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

March 17, 2026 updated by: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe

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.

Study Type

Observational

Enrollment (Estimated)

5000

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
- - Dornbirn, Austria, 6850
    - Dr. Armin Öhlinger Kardiologe & innere Medizin
  - Feldkirch, Austria, 6807
    - Landeskrankenhaus Feldkirch
  - Graz, Austria, 8036
    - Lkh-Univ. Klinikum Graz
  - Graz, Austria, 8036
    - Medizinische Universität Graz
  - Hörsching, Austria, 4063
    - Internist Dr. med. univ. Stefan Moser
  - Innsbruck, Austria, 6020
    - Medizinische Universität Innsbruck
  - Klagenfurt, Austria, 9020
    - KABEG Klinikum Klagenfurt am Wörthersee
  - Linz, Austria, 4020
    - Konventhospital der Barmherzigen Brüder Linz
  - Linz, Austria, 4040
    - Ordination Dr. Johannes Föchterle
  - Mattersburg, Austria, 7210
    - Ordination Frau Prof. Dr. Yvonne Winhofer-Stöckl
  - Salzburg, Austria, 5026
    - Kompetenz-Zentrum Diabetes
  - Sankt Aegyd am Neuwalde, Austria, 3193
    - Ordination Universitätsdozent Dr. Alexander Kober
  - Sankt Stefan ob Stainz, Austria, 8511
    - Ordination Dr. med. univ. Evelyn Fließer-Görzer
  - Vienna, Austria, 1210
    - Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung
  - Vienna, Austria, 1090
    - Allgemeines Krankenhaus der Stadt Wien
  - Vienna, Austria, 1180
    - Herz Zentrum Währing
  - Vienna, Austria, 1010
    - Ordination Dr. Thomas Maca
  - Vienna, Austria, 1030
    - Klinik Hietzing, Wiener Gesundheitsverbund
  - Vienna, Austria, 1060
    - Zentrum für Klinische Studien Dr. Hanusch GmbH
  - Vienna, Austria, 1130
    - Univ.-Prof. Dr. Thomas Stulnig
Belgium
- - Aalst, Belgium, 9300
    - ASZ
  - Bouge, Belgium, B-5005
    - Clinique Saint-Luc Bouge Namur
  - Boussu, Belgium, B-7301
    - Epicura Hornu
  - Brasschaat, Belgium, B-2930
    - A.Z. KLINA Brasschaat
  - Brussels, Belgium, B-1090
    - UZ Brussel
  - Brussels, Belgium, B-1000
    - Clinique Saint-Jean Bruxelles
  - Brussels, Belgium, B-1020
    - CHU Brugman
  - Brussels, Belgium, B-1070
    - CUB-Hôpital Erasme
  - Brussels, Belgium, B-1180
    - Clinique de l'Europe Saint Elisabeth
  - Brussels, Belgium, B-1200
    - UCL Saint-Luc Woluwé Bruxelles
  - Ciney, Belgium, B-5590
    - Private Practice
  - Dendermonde, Belgium, 9200
    - Az Sint Blazius
  - Edegem, Belgium, B-2650
    - UZ Antwerpen
  - Genk, Belgium, B-3600
    - Z.O.L - Campus St. Jan
  - Ghent, Belgium, B-9000
    - UZ Gent
  - Ghent, Belgium, B-9000
    - AZ St-Lucas & Volkskliniek
  - Gilly, Belgium, B-6060
    - GHDC Charleroi - Site Hôpital Saint-Joseph
  - Gribomont, Belgium, B-6887
    - Private Practice
  - Haine-Saint-Paul, Belgium, B-7100
    - Pôle Hospitalier Jolimont
  - Halen, Belgium, B-3545
    - BVBA Med Kab
  - Hasselt, Belgium, B-3500
    - Jessa Ziekenhuis
  - Huy, Belgium, B-4500
    - CHR Huy
  - Ieper, Belgium, B-9800
    - Jan Yperman Ziekenhuis
  - Kortrijk, Belgium, B-8500
    - AZ Groeninge Kortrijk
  - La Louvière, Belgium, B-7100
    - CHU Tivoli
  - Leuven, Belgium, B-3000
    - UZ Leuven
  - Liège, Belgium, B-4000
    - Chu Liege
  - Liège, Belgium, B-4000
    - CHR Citadelle de Liège
  - Lodelinsart, Belgium, B-6042
    - CHU Charleroi Hopital civil Marie-Curie
  - Mons, Belgium, B-7000
    - CHU Mons Ambroise Paré
  - Ostend, Belgium, B-8400
    - AZ Sint Jan
  - Roeselare, Belgium, B-8800
    - AZ Delta
  - Ronse, Belgium, B-9600
    - AZ Glorieux
  - Sint-Truiden, Belgium, B-3800
    - Sint Trudo
  - Tielt, Belgium, B-8700
    - Sint-Andriesziekenhuis Tielt
  - Yvoir, Belgium, B-5530
    - CHU UCL Mont-Godinne
Germany
- - Aachen, Germany, 52062
    - Downtown Clinic Aachen
  - Aachen, Germany, 52078
    - Praxis Delonge
  - Amberg, Germany, 92224
