17 sites

Research Site
Alexandroupoli, 68100
Research Site
Athens, 10676
Research Site
Athens, 11521
Research Site
Athens, 11526
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Athens, 14233
Research Site
Athens, 14561
Research Site
Athens, 16673
Research Site
Athens, 17674
Research Site
Heraklion, 71110
Research Site
Ioannina, 45500
Research Site
Larissa, 41110
Research Site
Piraeus, 18536
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 56403
Research Site
Thessaloniki, 56429

Other trials in Greece

Spain17 sites

Research Site
Alcalá de Henares, Madrid, 28805
Research Site
Badalona, Catalonia, 08916
Research Site
Barcelona, Catalonia, 08041
Research Site
Cadiz, Andalusia, 11009
Research Site
Ferrol, Galicia, 15405
Research Site
Huelva, Andalusia, 21080
Research Site
Jaén, Andalusia, 23007
Research Site
Lugo, Galicia, 27003
Research Site
Madrid, 28006
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Málaga, Andalusia, 29010
Research Site
Palma de Mallorca, Balearic Islands, 07010
Research Site
Reus, Catalonia, 43204
Research Site
Sabadell, Catalonia, 08208
Research Site
Seville, Andalusia, 41009
Research Site
Seville, Andalusia, 41013

Other trials in Spain

Bulgaria14 sites

Research Site
Kostenets, 2042
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4003
Research Site
Sofia, 1113
Research Site
Sofia, 1142
Research Site
Sofia, 1309
Research Site
Sofia, 1407
Research Site
Sofia, 1527
Research Site
Sofia, 1680
Research Site
Sofia, 1750
Research Site
Stara Zagora, 6003
Research Site
Varna, 9002
Research Site
Varna, 9020

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Austria11 sites

Research Site
Feldkirch, 6800
Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Klagenfurt, 9020
Research Site
Linz, 4010
Research Site
Salzburg, 5020
Research Site
Vienna, 1060
Research Site
Vienna, 1090
Research Site
Vienna, 1130
Research Site
Vienna, 1160
Research Site
Villach, 9500

Other trials in Austria

Czechia10 sites

Research Site
Brno, 656 91
Research Site
České Budějovice, 370 01
Research Site
Hradec Králové, 500 05
Research Site
Liberec, 460 63
Research Site
Olomouc, 775 20
Research Site
Pilsen, 305 99
Research Site
Prague, 140 21
Research Site
Prague, 150 06
Research Site
Ústí nad Labem, 401 13
Research Site
Zlín, 762 75

Other trials in Czechia

Portugal6 sites

Research Site
Almada, 2801-951
Research Site
Carnaxide, 2790-134
Research Site
Coimbra, 3000-075
Research Site
Faro, 8000-386
Research Site
Matosinhos Municipality, 4464-513
Research Site
Porto, 4099-001

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Switzerland6 sites

Research Site
Basel, 4031
Research Site
Geneva, 1211
Research Site
Lugano, 6900
Research Site
Winterthur, 8401
Research Site
Zurich, 8063
Research Site
Zurich, 8091

Other trials in Switzerland

Belgium5 sites

Research Site
Aalst, 9300
Research Site
Genk, 3600
Research Site
Ghent, 9000
Research Site
La Louvière, 7100
Research Site
Leuven, 3000

Other trials in Belgium

Sweden4 sites

Research Site
Gothenburg, 413 45
Research Site
Malmö, 205 02
Research Site
Stockholm, 141 86
Research Site
Uppsala, 751 85

Other trials in Sweden

About this study

Official title: 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.

Conditions: Hypercholesterolaemia
Keywords: hypercholesterolaemia, lipid-lowering therapies
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02770131
Study group	Role	What they receive
Group 1		To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 201630 Jun 2021

First posted12 May 2016 (estimated)
Study start4 May 2016
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 1,986 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02770131
Sponsor's protocol ID: 20130296
Acronym: HEYMANS
Status last verified: Jun 2024
First submitted: 27 Apr 2016
Last updated: 6 Jun 2024
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

