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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04271280
Other study ID # DSE-HCL-01-19-EU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 17, 2020
Est. completion date April 11, 2022

Study information

Verified date February 2024
Source Daiichi Sankyo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.


Description:

Suffering from hypercholesterolemia is a major health concern in Europe. Appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. Despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. As this is a non-interventional study, only data from routine clinical practice will be documented.


Recruitment information / eligibility

Status Completed
Enrollment 9559
Est. completion date April 11, 2022
Est. primary completion date April 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Very High Risk and High Risk dyslipidemic patients requiring LMTs - Not simultaneously participating in any interventional study - Providing written informed consent for participation in the study (Informed consent form) - Life expectancy > 1 year Exclusion Criteria: - Not applicable; non-interventional study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non-interventional
This is a non-interventional study.

Locations

Country Name City State
Austria Krankenhaus St. Josef Braunau GmbH Braunau Am Inn
Austria LKH-Univ. Klinikum Graz Graz
Austria Medizinische Universität Graz Graz
Austria Medizinische Universität Innsbruck Innsbruck
Austria KABEG Klinikum Klagenfurt am Wörthersee Klagenfurt
Austria Konventhospital der Barmherzigen Brüder Linz Linz
Austria Privatklinik Wehrle-Diakonissen Salzburg
Austria Ordination Universitätsdozent Dr. Alexander Kober Sankt Aegyd Am Neuwalde
Austria Ordination Dr. med. univ. Evelyn Fließer-Görzer Sankt Stefan
Austria Allgemeines Krankenhaus der Stadt Wien Wien
Austria Krankenhaus Hietzing mit neurologischem Zentrum Rosenhügel Wien
Austria Krankenhaus Nord - Klinik Floridsdorf Wien
Austria Krankenhaus Rudolfstiftung Wien
Austria Ordination Dr. Reinhard Sock Wien
Austria Ordination Dr. Thomas Maca / Evangelische KH Wien Wien
Austria Ordination Dr. Thomas Maca / Evangelisches KH Wien Wien
Austria Zentrum für Klinische Studien Dr. Hanusch GmbH Wien
Austria Internistische Facharztpraxis Frau Dr. Carmen Gelsinger Zams
Belgium ASZ Aalst
Belgium Imeldaziekenhuis Bonheiden
Belgium Clinique Saint-Luc Bouge
Belgium AZ KLINA Brasschaat
Belgium UZ Brussel Brussel
Belgium CHU Brugmann Bruxelles
Belgium CHU Saint Pierre Bruxelles
Belgium Cliniques de l'Europe Bruxelles
Belgium CUB Hospital Erasme Bruxelles
Belgium Private practice De Haan
Belgium Private practice De Pinte
Belgium AZ Sint Blasius Dendermonde
Belgium AZ Sint Lucas Gent
Belgium Universitair Ziekenhuis Gent Gent
Belgium Cabinet de médecine générale Gribomont
Belgium CH Jolimont-Lobbes Haine-Saint-Paul
Belgium CHR de Huy Huy
Belgium Jan Yperman Hospital Ieper
Belgium AZ Groeninge VZW Kortrijk
Belgium CHC Liège Liège
Belgium AZ Delta Roeselare
Belgium AZ Glorieux Ronse
Belgium Sint Trudo Sint-Truiden
Belgium Private practice Tienen
Belgium BVBA Dr CAPIAU Wetteren
Belgium CHU UCL Namur Yvoir
Belgium Z Sint Elisabeth Zottegem Zottegem
Denmark Amager Hospital Copenhagen
Denmark Bispebjerg-Frederiksberg Hospital Copenhagen
Denmark Bispebjerg/ Frederiksberg Hospital Copenhagen
Denmark Hjerteklinik Osterbro Copenhagen
Denmark Sydvestjysk Sygehus Esbjerg Esbjerg
Denmark Frederiksberg Hjerteklinik Frederiksberg
Denmark Frederiksberg Hjerteklinik Frederiksberg
Denmark Rigshospitalet (Copenhagen University Hospital) - Glostrup (Glostrup Hospital) Glostrup
Denmark Stroke center Rigshospitalet Glostrup
Denmark Gentofte Hospital Hellerup
Denmark Kobenhavns Universitet - Holbaek Sygehus Holbæk
Denmark Slagelse sygehus Slagelse
Finland Mehiläinen Leppävaara Espoo
Finland Geri-Med Oy Helsinki
Finland Pihlajalinna Dextra Helsinki
Finland Pihlajalinna (Site 04-007) Joensuu
Finland Pihlajalinna (Site 04-022) Joensuu
Finland StudyCor Oy Jyväskylä
Finland Terveystalo Kalajoki Kalajoki
Finland Aava Kerava Medical Center Kerava
Finland Terveystalo Kokkola Kokkola
Finland Mehiläinen Kuopio Kuopio
Finland Lappeenrannan Työterveys - Site 4024 Lappeenranta
Finland Lappeenrannan Työterveys - Site 4025 Lappeenranta
Finland Terveystalo Loimaa
Finland Oulu University Hospital Oulu
Finland Satasairaala Pori
Finland Sastamalan seudun sosiaali- ja terveyspalvelut Sastamala
Finland Seinäjoki Central Hospital Seinäjoki
Finland Tampere University Hospital Tampere
Finland Terveystalo Tampere Tampere
Finland Mehiläinen Turku Kauppiaskatu Turku
Finland Turku University Hospital Turku
Finland Turku University Hospital Turku
Finland Finla Työterveys Vantaa Vantaa
Finland Terveystalo Myyrmäki (Site 04015) Vantaa
Finland Terveystalo Myyrmäki (Site 04017) Vantaa
France 4 Rue Larrey Angers
France Cabinet médical Louis Blanc Anzin
France Clinique d'Argonay Argonay
France Hôpital Henri Duffaut Avignon
France Centre de Cardiologie et d'exploration de la Côte Basque Bayonne
France 151 rue Georges Clémenceau Breteuil
France 4 Rue du Capitaine Drillien Chalon-sur-Saône
France Centre Hospitalier de Chateauroux Châteauroux
France CH Compiègne Compiègne
France Centre Hopsitalier Alpes Leman, 552 Route de Findrol Contamine-sur-Arve
France 619 Rue de Saint Vaast Flesselles
France CHU Grenoble Grenoble
France 2 Boulevard Victor Hugo Istres
France 2 Rue du Dr Schweitzer La Rochelle
France Hôpital Louis Pasteur Le Coudray
France 222 Avenue du Mont Gaillard Le Havre
France Hôpital Marie Lannelongue Le Plessis-Robinson
France Institut Cœur Poumons, Boulevard du Pr Leclercq Lille
France Centre Hospitalier de Lisieux, 4 Rue Roger Aini Lisieux
France Centre Hospitalier La Timone Marseille
France Clinique de Meudon Meudon-la-Forêt
France Clinique du Pont de Chaume Montauban
France Clinique du Millénaire Montpellier
France Centre Hospitalier Universitaire de Nantes Nantes
France Hôpital Guillaume et René Laennec Nantes Cedex 1
France Centre Hospitalier de Nice Nice
France CHU Carémeau Nîmes
France Cabinet de cardiologie Paris
France Cabinet médical du docteur Cohen Paris
France Hôpital Pitié Salpétrière Paris
France Centre Hospitalier de Pau Pau
France Clinique Sant Hilaire Rouen
France 82 Avenue de Pontaillac Royan
France Hôpital Sainte Musse Toulon
France Centre Hospitalier Toulouse Toulouse
France Hôpital Guy Chatillez Tourcoing
Germany Downtown Clinic Aachen Aachen
Germany Kardiologische Praxis Aachen Aachen
Germany Praxis Delonge Aachen
Germany Kliniken an der Paar - Krankenhaus Aichach Aichach
Germany Oberpfalz Research GbR Amberg
Germany MVZ Aue Aue
Germany Kardiologische Praxis Bad Elster
Germany Kardiologische Praxis Bad Homburg
Germany Universitäts-Herz-Zentrum Freiburg-Bad Krozingen Bad Krozingen
Germany Kerckhoff-Klinik Forschungsgesellschaft mbH Bad Nauheim
Germany Herz - u. Diabeteszentrum NRW Bad Oeynhausen
Germany Praxis am Landratspark Bad Segeberg
Germany Gemeinschaftspraxis für Herz und Lunge Bamberg
Germany Kardiologische Praxis Bechhofen
Germany Charité Campus Virchow Berlin
Germany Diabetespraxis Prenzlauer Allee Berlin
Germany Kardiologische Facharztpraxis Dr. Anne Winkelmann Berlin
Germany MVZ Dres. Ramdohr - Praxis für Cardiovascular und Ultraschalldiagnostik Berlin
Germany Praxis Dr. Matthias Claus Berlin
Germany Praxis Rankestraße Berlin
Germany Vivantes Humboldt-Klinikum Berlin
Germany Vivantes Klinikum Spandau Berlin
Germany Marienhaus-Klinikum Eifel Bitburg Bitburg
Germany Städtisches Klinikum Brandenburg Brandenburg an der Havel
Germany Kardiologie an der Paulikirche Braunschweig
Germany Kardiologie im Friedrichspalast Bruchsal Bruchsal
Germany MediClin Reha-Zentrum Spreewald Burg (Spreewald)
Germany Kardiologische Praxis Chemnitz
Germany MVZ am Küchwald Chemnitz
Germany MVZ Polymed Chemnitz
Germany Praxis Dipl.med Schermaul Chemnitz
Germany St. Josefs-Hospital Cloppenburg Cloppenburg
Germany Klinikum Coburg GmbH Coburg
Germany Praxis Dr. Menzel Dessau
Germany Klinikum Lippe GmbH Detmold
Germany Kardiologische Gemeinschaftspraxis Dortmund
Germany Kardiologische Gemeinschaftspraxis Dres. Wetzel/Willgeroth Dortmund
Germany Sankt-Johannes-Hospital Dortmund
Germany Dres. Günther/Kolschmann Dresden
Germany Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH Dresden
Germany Praxis Dr. Methfessel Dresden
Germany Praxis Dres. Jänsch/Varnai Dresden
Germany Studienzentrum Dr. Faulmann Dresden
Germany Universitätsklinikum Carl Gustav Carus Dresden
Germany Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR Dresden
Germany Praxis Dipl. - Med. Petra Herrmann - Fachärztin für Innere Medizin Eisenach
Germany Kardiologische Praxis Elsterwerda
Germany Elisabeth Krankenhaus Essen Essen
Germany Medizentrum Essen Borbeck Essen
Germany Universitätsklinikum Essen Essen
Germany Klinikum Frankfurt Hoechst GmbH Frankfurt
Germany MVZ Altstadt-Carree Fulda GmbH Fulda
Germany Evangelisches Krankenhaus Gelsenkirchen Gelsenkirchen
Germany Kardiologische Praxis Gera
Germany Praxis für Gefäßmedizin Görlitz
Germany Kardiologische Praxis Gotha
Germany Universitätsmedizin Göttingen Göttingen
Germany Praxis für Herzkreislauferkrankungen Greiz Greiz
Germany Evangelisches Krankenhaus Hagen-Haspe Hagen
Germany Gemeinschaftspraxis Dres. J. Hintze und M. Grundner Hainstadt
Germany Cardiologicum Hamburg-Wandsbek Hamburg
Germany Kardiologie am Tibarg Hamburg
Germany MVZ Prof. Detlef Mathey, Prof. Schofer GmbH Hamburg
Germany Kardiologische Praxis Hanover
Germany Kardiologische Praxis Haßloch
Germany Kardiologische Schwerpunktpraxis Heidelberg
Germany Praxis für Angiologie und Hämatologie Heidelberg
Germany Uniklinikum Heidelberg Heidelberg
Germany Praxis Homburg
Germany Kardiologie Oberschwaben - Bodensee Herz- und Gefäßpraxis Isny Im Allgäu
Germany Kardiologische Praxis Jena
Germany Kardiopraxis Schirmer Kaiserslautern
Germany Kardiologie/Internistenteam Kamen Kamen
Germany SRH Klinikum Karlsbad-Langensteinbach Karlsbach
Germany B. Braun Ambulantes Herzzentrum MVZ GmbH Kassel
Germany CC Cleve-Studiencenter Kleve
Germany MVZ Gesundes Herz Köln
Germany Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz Konstanz
Germany Praxis für Innere Medizin / Kardiologie - Dr. med. E. Persicke / Dr. med. O. Scheuermann Kornwestheim
Germany Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut Leipzig
Germany Kardiologische Gemeinschaftspraxis Leipzig
Germany MediClin MVZ Leipzig Leipzig
Germany MVZ Stoffwechselmedizin Leipzig Leipzig
Germany Praxis für Gefäßerkrankungen und Gerinnungsstörungen Leipzig Leipzig
Germany Universitätsklinikum Leipzig Leipzig
Germany Kardiologische Fachpraxis Lengerich
Germany Praxis Dr. med. Ilka Simon-Wagner Lichtenfels
Germany St. Vincenz-Krankenhaus Limburg
Germany Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet Lohne
Germany Kardiologische Praxis Lohne Lohne
Germany Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet Löhne
Germany Klinikum Lüdenscheid Lüdenscheid
Germany Cardio Centrum Ludwigsburg-Bietigheim Ludwigsburg
Germany Kardiologische Praxisklinik Ludwigshafen Ludwigshafen
Germany Dres. Erdmann/Schütz/Sicken Lünen
Germany St.Vincenz - u. Elisabeth-Hospital Mainz
Germany Universitätsklinikum Mainz Site 6186 Mainz
Germany Universitätsklinikum Mainz Site 6187 Mainz
Germany Universitätsklinikum Mannheim Mannheim
Germany zero Praxen Mannheim Mannheim
Germany Kardiologische Praxis Markkleeberg
Germany Praxis Dr. Ben-Chur Meiningen
Germany Kardiologie-Praxis Moers
Germany Gemeinschaftspraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte Mühldorf
Germany Herzquartier Mühlheim, Kardiologische Gemeinschaftspraxis Dres. med. A. Krapivsky & P. Kekes Mühlheim
Germany Praxis für Innere Medizin Münster
Germany Universitätsklinikum Münster Münster
Germany Zentrum für Diabetes und Gefäßerkrankungen Münster Münster
Germany Praxis für Innere Medizin und Angiologie Nordhausen
Germany Kardiologische Praxis Northeim Northeim
Germany Gemeinschaftspraxis Drs. Haggenmiller/Jeserich Kardiologie-Angiologie-Innere Medizin Nürnberg
Germany Kardiologie am Weißen Turm Nürnberg
Germany St. Vincenz-Krankenhaus GmbH Paderborn
Germany Kardiologische Praxis Panitzsch
Germany Kardiologische Praxis Papenburg (Site 6097) Papenburg
Germany Kardiologische Praxis Papenburg (Site 6098) Papenburg
Germany Kardiologische Praxis Pirmasens
Germany Cardiologicum Dresden/Pirna Pirna
Germany Kardiologie Potsdam Potsdam
Germany Kardiologische Gemeinschaftspraxis Potsdam Potsdam
Germany Paracelsus-Harz-Klinik Bad Suderode Quedlinburg
Germany Drs. Bauer/Buresch/Kösler Regensburg
Germany Gemeinschaftspraxis Herz Riesa Riesa
Germany Universitätsmedizin Rostock Rostock
Germany Zentrum für Prävention und Rehabilitation Siegen
Germany Kardiologische Praxis Stahnsdorf
Germany Praxis Dr. Birkenhagen Stollberg
Germany Drs. Knoebel @ Partner Straubing
Germany Praxis Dr. Michael Rother Strausberg
Germany Diabetologische Schwerpunktpraxis Trier
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Germany Studienzentrum der Herzklinik Ulm GbR Ulm
Germany Praxis Dr. Sabine Hansen Unterwellenborn
Germany Praxis für Prävention und Therapie Villingen-Schwenningen
Germany SHG Klinik Völklingen Völklingen
Germany GRN Klinik Weinheim Weinheim
Germany Forschungszentrum-Ruhr KliFoCenter GmbH Witten
Germany Klinikum Worms Worms
Germany Praxis Dr. Woitek Wurzen
Germany Praxis T. Schwarz Zwenkau
Ireland Beaumont Hospital Beaumont Dublin
Ireland Cork University Hospital Cork
Ireland Beacon Hospital Dublin
Ireland Mater Private Hospital Dublin
Ireland St. James Hospital Dublin
Ireland Turloughmore Health Centre Galway
Ireland Tramore Medical Clinic Tramore Waterford
Italy INRCA -Ospedale U. Sestilli di Ancona Ancona Marche
Italy Ospedali Riuniti "Umberto I - Lancisi - Salesi Ancona Marche
Italy ASL Roma 6 - Ospedali Riuniti Anzio - Nettuno Anzio Lazio
Italy Ospedale di Arzignano Arzignano Veneto
Italy Presidio ospedaliero Cardinal Massaia - A.S.L. AT (SOC Diabetologia e Malattie Metaboliche) Asti Piemonte
Italy A.O. San Giuseppe Moscati Avellino Campania
Italy A.O. San Giuseppe Moscati (U.O.C. Cardiologia/UTIC) Avellino Campania
Italy A.O.U. Consorziale - Policlinico Bari Bari Puglia
Italy A.O.U. Consorziale - Policlinico Bari (Dipartimento di Medicina Interna) Bari Puglia
Italy Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli" Bari Puglia
Italy A.O.R.N. San Pio - P.O. RUMMO Benevento Campania
Italy Ospedale di Bentivoglio Bentivoglio Emilia Romagna
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo Lombardia
Italy A.O.U di Bologna-Policlinico S.Orsola-Malpighi (U.O. Medicina Interna) Bologna Emilia Romagna
Italy Ospedale Maggiore di Bologna Bologna Emilia Romagna
Italy Policlinico Sant'Orsola-Malpighi (U.O. Cardiologia) Bologna Emilia Romagna
Italy Ospedale di Bolzano (U.O. Cardiologia e Prove Funzionali) Bolzano Trentino Alto Adige
Italy ASST Spedali Civili P.O di Brescia Brescia Lombardia
Italy Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (U.O Medicina Generale 2) Brescia Lombardia
Italy Fondazione Poliambulanza Istituto Ospedaliero - Brescia Brescia Lombardia
Italy Ospedale di Carpi Carpi Emilia Romagna
Italy Azienda Ospedaliera di Rilievo Nazionale(A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta Caserta Campania
Italy Ospedale Cannizzaro Catania Sicilia
Italy Azienda Ospedaliera Universitaria Mater Domini - Site 8042 Catanzaro Calabria
Italy Azienda Ospedaliera Universitaria Mater Domini - Site 8053 Catanzaro Calabria
Italy Azienda Ospedaliera Universitaria Mater Domini - Site 8059 Catanzaro Calabria
Italy Ospedale Civile Santa Maria Incoronata dell'Olmo Cava Dè Tirreni Campania
Italy Ospedale Civile SS. Annunziata (MEDICINA INTERNA- DIPARTIMENTO DI MEDICINA E SCIENZE DELL'INVECCHIAMENTO) Chieti Abruzzo
Italy Ospedale San Giuseppe Empoli Toscana
Italy Arcispedale Sant'Anna Ferrara (U.O. Cardiologia) Ferrara Emilia Romagna
Italy Azienda Ospedaliera-Universitaria S. Anna di Ferrara (Dipartimento medico) Ferrara Emilia Romagna
Italy A.O.U. Careggi (S.O.D. Malattie Aterotrombotiche) - Site 8020 Firenze Toscana
Italy A.O.U. Careggi - Site 8041 Firenze Toscana
Italy A.O.U. Careggi - Site 8093 Firenze Toscana
Italy A.O.U. Ospedali Riuniti Foggia Puglia
Italy Presidio Ospedaliero Vito Fazzi Lecce Puglia
Italy Ospedale Mater Salutis Legnago Veneto
Italy Ospedale Macerata Macerata Marche
Italy Ospedale S. Andrea - Usl Toscana Sud Est Massa Marittima Toscana
Italy A.O.U. Policlinico "G. Martino" (U.O. Cardiologia) Messina Sicilia
Italy Centro Cardiologico Monzino - IRCCS Milano Lombardia
Italy Centro Cardiologico Monzino - IRCCS (Unità Prevenzione dell'Aterosclerosi) Milano Lombardia
Italy Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico Milano Lombardia
Italy Grande Ospedale Metropolitano di Niguarda Milano Lombardia
Italy IRCCS Istituto Ortopedico Galeazzi Milano Lombardia
Italy IRCCS Multimedica Milano Lombardia
Italy Istituto Clinico Sant'Ambrogio Milano Lombardia
Italy Presidio Ospedaliero di Mirano - ULSS 3 Serenissima Mirano Veneto
Italy A.O.U. Policlinico di Modena Modena Emilia Romagna
Italy Ospedale Civile di Baggiovara- AOU di Modena Modena Emilia Romagna
Italy Ospedale Regina Montis Regalis Mondovì Piemonte
Italy A.O.R.N. Cardarelli Napoli Campania
Italy A.O.R.N. Ospedale dei Colli Napoli Campania
Italy A.O.U. Federico II Napoli Campania
Italy A.O.U. FEDERICO II (U.O.C. Diabetologia) Napoli Campania
Italy Ospedale Buccheri La Ferla Palermo Sicilia
Italy Triolo Zancle Hospital Palermo Sicilia
Italy A.O. Santa Maria della Misericordia Perugia Umbria
Italy USL Umbria I Perugia Umbria
Italy Ospedale SS Cosma e Damiano di Pescia - Azienda Usl Toscana centro Pescia Toscana
Italy Ospedale Guglielmo da Saliceto Piacenza Emilia Romagna
Italy Ospedale Unico della Valtidone Piacenza Emilia Romagna
Italy Fondazione Toscana Gabriele Monasterio Pisa Toscana
Italy Ospedale Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria Pisana Pisa Toscana
Italy Università di Pisa Pisa Toscana
Italy Ospedale di Santo Stefano di Prato - Azienda Usl Toscana centro (UO di Cardiologia) Prato Toscana
Italy Ospedale Santo Stefano di Prato - Azienda Usl Toscana Centro Prato Toscana
Italy Ospedale Giovanni Paolo II Ragusa Sicilia
Italy Arcispedale Santa Maria Nuova - Azienda USL/IRCCS Reggio Emilia Reggio Emilia Emilia Romagna
Italy Azienda Ospedaliera San Giovanni Addolorata Roma Lazio
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Lazio
Italy Ospedale dei Castelli - ASL Roma 6 Roma Lazio
Italy Ospedale Policlinico Casilino Roma Lazio
Italy Policlinico Umberto I Roma Lazio
Italy Policlinico Universitario Campus Bio-Medico Roma Lazio
Italy A.O.U. "San Giovanni di Dio e Ruggi d'Aragona" Salerno Campania
Italy Ospedale Civile SS Annunziata (Dipartimento di Medicina Clinica e Sperimentale) Sassari Sardegna
Italy Ospedale Civile San Rocco Sessa Aurunca Campania
Italy Azienda Ospedaliero-Universitaria Senese Dipartimento Delle Scienze Mediche U.O.C. Medicina Interna e della Complessità Siena Toscana
Italy Ospedale Le Scotte Siena Toscana
Italy A.O.U. Città della Salute e della Scienza di Torino Torino Piemonte
Italy Ospedale degli Infermi di Rivoli Torino Piemonte
Italy Presidio Ospedaliero "Santa Maria della Misericordia" di Udine Udine Friuli
Italy Ospedale dei Castelli Verbania Piemonte
Italy Ospedale G. Jazzolino Vibo Valentia Calabria
Netherlands Ziekenhuis Groep Twente (ZGT) Almelo
Netherlands ZiekenhuisGroepTwente, Zilvermeeuw 1 Almelo
Netherlands Meander Medical Center Amersfoort
Netherlands Meander Medisch Centrum, Maatweg 3 Amersfoort
Netherlands Bovenij Zekenhuis Amsterdam
Netherlands Albert Schweitzerlaan 31 Apeldoorn
Netherlands Gelre Ziekenhuis Apeldoorn
Netherlands Tergooi Blaricum
Netherlands IJsselland Ziekenhuis Capelle Aan Den IJssel
Netherlands Ijsselland Ziekenhuis, Prins Constanijnweg 2 Capelle Aan Den IJssel
Netherlands Reinier de Graafweg 5 Delft
Netherlands Els Borst Den Haag
Netherlands Nico Bolkesteinlaan 75 Deventer
Netherlands Van Weel Bethesda Dirksland
Netherlands Slingeland Doetinchem
Netherlands Gelderse Vallei Ede
Netherlands Medisch Spectrum Twente Enschede
Netherlands Admiraal de Ruijten Ziekenhuis Goes
Netherlands Groene Hart Gouda Gouda
Netherlands Boerhaavelaan 22 Haarlem
Netherlands Ropcke Zweers hospital, Jan Weitkamplaan 4-a Hardenberg
Netherlands Saxenburgh Medisch Centrum Hardenberg
Netherlands Ziekenhuis St Jansdal Harderwijk
Netherlands Jeroen Bosch Hospital Herzogenbusch
Netherlands Dr G.H. Amshoffweg 1 Hoogeveen
Netherlands Treant Zorggroep Hoogeveen
Netherlands LUMC Leiden
Netherlands Ikazai Ziekenhuis Rotterdam
Netherlands Rivierenland ziekenhuis Tiel Tiel
Netherlands ETZ Tilburg
Netherlands Nistelrodeseweg 10 Uden
Netherlands Diakonessenhuis Utrecht Utrecht
Netherlands University Medical Center Utrecht Utrecht
Netherlands Maxima Medisch Centrum Veldhoven
Netherlands Zaans Medisch Centrum Zaandam
Portugal Instituto do Coração Carnaxide
Portugal Centro Hospitalar Universitario do Algarve Faro
Portugal Associação Protetora de Diabéticos de Portugal Lisbon
Portugal Centro Hospitalar Lisboa Norte - Site 10005 Lisbon
Portugal Centro Hospitalar Lisboa Norte - Site 10006 Lisbon
Portugal Hospital Egas Moniz (CHLO) Lisbon
Portugal Hospital Lusíadas de Lisboa, Lisboa Lisbon
Portugal Clínica Cuida Mais Mangualde
Portugal Centro Hospitalar Universitário São João (CHUSJ) Porto
Portugal Instituto CUF Porto Porto
Portugal Centro Hospitalar de Entre Douro e Vouga Santa Maria Da Feira
Spain Hospital Principe de Asturias Alcalá De Henares Madrid
Spain Hospital Universitario Fundación Alcorcón Alcorcón
Spain H. San Eloy Barakaldo País Vasco
Spain H de la Santa Creu i Sant Pau Barcelona Cataluña
Spain H. Clinic i Provincial de Barcelona Barcelona Cataluña
Spain H. del Mar Site 11041 Barcelona
Spain H. del Mar Site 11065 Barcelona
Spain H. Univ. Basurto Bilbao
Spain H. Univ. Basurto Bilbao País Vasco
Spain H. Univ. de Basurto Bilbao País Vasco
Spain C S Colloto Colloto Castilla-León
Spain Centro de Salud Colloto Colloto
Spain Hospital de Alta Resolución de Sierra Norte Constantina Andalucía
Spain H. Reina Sofia Córdoba Andalucía
Spain Complejo Hospitalario Universitario A Coruña Coruña Galicia
Spain Hospital de Alta Resolución de Ecija Écija Andalucía
Spain Complejo Hospitalario Univ. El Ferrol Ferrol Galicia
Spain H. Universitario Fuenlabrada Fuenlabrada Madrid
Spain Hospital Univ. Getafe Getafe
Spain H Juan Ramón Jiménez de Huelva Huelva Andalucía
Spain H. Infanta Elena Huelva Andalucía
Spain Centro Médico Puerto Jerez De La Frontera Andalucía
Spain HG. Univ. De Jérez Jerez De La Frontera Andalucía
Spain Hospital de Jerez Jerez De La Frontera
Spain H. Universitari Bellvitge L'Hospitalet De Llobregat Cataluña
Spain Hospital Universitari de Bellvitge L'Hospitalet De Llobregat
Spain Clinica Privada Orotava La Orotava Canarias
Spain Hospital de Alta Resolución de Lebrija Lebrija Andalucía
Spain H Clínico de Salamanca León Castilla-León
Spain H Universitario De León León Castilla-León
Spain Clinica Universitaria de Navarra Madrid
Spain Clínica Universitaria de Navarra Madrid
Spain Fundación Jiménez Díaz Madrid
Spain Fundación Jiménez Díaz Madrid
Spain H Gregorio Marañon Madrid
Spain H. Univ. Clínico San Carlos Madrid
Spain H. