AzTrials
AzTrials

HypercholesterolemiaMILOSNCT04579367

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia

An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 443 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia, Mixed Dyslipidemia
What is being tested?
Bempedoic acid and/or its fixed-dose combination with ezetimibe
How many people
5,000 participants
Where
443 sitesin 8 countries
Study dates
15 Jan 2021to 30 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include participants with primary hypercholesterolemia or mixed dyslipidemia who are being treated with bempedoic acid and/or its fixed dose combination with ezetimibe.

Who may be able to join

  • Written informed consent to participate
  • At least 18 years of age
  • Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia treated or intended to be treated with bempedoic acid and/or its fixed dose combination with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
  • No contraindications exist according to the SmPC of bempedoic acid and/or its fixed-dose combination with ezetimibe
  • No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
  • Life expectancy > 1 year

Who cannot join

  • As this is a non-interventional study, no explicit exclusion criteria are defined. The prescribing behavior will not be influenced. Only patients will be included where the decision has been made by the treating physician to treat the patients either with bempedoic acid and/or its fixed-dose combination with ezetimibe.

Trial locations and contacts

443 sites in 8 countries.

443 sites in 8 countries

Germany147 sites

  • Downtown Clinic Aachen

    Aachen, 52062

  • Praxis Delonge

    Aachen, 52078

  • Praxis Osterziel

    Amberg, 92224

  • MVZ Helios Aue

    Aue, 08280

  • Kardiologische Praxis Enders

    Bad Elster, 08645

  • SLK-Klinikum am Plattenwald

    Bad Friedrichshall, 74177

  • Herzcarre Praxis

    Bad Homburg, 61348

  • Kardiologische Praxis

    Bad Homburg, 61348

  • Zentrum für klinische Forschung

    Bad Homburg, 61348

  • Universitätsklinikum Freiburg - Universitäts-Herzzentrum

    Bad Krozingen, 79189

  • Praxis am Landratspark

    Bad Segeberg, 23795

  • Hausärzte am Spritzenhaus

    Baiersbronn, 72270

  • CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel

    Bamberg, 96049

  • Kardiologische Praxis

    Bechhofen, 66894

  • Praxis Rankestraße

    Berlin, 10789

  • SKP Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbH

    Berlin, 10789

  • Herzpraxis Berlin MVZ

    Berlin, 12165

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

  • Dres. Seeger & Partner

    Berlin, 12627

  • Diabetespraxis Dr. Braun

    Berlin, 13187

  • Lipidambulanz Charite

    Berlin, 13353

  • Praxiszentrum Biedenkopf

    Biedenkopf, 35216

  • Praxis Dr. A. Biedermann

    Blankenhain, 99444

  • Kardiologische Gemeinschaftspraxis Bremerhaven

    Bremerhaven, 27574

  • Kardiologie im Friedrichspalast Bruchsal

    Bruchsal, 76646

  • Studiengesellschaft Könemann und Steinmann GbR

    Bünde, 32257

  • MediClin Reha-Zentrum Spreewald

    Burg, 03096

  • MVZ am Küchwald

    Chemnitz, 09113

  • Kardiologische Praxis Stellmach

    Chemnitz, 09126

  • MVZ Polymed

    Chemnitz, 09130

  • Uniklinik Köln

    Cologne, 50937

  • Zentrum für klinische Forschung

    Cologne, 51069

  • IKAPP

    Cologne, 51105

  • Praxis Dr. Menzel

    Dessau, 06846

  • Klinikum Lippe GmbH

    Detmold, 32756

  • Kardiologische Gemeinschaftspraxis

    Dortmund, 44137

  • Cardiologicum Dresden/Pirna

    Dresden, 01277

  • Hausärztliche Gemeinschaftspraxis mit diabetologischem Schwerpunkt

    Dresden, 01279

  • Dres. Günther/Kolschmann

    Dresden, 01307

  • Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

    Dresden, 01307

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • DZDM Diabeteszentrum Duisburg Mitte

    Duisburg, 47051

  • Nierenzentrum Düren

    Düren, 52351

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Praxis Dilltal

    Ehringshausen, 35630

  • Praxis Dipl. -Med. Petra Herrmann

    Eisenach, 99817

  • Kardiologische Praxis

    Elsterwerda, 04910

  • Gemeinschaftspraxis ISP Erlangen

    Erlangen, 91052

  • Hausarztzentrum am Germaniaplatz

    Essen, 45355

  • DIAKO Flensburg

    Flensburg, 24939

  • Praxis für Nieren und Hochdruck-Krankheiten

    Flensburg, 24941

  • MVZ Altstadt-Carree Fulda

    Fulda, 36037

  • Klinikum Fulda

    Fulda, 63043

  • Praxis Dr. Langel

    Gera, 07551

  • Cardiocampus Gemeinschaftspraxis für Herz- und Kreislauferkrankungen

    Gifhorn, 38518

  • Praxis für Gefäßmedizin

    Görlitz, 02827

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Praxis Dr. Müller

    Gräfenhainichen, 06773

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Evangelisches Krankenhaus Hagen-Haspe

    Hagen, 58135

  • Praxis

    Hainburg, 63512

  • Cardiologicum Hamburg - Praxis Wandsbek

    Hamburg, 22041

  • Diabetes Zentrum Wandsbeck

    Hamburg, 22041

  • MVZ Prof. Mathey, Prof. Schofer

    Hamburg, 22527

  • Kardiologie am Tibarg

    Hamburg, 22549

  • Kardiologie List

    Hanover, 30177

  • Kardiologische Praxis

    Hanover, 30559

  • Kardiologische Praxis

    Haßloch, 67454

  • Kardiologische Schwerpunktpraxis

    Heidelberg, 69115

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Praxis Heik/Wedig

    Heiligenstadt, 37308

  • KARDIO-IN Kardiologische Gemeinschaftspraxis

    Ingolstadt, 85049

  • Kardiologische Praxis

    Kaiserslautern, 67655

  • SRH Klinikum Karlsbad-Langensteinbach

    Karlsbad, 76307

  • B. Braun Ambulantes Herzzentrum Kassel

    Kassel, 34121

  • Praxis Dr. Heiner Müller

    Katzhütte, 98746

  • Nephrologie Kiel

    Kiel, 24106

  • Gemeinschaftsklinikum Mittelrhein

    Koblenz, 56068

  • Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz

    Konstanz, 78464

  • Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann

    Kornwestheim, 70806

  • Kardiologische Praxis Kyritz

    Kyritz, 16866

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Kardiologische Praxis Boudriot