Ray KK, Dhalwani N, Sibartie M, Bridges I, Ebenbichler C, Perrone-Filardi P, Villa G, Vogt A, Bruckert E. Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study. Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):447-460. doi: 10.1093/ehjqcco/qcac009.
PubMed 35175350
Blaha V, Margoczy R, Petrov I, Postadzhiyan A, Raslova K, Rosolova H, Bridges I, Dhalwani NN, Zachlederova M, Ray KK. Evolocumab is Initiated in Central and Eastern Europe at Much Higher LDL-C Levels Than Recommended in Guidelines: Results from the Observational HEYMANS Study. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231172847. doi: 10.1177/10742484231172847.
PubMed 37218974
Blanco Echevarria A, Garcia Diaz JD, Caixas A, Plana Gil N, Rico Corral MA, Bridges I, Dhalwani N, Gatell Menchen S, Ray KK. Long-term treatment persistence and maintained reduction of LDL-cholesterol levels with evolocumab over 30 months: Results from the Spanish cohort of the European prospective HEYMANS study. Clin Investig Arterioscler. 2023 Nov-Dec;35(6):263-271. doi: 10.1016/j.arteri.2023.04.004. Epub 2023 May 24. English, Spanish.
PubMed 37236829
Ebenbichler C, Drexel H, Hanusch U, Toplak H, Dhalwani NN, Bridges I, Hoelzl R, Hemetsberger M, Ray KK. Evolocumab effectiveness in the real-world setting: Austrian data from the pan-European observational HEYMANS study. Wien Klin Wochenschr. 2024 Feb;136(3-4):77-86. doi: 10.1007/s00508-023-02245-w. Epub 2023 Jul 31.
PubMed 37525072
Sudano I, Krahenbuhl S, Mach F, Anstett A, Dhalwani N, Bridges I, Sibartie M, Ray KK. Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study. Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447231213288. doi: 10.1177/17539447231213288.
PubMed 38183273
Lehrke M, Vogt A, Schettler V, Girndt M, Fraass U, Tabbert-Zitzler A, Bridges I, Dhalwani NN, Ray KK. Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study. Adv Ther. 2024 Mar;41(3):1184-1200. doi: 10.1007/s12325-023-02757-x. Epub 2024 Jan 30.
PubMed 38286961
Vlachopoulos C, Massia D, Kochiadakis G, Kolovou G, Patsilinakos S, Bridges I, Sibartie M, Dhalwani NN, Liberopoulos E, Ray KK. Evolocumab use in Greece is associated with early and sustainable reductions in low-density cholesterol (LDL-C) and high persistence to therapy: Results from the Greek cohort analysis of the observational HEYMANS study. Hellenic J Cardiol. 2023 Nov-Dec;74:74-76. doi: 10.1016/j.hjc.2023.09.003. Epub 2023 Sep 18. No abstract available.
PubMed 37730147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia
ClinicalTrials.gov ID: NCT02770131
Acronym / sponsor ID: HEYMANS / 20130296
Conditions: Hypercholesterolaemia
Keywords: hypercholesterolaemia, lipid-lowering therapies
Study type: Observational
Recruitment status: Completed
Enrolment: 1,986 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 4 May 2016 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 12 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Group 1	–	–To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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®

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

7 secondary outcomes

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®
Describe Repatha® dose over time
Time frame: 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 Physician visits
Time frame: 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
Describe Repatha® dose frequency over time
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
Background: PubMed 35175350Ray KK, Dhalwani N, Sibartie M, Bridges I, Ebenbichler C, Perrone-Filardi P, Villa G, Vogt A, Bruckert E. Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study. Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):447-460. doi: 10.1093/ehjqcco/qcac009.
Background: PubMed 37218974Blaha V, Margoczy R, Petrov I, Postadzhiyan A, Raslova K, Rosolova H, Bridges I, Dhalwani NN, Zachlederova M, Ray KK. Evolocumab is Initiated in Central and Eastern Europe at Much Higher LDL-C Levels Than Recommended in Guidelines: Results from the Observational HEYMANS Study. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231172847. doi: 10.1177/10742484231172847.
Background: PubMed 37236829Blanco Echevarria A, Garcia Diaz JD, Caixas A, Plana Gil N, Rico Corral MA, Bridges I, Dhalwani N, Gatell Menchen S, Ray KK. Long-term treatment persistence and maintained reduction of LDL-cholesterol levels with evolocumab over 30 months: Results from the Spanish cohort of the European prospective HEYMANS study. Clin Investig Arterioscler. 2023 Nov-Dec;35(6):263-271. doi: 10.1016/j.arteri.2023.04.004. Epub 2023 May 24. English, Spanish.
Background: PubMed 37525072Ebenbichler C, Drexel H, Hanusch U, Toplak H, Dhalwani NN, Bridges I, Hoelzl R, Hemetsberger M, Ray KK. Evolocumab effectiveness in the real-world setting: Austrian data from the pan-European observational HEYMANS study. Wien Klin Wochenschr. 2024 Feb;136(3-4):77-86. doi: 10.1007/s00508-023-02245-w. Epub 2023 Jul 31.
Background: PubMed 38183273Sudano I, Krahenbuhl S, Mach F, Anstett A, Dhalwani N, Bridges I, Sibartie M, Ray KK. Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study. Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447231213288. doi: 10.1177/17539447231213288.
Background: PubMed 38286961Lehrke M, Vogt A, Schettler V, Girndt M, Fraass U, Tabbert-Zitzler A, Bridges I, Dhalwani NN, Ray KK. Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study. Adv Ther. 2024 Mar;41(3):1184-1200. doi: 10.1007/s12325-023-02757-x. Epub 2024 Jan 30.
Background: PubMed 37730147Vlachopoulos C, Massia D, Kochiadakis G, Kolovou G, Patsilinakos S, Bridges I, Sibartie M, Dhalwani NN, Liberopoulos E, Ray KK. Evolocumab use in Greece is associated with early and sustainable reductions in low-density cholesterol (LDL-C) and high persistence to therapy: Results from the Greek cohort analysis of the observational HEYMANS study. Hellenic J Cardiol. 2023 Nov-Dec;74:74-76. doi: 10.1016/j.hjc.2023.09.003. Epub 2023 Sep 18. No abstract available.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Related trials for Hypercholesterolaemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

183 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolaemia, run by Amgen at 183 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in Germany, Italy, Slovakia, Greece, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of clinical characteristics of subjects initiated on Repatha® (time frame: Study day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02770131, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.