    - Praxis Osterziel
  - Aue, Germany, 08280
    - MVZ Helios Aue
  - Bad Elster, Germany, 08645
    - Kardiologische Praxis Enders
  - Bad Friedrichshall, Germany, 74177
    - SLK-Klinikum am Plattenwald
  - Bad Homburg, Germany, 61348
    - Kardiologische Praxis
  - Bad Homburg, Germany, 61348
    - Herzcarre Praxis
  - Bad Homburg, Germany, 61348
    - Zentrum für klinische Forschung
  - Bad Krozingen, Germany, 79189
    - Universitätsklinikum Freiburg - Universitäts-Herzzentrum
  - Bad Segeberg, Germany, 23795
    - Praxis am Landratspark
  - Baiersbronn, Germany, 72270
    - Hausärzte am Spritzenhaus
  - Bamberg, Germany, 96049
    - CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel
  - Bechhofen, Germany, 66894
    - Kardiologische Praxis
  - Berlin, Germany, 12203
    - Charite - Universitatsmedizin Berlin
  - Berlin, Germany, 10789
    - Praxis Rankestrasse
  - Berlin, Germany, 12165
    - Herzpraxis Berlin MVZ
  - Berlin, Germany, 12627
    - Dres. Seeger & Partner
  - Berlin, Germany, 13187
    - Diabetespraxis Dr. Braun
  - Berlin, Germany, 13353
    - Lipidambulanz Charite
  - Berlin, Germany, 10789
    - SKP Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbH
  - Biedenkopf, Germany, 35216
    - Praxiszentrum Biedenkopf
  - Blankenhain, Germany, 99444
    - Praxis Dr. A. Biedermann
  - Bremerhaven, Germany, 27574
    - Kardiologische Gemeinschaftspraxis Bremerhaven
  - Bruchsal, Germany, 76646
    - Kardiologie im Friedrichspalast Bruchsal
  - Burg, Germany, 03096
    - MEDICLIN Reha-Zentrum Spreewald
  - Bünde, Germany, 32257
    - Studiengesellschaft Könemann und Steinmann GbR
  - Chemnitz, Germany, 09113
    - MVZ am Küchwald
  - Chemnitz, Germany, 09130
    - MVZ Polymed
  - Chemnitz, Germany, 09126
    - Kardiologische Praxis Stellmach
  - Cologne, Germany, 50937
    - Uniklinik Köln
  - Cologne, Germany, 51069
    - Zentrum für klinische Forschung
  - Cologne, Germany, 51105
    - IKAPP
  - Dessau, Germany, 06846
    - Praxis Dr. Menzel
  - Detmold, Germany, 32756
    - Klinikum Lippe GmbH
  - Dortmund, Germany, 44137
    - Kardiologische Gemeinschaftspraxis
  - Dresden, Germany, 01307
    - Universitatsklinikum Carl Gustav Carus
  - Dresden, Germany, 01307
    - Dres. Günther/Kolschmann
  - Dresden, Germany, 01307
    - Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
  - Dresden, Germany, 01277
    - Cardiologicum Dresden/Pirna
  - Dresden, Germany, 01279
    - Hausärztliche Gemeinschaftspraxis mit diabetologischem Schwerpunkt
  - Duisburg, Germany, 47051
    - DZDM Diabeteszentrum Duisburg Mitte
  - Düren, Germany, 52351
    - Nierenzentrum Düren
  - Düsseldorf, Germany, 40225
    - Universitatsklinikum Dusseldorf
  - Ehringshausen, Germany, 35630
    - Praxis Dilltal
  - Eisenach, Germany, 99817
    - Praxis Dipl. -Med. Petra Herrmann
  - Elsterwerda, Germany, 04910
    - Kardiologische Praxis
  - Erlangen, Germany, 91052
    - Gemeinschaftspraxis ISP Erlangen
  - Essen, Germany, 45355
    - Hausarztzentrum am Germaniaplatz
  - Flensburg, Germany, 24939
    - DIAKO Flensburg
  - Flensburg, Germany, 24941
    - Praxis für Nieren und Hochdruck-Krankheiten
  - Fulda, Germany, 36037
    - MVZ Altstadt-Carree Fulda
  - Fulda, Germany, 63043
    - Klinikum Fulda
  - Gera, Germany, 07551
    - Praxis Dr. Langel
  - Gifhorn, Germany, 38518
    - Cardiocampus Gemeinschaftspraxis für Herz- und Kreislauferkrankungen
  - Greifswald, Germany, 17475
    - Universitätsmedizin Greifswald
  - Gräfenhainichen, Germany, 06773
    - Praxis Dr. Müller
  - Görlitz, Germany, 02827
    - Praxis für Gefäßmedizin
  - Göttingen, Germany, 37075
    - Universitätsmedizin Göttingen
  - Hagen, Germany, 58135
    - Evangelisches Krankenhaus Hagen-Haspe
  - Hainburg, Germany, 63512
    - Praxis
  - Hamburg, Germany, 22041
    - Cardiologicum Hamburg - Praxis Wandsbek
  - Hamburg, Germany, 22041
    - Diabetes Zentrum Wandsbeck
  - Hamburg, Germany, 22527
    - MVZ Prof. Mathey, Prof. Schofer
  - Hamburg, Germany, 22549
    - Kardiologie am Tibarg
  - Hanover, Germany, 30559
    - Kardiologische Praxis
  - Hanover, Germany, 30177
    - Kardiologie List
  - Haßloch, Germany, 67454
    - Kardiologische Praxis
  - Heidelberg, Germany, 69120
    - Universitatsklinikum Heidelberg
  - Heidelberg, Germany, 69115
    - Kardiologische Schwerpunktpraxis
  - Heiligenstadt, Germany, 37308
    - Praxis Heik/Wedig
  - Ingolstadt, Germany, 85049
    - KARDIO-IN Kardiologische Gemeinschaftspraxis
  - Kaiserslautern, Germany, 67655
    - Kardiologische Praxis
  - Karlsbad, Germany, 76307
    - SRH Klinikum Karlsbad-Langensteinbach
  - Kassel, Germany, 34121
    - B. Braun Ambulantes Herzzentrum Kassel
  - Katzhütte, Germany, 98746
    - Praxis Dr. Heiner Müller
  - Kiel, Germany, 24106
    - Nephrologie Kiel
  - Koblenz, Germany, 56068
    - Gemeinschaftsklinikum Mittelrhein
  - Konstanz, Germany, 78464
    - Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz
  - Kornwestheim, Germany, 70806
    - Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann
  - Kyritz, Germany, 16866
    - Kardiologische Praxis Kyritz
  - Leipzig, Germany, 04103
    - Universitatsklinikum Leipzig
  - Leipzig, Germany, 04317
    - MVZ Stoffwechselmedizin Leipzig
  - Leipzig, Germany, 04129
    - Kardiologische Praxis Boudriot
  - Lichtenfels, Germany, 96215
    - Praxis Dr. I.Simon-Wagner
  - Limburg, Germany, 65549
    - St. Vincenz Krankenhaus
  - Ludwigsburg, Germany, 71634
    - Cardio Centrum Ludwigsburg-Bietigheim
  - Ludwigshafen, Germany, 67071
    - Kardiologische Praxisklinik Ludwigshafen
  - Löhne, Germany, 32584
    - Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet
  - Lübeck, Germany, 23538
    - Universität zu Lübeck
  - Magdeburg, Germany, 39110
    - Institut für Präventive Medizin & Klinische Forschung GbR
  - Mainz, Germany, 55131
    - Katholisches Klinikum Mainz
  - Mainz, Germany, 55131
    - Universitätsklinikum Mainz
  - Mainz, Germany, 55122
    - Cardiopraxis Mainz
  - Mannheim, Germany, 68165
    - ZE:RO Praxen
  - Mannheim, Germany, 68167
    - UMM Mannheim
  - Markkleeberg, Germany, 04416
    - Kardiologische Praxis
  - Meiningen, Germany, 98617
    - Praxis Ben-Chur
  - Moers, Germany, 47441
    - Praxis Haj-Yehia
  - Mühldorf, Germany, 84453
    - Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte
  - Mühldorf, Germany, 84453
    - Kardiologie Mühldorf am Inn
  - Mülheim, Germany, 45468
    - Herzquartier Mülheim
  - München, Germany, 80634
    - Kardiologie Neuhausen-Nymphenburg
  - München, Germany, 80799
    - Dres. Wauer/Windstetter
  - Münster, Germany, 48149
    - Universitätsklinikum Münster
  - Münster, Germany, 48143
    - Praxis Kiepenkerl
  - Münster, Germany, 48143
    - Zentrum für Kardiologie an der Raphaelsklinik Münster
  - Münster, Germany, 48149
    - Praxis für Innere Medizin Münster
  - Neu-Isenburg, Germany, 63263
    - Internistische Praxisgemeinschaft
  - Northeim, Germany, 37154
    - Kardiologische Praxis Northeim
  - Oer-Erkenschwick, Germany, 45739
    - Hausarztpraxis
  - Paderborn, Germany, 33098
    - St. Vincenz-Krankenhaus GmbH
  - Papenburg, Germany, 26871
    - Kardiologische Praxis Papenburg - Site 6071
  - Papenburg, Germany, 26871
    - Kardiologische Praxis Papenburg - Site 6072
  - Passau, Germany, 94032
    - Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan
  - Pirna, Germany, 01796
    - Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH
  - Potsdam, Germany, 14469
    - VieSante Herzmedizin Potsdam
  - Potsdam, Germany, 14471
    - Kardiologische Gemeinschaftspraxis
  - Potsdam, Germany, 14467
    - Kinikum Ernst von Bergmann
  - Radebeul, Germany, 01445
    - Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann
  - Radebeul, Germany, 01445
    - Internistisch hausärtzliche Gemeinschaftspraxis Dr. Hildebrandt & Dr. Mutscher
  - Riesa, Germany, 01587
    - Gemeinschaftspraxis Herz Riesa
  - Rostock, Germany, 18057
    - Universitätsmedizin Rostock
  - Schwerin, Germany, 19057
    - MVZ Schwerin West GmbH
  - Schwäbisch Hall, Germany, 74523
    - Facharztpraxis für Kardiologie und Innere Medizin
  - Seehausen, Germany, 39615
    - Nierenzentrum Altmark
  - Siegen, Germany, 57072
    - Zentrum für Prävention und Rehabilitation
  - Singen, Germany, 78224
    - Klinik Singen
  - Sonneberg, Germany, 96515
    - MEDINOS Klinik Sonneberg
  - Straubing, Germany, 94315
    - Kardiologische Praxis im Steiner Thor
  - Straubing, Germany, 94315
    - Praxis Dr Knöbel u. Partner
  - Strausberg, Germany, 15344
    - Praxis Dr. Michael Rother
  - Trier, Germany, 54292
    - Krankenhaus der Barmherzigen Brüder Trier
  - Trier, Germany, 54292
    - Diabetologische Schwerpunktpraxis
  - Ulm, Germany, 89077
    - Studienzentrum der Herzklinik Ulm GbR
  - Unterwellenborn, Germany, 07333
    - Praxis Dr. Hansen
  - Ursensollen, Germany, 92289
    - Praxis Dr. Dengler/Hohenstatt
  - Völklingen, Germany, 66333
    - Herzzentrum Saar
  - Weinheim, Germany, 69469
    - GRN Weinheim
  - Wermsdorf, Germany, 04779
    - Kardiologische Praxis Al-Zoebi
  - Weyhe, Germany, 28844
    - Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße
  - Witten, Germany, 58455
    - Forschungszentrum-Ruhr / KliFoCenter GmbH
  - Wittenberg, Germany, 06886
    - Kardiologische Praxis Tamm/Hoh
  - Wolmirstedt, Germany, 39326
    - Kardiologische Fachpraxis
  - Wuppertal, Germany, 42103
    - Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue
  - Würzburg, Germany, 97080
    - Universitatsklinikum Wurzburg
  - Zwiesel, Germany, 94227
    - Gemeinschaftspraxis am Angerbrunnen
Italy
- - Acquaviva delle Fonti, Italy, 70021
    - Ospedale Generale Regionale "F. Miulli"
  - Agrigento, Italy, 92100
    - P.O. Agrigento Ospedale San Giovanni di Dio
  - Ancona, Italy, 60127
    - IRCCS-INRCA Ancona
  - Anzio, Italy, 00042
    - Ospedale di Anzio
  - Ariccia, Italy, 00072
    - Ospedale dei Castelli
  - Ascoli Piceno, Italy, 63100
    - Ospedale "C. e G. Mazzoni"
  - Avellino, Italy, 83100
    - A.O. San Giuseppe Moscati
  - Avezzano, Italy, 67051
    - Ospedale SS Nicola e Filippo
  - Bari, Italy, 70123
    - Ospedale S. Paolo
  - Bari, Italy, 70124
    - A.O.U. Consorziale - Policlinico Bari
  - Bari, Italy, 70124
    - Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08016
  - Bari, Italy, 70124
    - Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari - Site 08017
  - Bentivoglio, Italy, 40010
    - AUSL Bologna Ospedale di Bentivoglio
  - Bergamo, Italy, 24127
    - Asst Papa Giovanni Xxiii
  - Bologna, Italy, 40133
    - Ospedale Maggiore Carlo Alberto Pizzardi
  - Bologna, Italy, 40138
    - Policlinico Sant'Orsola Bologna-Malpighi
  - Bolzano, Italy, 39100
    - Ospedale di Bolzano - Site 08070
  - Bolzano, Italy, 39100
    - Ospedale di Bolzano - Site 08112
  - Brescia, Italy, 25123
    - Spedali Civili di Brescia
  - Casale Monferrato, Italy, 15033
    - Ospedale Santo Spirito Casale Monferrato
  - Caserta, Italy, 81100
    - A.O. S. Anna e S. Sebastiano
  - Castelfranco Veneto, Italy, 31033
    - ULLS 2 MARCA TREVIGIANA Ospedale di Castelfranco Veneto
  - Catania, Italy, 95126
    - Azienda Ospedaliera Cannizzaro
  - Catania, Italy, 95124
    - AOU Policlinico Vittorio Emanuele Presidio Ospedaliero Gaspare Rodolico
  - Catanzaro, Italy, 88100
    - L'Azienda Ospedaliero-Universitaria "Renato Dulbecco" di Catanzaro
  - Cava de' Tirreni, Italy, 84013
    - Ospedale Civile Santa Maria Incoronata dell'Olmo
  - Chieti, Italy, 66100
    - Policlinico SS. Annunziata
  - Cirié, Italy, 10073
    - ASL TO4 Presidio Riunito di Ciriè-Lanzo