    Leipzig, 04129

  • MVZ Stoffwechselmedizin Leipzig

    Leipzig, 04317

  • Praxis Dr. I.Simon-Wagner

    Lichtenfels, 96215

  • St. Vincenz Krankenhaus

    Limburg, 65549

  • Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet

    Löhne, 32584

  • Universität zu Lübeck

    Lübeck, 23538

  • Cardio Centrum Ludwigsburg-Bietigheim

    Ludwigsburg, 71634

  • Kardiologische Praxisklinik Ludwigshafen

    Ludwigshafen, 67071

  • Institut für Präventive Medizin & Klinische Forschung GbR

    Magdeburg, 39110

  • Cardiopraxis Mainz

    Mainz, 55122

  • Katholisches Klinikum Mainz

    Mainz, 55131

  • Universitätsklinikum Mainz

    Mainz, 55131

  • ZE:RO Praxen

    Mannheim, 68165

  • UMM Mannheim

    Mannheim, 68167

  • Kardiologische Praxis

    Markkleeberg, 04416

  • Praxis Ben-Chur

    Meiningen, 98617

  • Praxis Haj-Yehia

    Moers, 47441

  • Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte

    Mühldorf, 84453

  • Kardiologie Mühldorf am Inn

    Mühldorf, 84453

  • Herzquartier Mülheim

    Mülheim, 45468

  • Kardiologie Neuhausen-Nymphenburg

    München, 80634

  • Dres. Wauer/Windstetter

    München, 80799

  • Praxis Kiepenkerl

    Münster, 48143

  • Zentrum für Kardiologie an der Raphaelsklinik Münster

    Münster, 48143

  • Praxis für Innere Medizin Münster

    Münster, 48149

  • Universitätsklinikum Münster

    Münster, 48149

  • Internistische Praxisgemeinschaft

    Neu-Isenburg, 63263

  • Kardiologische Praxis Northeim

    Northeim, 37154

  • Hausarztpraxis

    Oer-Erkenschwick, 45739

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098

  • Kardiologische Praxis Papenburg - Site 6071

    Papenburg, 26871

  • Kardiologische Praxis Papenburg - Site 6072

    Papenburg, 26871

  • Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan

    Passau, 94032

  • Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH

    Pirna, 01796

  • Kinikum Ernst von Bergmann

    Potsdam, 14467

  • VieSante Herzmedizin Potsdam

    Potsdam, 14469

  • Kardiologische Gemeinschaftspraxis

    Potsdam, 14471

  • Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann

    Radebeul, 01445

  • Internistisch hausärtzliche Gemeinschaftspraxis Dr. Hildebrandt & Dr. Mutscher

    Radebeul, 01445

  • Gemeinschaftspraxis Herz Riesa

    Riesa, 01587

  • Universitätsmedizin Rostock

    Rostock, 18057

  • Facharztpraxis für Kardiologie und Innere Medizin

    Schwäbisch Hall, 74523

  • MVZ Schwerin West GmbH

    Schwerin, 19057

  • Nierenzentrum Altmark

    Seehausen, 39615

  • Zentrum für Prävention und Rehabilitation

    Siegen, 57072

  • Klinik Singen

    Singen, 78224

  • MEDINOS Klinik Sonneberg

    Sonneberg, 96515

  • Kardiologische Praxis im Steiner Thor

    Straubing, 94315

  • Praxis Dr Knöbel u. Partner

    Straubing, 94315

  • Praxis Dr. Michael Rother

    Strausberg, 15344

  • Diabetologische Schwerpunktpraxis

    Trier, 54292

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Studienzentrum der Herzklinik Ulm GbR

    Ulm, 89077

  • Praxis Dr. Hansen

    Unterwellenborn, 07333

  • Praxis Dr. Dengler/Hohenstatt

    Ursensollen, 92289

  • Herzzentrum Saar

    Völklingen, 66333

  • GRN Weinheim

    Weinheim, 69469

  • Kardiologische Praxis Al-Zoebi

    Wermsdorf, 04779

  • Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße

    Weyhe, 28844

  • Forschungszentrum-Ruhr / KliFoCenter GmbH

    Witten, 58455

  • Kardiologische Praxis Tamm/Hoh

    Wittenberg, 06886

  • Kardiologische Fachpraxis

    Wolmirstedt, 39326

  • Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue

    Wuppertal, 42103

  • Universitätsklinikum Würzburg

    Würzburg, 97080

  • Gemeinschaftspraxis am Angerbrunnen

    Zwiesel, 94227

Other trials in Germany

Italy104 sites

  • Ospedale Generale Regionale "F. Miulli"

    Acquaviva delle Fonti, 70021

  • P.O. Agrigento Ospedale San Giovanni di Dio

    Agrigento, 92100

  • IRCCS-INRCA Ancona

    Ancona, 60127

  • Ospedale di Anzio

    Anzio, 00042

  • Ospedale dei Castelli

    Ariccia, 00072

  • Ospedale "C. e G. Mazzoni"

    Ascoli Piceno, 63100

  • A.O. San Giuseppe Moscati

    Avellino, 83100

  • Ospedale SS Nicola e Filippo

    Avezzano, 67051

  • Ospedale S. Paolo

    Bari, 70123

  • A.O.U. Consorziale - Policlinico Bari

    Bari, 70124

  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08016

    Bari, 70124

  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08017

    Bari, 70124

  • AUSL Bologna Ospedale di Bentivoglio

    Bentivoglio, 40010

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • Ospedale Maggiore Carlo Alberto Pizzardi

    Bologna, 40133

  • Policlinico Sant'Orsola Bologna-Malpighi

    Bologna, 40138

  • Ospedale di Bolzano - Site 08070

    Bolzano, 39100

  • Ospedale di Bolzano - Site 08112

    Bolzano, 39100

  • Spedali Civili di Brescia

    Brescia, 25123

  • Ospedale Santo Spirito Casale Monferrato

    Casale Monferrato, 15033

  • A.O. S. Anna e S. Sebastiano

    Caserta, 81100

  • ULLS 2 MARCA TREVIGIANA Ospedale di Castelfranco Veneto

    Castelfranco Veneto, 31033

  • AOU Policlinico Vittorio Emanuele Presidio Ospedaliero Gaspare Rodolico

    Catania, 95124

  • Azienda Ospedaliera Cannizzaro

    Catania, 95126

  • L'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro

    Catanzaro, 88100

  • Ospedale Civile Santa Maria Incoronata dell'Olmo

    Cava de' Tirreni, 84013

  • Policlinico SS. Annunziata

    Chieti, 66100

  • ASL TO4 Presidio Riunito di Ciriè-Lanzo

    Cirié, 10073

  • Azienda Ospedaliero-Universitaria di Ferrara "Arcispedale Sant'Anna"

    Cona, 44124

  • Ospedale San Salvatore

    Coppito, 67100

  • Ospedale Santa Maria Nuova

    Florence, 50122

  • AOU Careggi - Site 08067

    Florence, 50134

  • AOU Careggi - Site 08081

    Florence, 50134

  • AOU Careggi - Site 08090

    Florence, 50134

  • Azienda Ospedaliera Universitaria "Ospedali Riuniti" di Foggia

    Foggia, 71122

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Presidio Ospedaliero S.O. Padre Antero Micone

    Genova, 16153

  • Ospedale della Misericordia

    Grosseto, 58100

  • Ospedale Sant'Andrea

    La Spezia, 19121

  • ASP Catanzaro Presidio Ospedaliero "Giovanni Paolo II"

    Lamezia Terme, 88046

  • Ospedale Vito Fazzi

    Lecce, 73100

  • Ospedale Mater Salutis

    Legnago, 37045

  • Presidio Ospedaliero "Madonna delle Grazie"

    Matera, 75100

  • Presidio ospedaliero San Giovanni di Dio

    Melfi, 85025

  • A.O.U. Policlinico "G. Martino"

    Messina, 98124

  • ULSS 3 SERENISSIMA Ospedale dell'Angelo

    Mestre, 30174

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08039

    Milan, 20122

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08097

    Milan, 20122

  • Centro Cardiologico Monzino

    Milan, 20138

  • Ospedale San Luca - Gruppo Istituto Auxologico Italiano

    Milan, 20149

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Niguarda

    Milan, 20162

  • ULSS 3 Serenissima Presidio Ospedaliero di Mirano

    Mirano, 30035

  • AOU Modena Policlinico Modena

    Modena, 41125

  • A.O.R.N. Antonio Cardarelli

    Naples, 80131

  • A.O.R.N. MONALDI OSPEDALE DEI COLLI Ospedale Monaldi

    Naples, 80131

  • A.O.U. Federico Ii

    Naples, 80131

  • Azienda Ospedaliera Specialistica dei Colli Ospedale Monaldi

    Naples, 80131

  • Policlinico Università Federico II - Napoli

    Naples, 80131

  • Ospedale Umberto I

    Nocera Inferiore, 84014

  • AOU Maggiore della Carità di Novara

    Novara, 28100

  • Ospedale San Giacomo

    Novi Ligure, 15067

  • Azienda ospedaliera-Università di Padova

    Padova, 35128

  • A.O.U. Policlinico "P. Giaccone"

    Palermo, 90127

  • Casa di Cura Triolo Zancla Hospital

    Palermo, 90133

  • ICS Maugeri

    Pavia, 27100

  • USL Umbria I

    Perugia, 06126

  • Azienda Ospedaliera S. Maria della Misericordia di Perugia

    Perugia, 06129

  • Ospedale Guglielmo da Saliceto

    Piacenza, 29121

  • Fondazione Monasterio

    Pisa, 56124

  • P. O. Portogruaro

    Portogruaro, 30026

  • Azienda Ospedaliera Regionale San Carlo di Potenza

    Potenza, 85100

  • Nuovo Ospedale Santo Stefano

    Prato, 59100

  • Azienda Sanitaria Provinciale di Ragusa Ospedale Giovanni Paolo II

    Ragusa, 97100

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

  • ASST Rhodense - Ospedale di Circolo di Rho

    Rho, 20017

  • Ospedale San Camillo De Lellis

    Rieti, 02100

  • Ospedale Infermi AUSL Romagna

    Rimini, 47923

  • Ospedale degli Infermi di Rivoli

    Rivoli, 10098

  • Policlinico Tor Vergata

    Roma, 00133

  • Ospedale Sandro Pertini

    Roma, 00157

  • Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08046

    Roma, 00168

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08121

    Roma, 00168

  • Policlinico Casilino

    Roma, 00169

  • AOU S. Andrea

    Roma, 00189

  • A.O. San Giovanni di Dio e Ruggi D'Aragona

    Salerno, 84131

  • ASST Valle Olona P.O. Saronno

    Saronno, 21047

  • Ospedale S. Bartolomeo

    Sarzana, 19038

  • AOU Sassari Ospedale SS. Annunziata

    Sassari, 07100

  • IRCCS Multimedica

    Sesto San Giovanni, 20099

  • A.O.U. Senese Ospedale Santa Maria alle Scotte

    Siena, 53100

  • AOU Senese- Policlinico Le Scotte

    Siena, 53100

  • Casa di cura Villa Verde

    Taranto, 74121

  • Azienda Ospedaliera Santa Maria

    Terni, 05100

  • Ospedale Mauriziano Presidio Umberto I

    Torino, 10128

  • AOU Ospedali Riuniti di Ancona

    Torrette, 60126

  • Ospedale Santa Chiara

    Trento, 38122

  • ULLS 2 MARCA TREVIGIANA Ospedale Ca' Foncello

    Treviso, 31100

  • Ospedale di Cattinara

    Trieste, 34149

  • Ospedale Santa Maria della Misericordia

    Udine, 33100

  • Ospedale Santa Maria della Misericordia

    Urbino, 61029

  • ASST Settelaghi Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

  • Ospedale Castelli Verbania

    Verbania, 28922

Other trials in Italy

Spain66 sites

  • Hospital General de Albacete

    Albacete, 02006

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922

  • Hospital Virgen de los Lirios

    Alcoy, 03804

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

  • Hospital Universitario Torrecárdenas

    Almería, 04009

  • Hospital Universitario Central de Asturias

    Asturias, 33011

  • Clínica Mapfre Salud Gijón

    Asturias, 33202

  • Hospital Universitario San Agustin

    Asturias, 33410

  • Hospital Universitario Nuestra Señora del Perpetuo Socorro

    Badajoz, 06010

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Hospital de Bellvitge

    Barcelona, 08902

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • Hospital Universitario de Burgos

    Burgos, 09003

  • Hospital Universitario San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital General Universitario de Castellón

    Castellon, 12004

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital del Henares

    Coslada, Madrid, 28822

  • Hospital de Denia

    Denia, 03700

  • Hospital UNiversitario de Donostia

    Donostia / San Sebastian, 20014

  • Hospital de Fuenlabrada

    Fuenlabrada Madrid, 28942

  • Hospital Universitario de Cabueñes

    Gijón, 33394

  • Hospital Universitario Virgen de las Nieves

    Granada, 18013

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21110

  • Hospital Universitario Médico-Quirúrgico de Jaén

    Jaén, 23007

  • Hospital Jerez de la Frontera

    Jerez de La Frontera, Cádiz, 11407

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, 35010

  • Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario de León

    León, 24008

  • Hospital San Pedro

    Logroño, 26006

  • Hospital UNiversitario la Princesa

    Madrid, 28006

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital HM Montepríncipe

    Madrid, 28660

  • Hospital Universitario de Torrejón

    Madrid, 28850

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda Madrid, 28222

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majdahonda Madrid, 28222

  • Consulta de Cardiología Dr. Javier Mora Robles

    Málaga, 29002

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Costa del Sol

    Marbella Málaga, 29603

  • Hospital de Mendaro

    Mendaro, 20850

  • Hospital General Universitario Reina Sofía

    Murcia, 30003

  • Hospital Clínico Universitario Virgen Arrixaca

    Murcia, 30120

  • Hospital Universitario Son LLatzer

    Palma de Mallorca, 07193

  • Hospital Universitario de Navarra

    Pamplona, 31008

  • Hospital de Sagunto

    Port de Sagunt, 46520

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital de Valme

    Seville, 41014

  • Hospital Universitario Vírgen del Rocío

    Seville, 411013

  • Hospital General Universitario de Toledo

    Toledo, 45007

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Arnau de Vilanova

    Valencia, 46015

  • Vithas Valencia 9 de Octubre

    Valencia, 46015

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46016

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Hospital Universitario Rio Hortega

    Valladolid, 47130

  • Hospital de La Plana

    Villarreal, Castellón, 12540

  • Hospital Clinico Universitaro Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Belgium36 sites

  • ASZ

    Aalst, 9300

  • Clinique Saint-Luc Bouge Namur

    Bouge, B-5005

  • Epicura Hornu

    Boussu, B-7301

  • A.Z. KLINA Brasschaat

    Brasschaat, B-2930

  • Clinique Saint-Jean Bruxelles

    Brussels, B-1000

  • CHU Brugman

    Brussels, B-1020

  • CUB-Hôpital Erasme

    Brussels, B-1070

  • UZ Brussel

    Brussels, B-1090

  • Clinique de l'Europe Saint Elisabeth

    Brussels, B-1180

  • UCL Saint-Luc Woluwé Bruxelles

    Brussels, B-1200

  • Private Practice

    Ciney, B-5590

  • Az Sint Blazius

    Dendermonde, 9200

  • UZ Antwerpen

    Edegem, B-2650

  • Z.O.L - Campus St. Jan

    Genk, B-3600

  • AZ St-Lucas & Volkskliniek

    Ghent, B-9000

  • UZ Gent

    Ghent, B-9000

  • GHDC Charleroi - Site Hôpital Saint-Joseph

    Gilly, B-6060

  • Private Practice

    Gribomont, B-6887

  • Pôle hospitalier Jolimont

    Haine-Saint-Paul, B-7100

  • BVBA Med Kab

    Halen, B-3545

  • Jessa Ziekenhuis

    Hasselt, B-3500

  • CHR Huy

    Huy, B-4500

  • JAN YPERMAN Ziekenhuis

    Ieper, B-9800

  • AZ Groeninge Kortrijk

    Kortrijk, B-8500

  • CHU Tivoli

    La Louvière, B-7100

  • UZ Leuven

    Leuven, B-3000

  • CHR Citadelle de Liège

    Liège, B-4000

  • CHU Liège

    Liège, B-4000

  • CHU Charleroi Hopital civil Marie-Curie

    Lodelinsart, B-6042

  • CHU Mons Ambroise Paré

    Mons, B-7000

  • AZ Sint Jan

    Ostend, B-8400

  • AZ Delta

    Roeselare, B-8800

  • AZ Glorieux

    Ronse, B-9600

  • Sint Trudo

    Sint-Truiden, B-3800

  • Sint-Andriesziekenhuis Tielt

    Tielt, B-8700

  • CHU UCL Mont-Godinne

    Yvoir, B-5530

Other trials in Belgium

United Kingdom32 sites

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG

  • South Eastern Ulster Hospital

    Belfast, BT16 1RH

  • University Hospital of Wales

    Cardiff, CF64 2XX

  • Rowden Surgery

    Chippenham, SN15 2SB

  • Craigavon Area Hospital

    Craigavon, BT63 5QQ

  • Darlington Memorial Hospital

    Darlington, DL3 6HX

  • University Hospital North Durham

    Durham, DH1 5TW

  • Oaks Healthcare

    Hampshire, PO8 8DL

  • West Morland General Hospital

    Kendal, LA9 7RG

  • North Blaby PCN

    Leicester, LE19 4LY

  • Barts Health NHS Trust/ QMUL

    London, EC1M 6BQ

  • Freuchen Medical Centre

    London, NW10 4ST

  • Royal Free Hospital Lipid Clinic

    London, NW3 2QG

  • Hammersmith Hospital

    London, W12 0HS

  • Imperial College London

    London, W6 8RP

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • STRIVE, The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • North Tees Hospital

    Northumbria, TS19 8PE

  • City Hospital

    Nottingham, NG5 1PB

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

  • Whiston Hospital

    Prescot, L35 5DR

  • North Manchester General Hospital

    Salford, M6 8HD

  • Queen's Hospital Lipid Clinic

    Staffordshire, DE13 0RB

  • Princess Royal Hospital

    Telford, TF1 6TF

  • Torbay and South Devon NHS Foundation Trust

    Torquay, TQ2 7AA

  • Trowbridge Health Centre

    Trowbridge, BA14 8LW

  • North Wales Cardiac Centre

    Wales, LL57 2PW

  • Wansford and Kings Cliffe Practice

    Wansford, PE8 6PL

  • Bridgewater Surgeries

    Watford, WD18 7QR

Other trials in United Kingdom

Netherlands21 sites

  • ZGT

    Almelo, 7609 PP

  • Meander Mc

    Amersfoort, 3813 TZ

  • AUMC

    Amsterdam, 1105 AZ

  • Mc Leeuwarden

    Amsterdam, 8934 AD

  • Rijnstate

    Arnhem, 6815 AD

  • AMPHIA

    Breda, 4818 CK

  • Albert Schweitzer

    Dordrecht, 3318 AT

  • ZGV

    Ede, 6716 RP

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM

  • GHZ

    Gouda, 2803 HH

  • Spaarne Gasthuis

    Haarlem, 2035 RC

  • Saxenburgh Medisch Centrum

    Hardenberg, 7772 SE

  • Tergooi Mc

    Hilversum, 1212 VG

  • Treant Bethesda Hoogeveen

    Hoogeveen, 7900 RA

  • Dijklander

    Hoorn, 1624 NP

  • ALRIJNE

    Leiderdorp, 2353 GA

  • MUMC+

    Maastricht, 6229 HX

  • Erasmus Mc

    Rotterdam, 3015 GD

  • Franciscus Gasthuis

    Rotterdam, 3045 PM

  • MAASSTAD

    Rotterdam, 3079 DZ

  • Isala Zwolle

    Zwolle, 8025 AB

Other trials in Netherlands

Austria20 sites

  • Dr. Armin Öhlinger Kardiologe & innere Medizin

    Dornbirn, 6850

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6807

  • LKH-Univ. Klinikum Graz

    Graz, 8036

  • Medizinische Universität Graz

    Graz, 8036

  • Internist Dr. med. univ. Stefan Moser

    Hörsching, 4063

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • KABEG Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

  • Konventhospital der Barmherzigen Brüder Linz

    Linz, 4020

  • Ordination Dr. Johannes Föchterle

    Linz, 4040

  • Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl

    Mattersburg, 7210

  • Kompetenz-Zentrum Diabetes

    Salzburg, 5026

  • Ordination Universitätsdozent Dr. Alexander Kober

    Sankt Aegyd am Neuwalde, 3193

  • Ordination Dr. med. univ. Evelyn Fließer-Görzer

    Sankt Stefan ob Stainz, 8511

  • Ordination Dr. Thomas Maca

    Vienna, 1010

  • Klinik Hietzing, Wiener Gesundheitsverbund

    Vienna, 1030

  • Zentrum für Klinische Studien Dr. Hanusch GmbH

    Vienna, 1060

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090

  • Univ.-Prof. Dr. Thomas Stulnig

    Vienna, 1130

  • Herz Zentrum Währing

    Vienna, 1180

  • Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung

    Vienna, 1210

Other trials in Austria

Switzerland17 sites

  • Diabetologie & Endokrinologie Baden

    Baden, 5400

  • University Hospital Basel

    Basel, 4031

  • Inselspital, Universitätsspital Bern

    Bern, 3010

  • Praxis Dr. med Urs Beat Gröflin

    Binningen, 4102

  • Hochgebirgsklinik Davos

    Davos, 7265

  • Spital Lachen AG

    Lachen, 8853

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011

  • University of Lausanne

    Lausanne, 1011

  • Kantonsspital Baselland

    Liestal, 4410

  • EOC Ente Ospedaliero Cantonale

    Lugano, 6900

  • MIP Associazione Medico in Pratica c/o Studio Medico Cardiologico Acquistapace

    Lugano, 6900

  • Praxis Prof. Dr. med. Gottfried Rudofsky

    Olten, 4600

  • HÔPITAL RIVIERA-CHABLAIS, VAUD-VALAIS, Centre hospitalier de Rennaz

    Rennaz, 1847

  • Kantonsspital St.Gallen

    Sankt Gallen, CH-9007

  • Spital Thun

    Thun, 3600

  • Prof. Dr. med. Stephane Bosquet

    Yverdon-les-Bains, 1400

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Non-interventional Study on the Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS)

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C).

Secondary objectives are to document and evaluate as applicable:

  • Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. Systematic Coronary Risk Estimation (SCORE) system, SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only).
  • Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp[a]) compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe.
  • Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable.
  • Relevant CV events:
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft surgery (CABG)
  • Percutaneous transluminal coronary angioplasty (PTCA)
  • Stroke
  • Transient ischemic attack (TIA)
  • Acute peripheral arterial occlusion
  • All-cause death
  • Cardiovascular (CV)-death
  • Adverse effects associated with lipid-modifying treatment (LMT)
  • Laboratory abnormalities
  • Muscle-associated symptoms
  • New onset and/or worsening diabetes
  • Changes in the patients´ glycemic status over time
  • Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe.
  • Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments).
  • Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions).
  • Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.
Read the detailed description

This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.

Being tested
Bempedoic acid and/or its fixed-dose combination with ezetimibe
Keywords
Hypercholesterolemia, Mixed dyslipidemia, Bempedoic acid and/or its fixed-dose combination with ezetimibe
Medical subject headings
Hypercholesterolemia

What participants receive

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

  • Bempedoic acid and/or its fixed-dose combination with ezetimibeDrug

    This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.

Study groups in NCT04579367
Study groupRoleWhat they receive
Bempedoic acid and/or fixed-dose combination with ezetimibeParticipants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.
Receives: Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe

What is being measured

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

  1. Summary of patient characteristics in patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe

    Measured: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

Secondary outcomes (4)

  1. Overview of the cardiovascular risk of patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid/ and/or its fixed-dose combination with ezetimibe

    Cardiovascular risk scores will be assessed using the Systematic Coronary Risk Estimation (SCORE) system, Second manifestations of arterial disease (SMART) and Framingham risk scores. The SMART risk score will estimate 10-year risk for very high-risk participants based on clinical patient characteristics. The gender-specific Framingham risk score will be used to estimate 10-year cardiovascular risk for high-risk participants.

    Measured: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

  2. Summary of changes in plasma low-density lipoprotein cholesterol levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia

    Measured: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

  3. Summary in changes in plasma levels of atherosclerotic cardiovascular disease-modifying cholesterol fragments following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe

    Plasma levels of total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs) and lipoprotein a (Lp[a]) will be assessed.

    Measured: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

  4. Summary of changes in plasma inflammatory marker hsCRP levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia

    Inflammatory status was assessed using high-sensitive C-reactive protein.

    Measured: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)

Timeline

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

  1. First posted8 Oct 2020
  2. Study start15 Jan 2021
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579367
Sponsor's protocol ID
DSE-BMP-01-20-EU
Acronym
MILOS
Status last verified
Sep 2026
First submitted
1 Oct 2020
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 443 sites in 8 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 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 443 sites in Germany, Italy, Spain, Belgium, United Kingdom and 3 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?

This study is still under way. Results are not available in the source record yet.

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?

Summary of patient characteristics in patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe (time frame: Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)). 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 NCT04579367.

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 30 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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