  - Cona, Italy, 44124
    - Azienda Ospedaliero-Universitaria di Ferrara "Arcispedale Sant'Anna"
  - Coppito, Italy, 67100
    - Ospedale San Salvatore
  - Florence, Italy, 50122
    - Ospedale Santa Maria Nuova
  - Florence, Italy, 50134
    - AOU Careggi - Site 08067
  - Florence, Italy, 50134
    - AOU Careggi - Site 08081
  - Florence, Italy, 50134
    - AOU Careggi - Site 08090
  - Foggia, Italy, 71122
    - Azienda Ospedaliera Universitaria "Ospedali Riuniti" di Foggia
  - Genova, Italy, 16132
    - Ospedale Policlinico San Martino
  - Genova, Italy, 16153
    - Presidio Ospedaliero S.O. Padre Antero Micone
  - Grosseto, Italy, 58100
    - Ospedale della Misericordia
  - La Spezia, Italy, 19121
    - Ospedale Sant'Andrea
  - Lamezia Terme, Italy, 88046
    - ASP Catanzaro Presidio Ospedaliero "Giovanni Paolo II"
  - Lecce, Italy, 73100
    - Ospedale Vito Fazzi
  - Legnago, Italy, 37045
    - Ospedale Mater Salutis
  - Matera, Italy, 75100
    - Presidio Ospedaliero "Madonna delle Grazie"
  - Melfi, Italy, 85025
    - Presidio ospedaliero San Giovanni di Dio
  - Messina, Italy, 98124
    - A.O.U. Policlinico "G. Martino"
  - Mestre, Italy, 30174
    - ULSS 3 SERENISSIMA Ospedale dell'Angelo
  - Milan, Italy, 20138
    - Centro Cardiologico Monzino
  - Milan, Italy, 20162
    - Ospedale Niguarda
  - Milan, Italy, 20162
    - ASST Grande Ospedale Metropolitano Niguarda
  - Milan, Italy, 20122
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08039
  - Milan, Italy, 20122
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Site 08097
  - Milan, Italy, 20149
    - Ospedale San Luca - Gruppo Istituto Auxologico Italiano
  - Mirano, Italy, 30035
    - ULSS 3 Serenissima Presidio Ospedaliero di Mirano
  - Modena, Italy, 41125
    - AOU Modena Policlinico Modena
  - Naples, Italy, 80131
    - A.O.R.N. Antonio Cardarelli
  - Naples, Italy, 80131
    - A.O.R.N. MONALDI OSPEDALE DEI COLLI Ospedale Monaldi
  - Naples, Italy, 80131
    - A.O.U. Federico II
  - Naples, Italy, 80131
    - Azienda Ospedaliera Specialistica dei Colli Ospedale Monaldi
  - Naples, Italy, 80131
    - Policlinico Università Federico II - Napoli
  - Nocera Inferiore, Italy, 84014
    - Ospedale Umberto I
  - Novara, Italy, 28100
    - AOU Maggiore della Carità di Novara
  - Novi Ligure, Italy, 15067
    - Ospedale San Giacomo
  - Padua, Italy, 35128
    - Azienda ospedaliera-Università di Padova
  - Palermo, Italy, 90127
    - A.O.U. Policlinico "P. Giaccone"
  - Palermo, Italy, 90133
    - Casa di Cura Triolo Zancla Hospital
  - Pavia, Italy, 27100
    - ICS Maugeri
  - Perugia, Italy, 06126
    - USL Umbria I
  - Perugia, Italy, 06129
    - Azienda Ospedaliera S. Maria della Misericordia di Perugia
  - Piacenza, Italy, 29121
    - Ospedale Guglielmo da Saliceto
  - Pisa, Italy, 56124
    - Fondazione Monasterio
  - Portogruaro, Italy, 30026
    - P. O. Portogruaro
  - Potenza, Italy, 85100
    - Azienda Ospedaliera Regionale San Carlo di Potenza
  - Prato, Italy, 59100
    - Nuovo Ospedale Santo Stefano
  - Ragusa, Italy, 97100
    - Azienda Sanitaria Provinciale di Ragusa Ospedale Giovanni Paolo II
  - Ravenna, Italy, 48121
    - Ospedale Santa Maria delle Croci
  - Rho, Italy, 20017
    - ASST Rhodense - Ospedale di Circolo di Rho
  - Rieti, Italy, 02100
    - Ospedale San Camillo De Lellis
  - Rimini, Italy, 47923
    - Ospedale Infermi AUSL Romagna
  - Rivoli, Italy, 10098
    - Ospedale degli Infermi di Rivoli
  - Roma, Italy, 00133
    - Policlinico Tor Vergata
  - Roma, Italy, 00161
    - Policlinico Umberto I
  - Roma, Italy, 00157
    - Ospedale Sandro Pertini
  - Roma, Italy, 00169
    - Policlinico Casilino
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08046
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Site 08121
  - Roma, Italy, 00189
    - AOU S. Andrea
  - Salerno, Italy, 84131
    - A.O. San Giovanni di Dio e Ruggi D'Aragona
  - Saronno, Italy, 21047
    - ASST Valle Olona P.O. Saronno
  - Sarzana, Italy, 19038
    - Ospedale S. Bartolomeo
  - Sassari, Italy, 07100
    - AOU Sassari Ospedale SS. Annunziata
  - Sesto San Giovanni, Italy, 20099
    - IRCCS MultiMedica
  - Siena, Italy, 53100
    - A.O.U. Senese Ospedale Santa Maria alle Scotte
  - Siena, Italy, 53100
    - AOU Senese- Policlinico Le Scotte
  - Taranto, Italy, 74121
    - Casa di cura Villa Verde
  - Terni, Italy, 05100
    - Azienda Ospedaliera Santa Maria
  - Torino, Italy, 10128
    - Ospedale Mauriziano Presidio Umberto I
  - Torrette, Italy, 60126
    - AOU Ospedali Riuniti di Ancona
  - Trento, Italy, 38122
    - Ospedale Santa Chiara
  - Treviso, Italy, 31100
    - ULLS 2 MARCA TREVIGIANA Ospedale Ca' Foncello
  - Trieste, Italy, 34149
    - Ospedale di Cattinara
  - Udine, Italy, 33100
    - Ospedale Santa Maria Della Misericordia
  - Urbino, Italy, 61029
    - Ospedale Santa Maria Della Misericordia
  - Varese, Italy, 21100
    - ASST Settelaghi Ospedale di Circolo e Fondazione Macchi
  - Verbania, Italy, 28922
    - Ospedale Castelli Verbania
Netherlands
- - Almelo, Netherlands, 7609 PP
    - ZGT
  - Amersfoort, Netherlands, 3813 TZ
    - Meander MC
  - Amsterdam, Netherlands, 1105 AZ
    - AUMC
  - Amsterdam, Netherlands, 8934 AD
    - MC Leeuwarden
  - Arnhem, Netherlands, 6815 AD
    - Rijnstate
  - Breda, Netherlands, 4818 CK
    - Amphia
  - Dordrecht, Netherlands, 3318 AT
    - Albert Schweitzer
  - Ede, Netherlands, 6716 RP
    - ZGV
  - Eindhoven, Netherlands, 5631 BM
    - Maxima Medisch Centrum
  - Gouda, Netherlands, 2803 HH
    - GHZ
  - Haarlem, Netherlands, 2035 RC
    - Spaarne Gasthuis
  - Hardenberg, Netherlands, 7772 SE
    - Saxenburgh Medisch Centrum
  - Hilversum, Netherlands, 1212 VG
    - Tergooi Mc
  - Hoogeveen, Netherlands, 7900 RA
    - Treant Bethesda Hoogeveen
  - Hoorn, Netherlands, 1624 NP
    - Dijklander
  - Leiderdorp, Netherlands, 2353 GA
    - Alrijne
  - Maastricht, Netherlands, 6229 HX
    - MUMC+
  - Rotterdam, Netherlands, 3015 GD
    - Erasmus MC
  - Rotterdam, Netherlands, 3045 PM
    - Franciscus Gasthuis
  - Rotterdam, Netherlands, 3079 DZ
    - Maasstad
  - Zwolle, Netherlands, 8025 AB
    - Isala Zwolle
Spain
- - Albacete, Spain, 02006
    - Hospital General de Albacete
  - Alcorcón, Spain, 28922
    - Hospital Universitario Fundacion Alcorcon
  - Alcoy, Spain, 03804
    - Hospital Virgen de los Lirios
  - Alicante, Spain, 03010
    - Hospital General Universitario Dr. Balmis
  - Almería, Spain, 04009
    - Hospital Universitario Torrecárdenas
  - Asturias, Spain, 33011
    - Hospital Universitario Central de Asturias
  - Asturias, Spain, 33202
    - Clínica Mapfre Salud Gijón
  - Asturias, Spain, 33410
    - Hospital Universitario San Agustin
  - Badajoz, Spain, 06010
    - Hospital Universitario Nuestra Señora del Perpétuo Socorro
  - Barakaldo, Spain, 48903
    - Hospital Universitario de Cruces
  - Barcelona, Spain, 08902
    - Hospital De Bellvitge
  - Bilbao, Spain, 48013
    - Hospital Universitario de Basurto
  - Burgos, Spain, 09003
    - Hospital Universitario de Burgos
  - Cadiz, Spain, 11009
    - Hospital Universitario Puerta Del Mar
  - Castellon, Spain, 12004
    - Hospital General Universitario de Castellon
  - Coslada, Madrid, Spain, 28822
    - Hospital del Henares
  - Cáceres, Spain, 10003
    - Hospital Universitario San Pedro de Alcantara
  - Córdoba, Spain, 14004
    - Hospital Universitario Reina Sofía
  - Denia, Spain, 03700
    - Hospital de Denia
  - Donostia / San Sebastian, Spain, 20014
    - Hospital Universitario de Donostia
  - Fuenlabrada Madrid, Spain, 28942
    - Hospital De Fuenlabrada
  - Gijón, Spain, 33394
    - Hospital Universitario de Cabueñes
  - Granada, Spain, 18016
    - Hospital Universitario San Cecilio
  - Granada, Spain, 18013
    - Hospital Universitario Virgen De Las Nieves
  - Huelva, Spain, 21110
    - Hospital Universitario Juan Ramón Jiménez
  - Jaén, Spain, 23007
    - Hospital Universitario Médico-Quirúrgico de Jaén
  - Jerez de La Frontera, Cádiz, Spain, 11407
    - Hospital Jerez de la Frontera
  - Las Palmas de Gran Canaria, Spain, 35010
    - Hospital Universitario de Gran Canaria Dr. Negrin
  - Las Palmas de Gran Canaria, Spain, 35016
    - Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria
  - León, Spain, 24008
    - Hospital Universitario de Leon
  - Logroño, Spain, 26006
    - Hospital San Pedro
  - Madrid, Spain, 28006
    - Hospital Universitario La Princesa
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28040
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28040
    - Hospital Clinico Universitario San Carlos
  - Madrid, Spain, 28007
    - Hospital Universitario Gregorio Maranon
  - Madrid, Spain, 28034
    - Hospital Ruber Internacional
  - Madrid, Spain, 28660
    - Hospital HM Montepríncipe
  - Madrid, Spain, 28850
    - Hospital Universitario de Torrejon
  - Majadahonda Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro Majadahonda
  - Majdahonda Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro Majadahonda
  - Marbella Málaga, Spain, 29603
    - Hospital Costa del Sol
  - Mendaro, Spain, 20850
    - Hospital de Mendaro
  - Murcia, Spain, 30120
    - Hospital Clinico Universitario Virgen Arrixaca
  - Murcia, Spain, 30003
    - Hospital General Universitario Reina Sofia
  - Málaga, Spain, 29010
    - Hospital Regional Universitario de Malaga
  - Málaga, Spain, 29010
    - Hospital Universitario Virgen de la Victoria
  - Málaga, Spain, 29002
    - Consulta de Cardiología Dr. Javier Mora Robles
  - Palma de Mallorca, Spain, 07193
    - Hospital Universitario Son Llatzer
  - Pamplona, Spain, 31008
    - Hospital Universitario de Navarra
  - Port de Sagunt, Spain, 46520
    - Hospital de Sagunto
  - Santander, Spain, 39008
    - Hospital Universitario Marqués de Valdecilla
  - Seville, Spain, 41014
    - Hospital De Valme
  - Seville, Spain, 411013
    - Hospital Universitario Virgen del Rocio
  - Toledo, Spain, 45007
    - Hospital General Universitario de Toledo
  - Valencia, Spain, 46026
    - Hospital Universitari i Politecnic La Fe
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova
  - Valencia, Spain, 46015
    - Vithas Valencia 9 de Octubre
  - Valencia, Spain, 46016
    - Consorcio Hospital General Universitario de Valencia
  - Valladolid, Spain, 47130
    - Hospital Universitario Rio Hortega
  - Villarreal, Castellón, Spain, 12540
    - Hospital de La Plana
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitaro Lozano Blesa
Switzerland
- - Baden, Switzerland, 5400
    - Diabetologie & Endokrinologie Baden
  - Basel, Switzerland, 4031
    - University Hospital Basel
  - Bern, Switzerland, 3010
    - Inselspital, Universitätsspital Bern
  - Binningen, Switzerland, 4102
    - Praxis Dr. med Urs Beat Gröflin
  - Davos, Switzerland, 7265
    - Hochgebirgsklinik Davos
  - Lachen, Switzerland, 8853
    - Spital Lachen AG
  - Lausanne, Switzerland, 1011
    - Centre Hospitalier Universitaire Vaudois (CHUV)
  - Lausanne, Switzerland, 1011
    - University of Lausanne
  - Liestal, Switzerland, 4410
    - Kantonsspital Baselland
  - Lugano, Switzerland, 6900
    - EOC Ente Ospedaliero Cantonale
  - Lugano, Switzerland, 6900
    - MIP Associazione Medico in Pratica c/o Studio Medico Cardiologico Acquistapace
  - Olten, Switzerland, 4600
    - Praxis Prof. Dr. med. Gottfried Rudofsky
  - Rennaz, Switzerland, 1847
    - HÔPITAL RIVIERA-CHABLAIS, VAUD-VALAIS, Centre hospitalier de Rennaz
  - Sankt Gallen, Switzerland, CH-9007
    - Kantonsspital St.Gallen
  - Thun, Switzerland, 3600
    - Spital Thun
  - Yverdon-les-Bains, Switzerland, 1400
    - Prof. Dr. med. Stephane Bosquet
  - Zurich, Switzerland, 8091
    - UniversitätsSpital Zürich
United Kingdom
- - Bath, United Kingdom, BA1 3NG
    - Royal United Hospitals Bath NHS Foundation Trust
  - Belfast, United Kingdom, BT16 1RH
    - South Eastern Ulster Hospital
  - Cardiff, United Kingdom, CF64 2XX
    - University Hospital of Wales
  - Chippenham, United Kingdom, SN15 2SB
    - Rowden Surgery
  - Craigavon, United Kingdom, BT63 5QQ
    - Craigavon Area Hospital
  - Darlington, United Kingdom, DL3 6HX
    - Darlington Memorial Hospital
  - Durham, United Kingdom, DH1 5TW
    - University Hospital North Durham
  - Hampshire, United Kingdom, PO8 8DL
    - Oaks Healthcare
  - Kendal, United Kingdom, LA9 7RG
    - West Morland General Hospital
  - Leicester, United Kingdom, LE19 4LY
    - North Blaby PCN
  - London, United Kingdom, W12 0HS
    - Hammersmith Hospital
  - London, United Kingdom, EC1M 6BQ
    - Barts Health NHS Trust/ QMUL
  - London, United Kingdom, NW10 4ST
    - Freuchen Medical Centre
  - London, United Kingdom, NW3 2QG
    - Royal Free Hospital Lipid Clinic
  - London, United Kingdom, W6 8RP
    - Imperial College London
  - Manchester, United Kingdom, M13 9WL
    - Manchester University NHS Foundation Trust
  - Manchester, United Kingdom, M13 9WL
    - Manchester Royal Infirmary
  - Manchester, United Kingdom, M23 9LT
    - Manchester University NHS Foundation Trust
  - Manchester, United Kingdom, M23 9LT
    - Wythenshawe Hospital
  - Middlesbrough, United Kingdom, TS4 3BW
    - STRIVE, The James Cook University Hospital
  - Northumbria, United Kingdom, TS19 8PE
    - North Tees Hospital
  - Nottingham, United Kingdom, NG5 1PB
    - City Hospital
  - Portsmouth, United Kingdom, PO6 3LY
    - Queen Alexandra Hospital
  - Prescot, United Kingdom, L35 5DR
    - Whiston Hospital
  - Salford, United Kingdom, M6 8HD
    - North Manchester General Hospital
  - Staffordshire, United Kingdom, DE13 0RB
    - Queen's Hospital Lipid Clinic
  - Telford, United Kingdom, TF1 6TF
    - Princess Royal Hospital
  - Torquay, United Kingdom, TQ2 7AA
    - Torbay and South Devon NHS Foundation Trust
  - Trowbridge, United Kingdom, BA14 8LW
    - Trowbridge Health Centre
  - Wales, United Kingdom, LL57 2PW
    - North Wales Cardiac Centre
  - Wansford, United Kingdom, PE8 6PL
    - Wansford and Kings Cliffe Practice
  - Watford, United Kingdom, WD18 7QR
    - Bridgewater Surgeries

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

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

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bempedoic acid and/or fixed-dose combination with ezetimibe Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.	Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)	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.	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)
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 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)		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)
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 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)	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.	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)
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 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)	Inflammatory status was assessed using high-sensitive C-reactive protein.	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)

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Investigators

Study Director: Global Clinical Leader, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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)

January 15, 2021

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DSE-BMP-01-20-EU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations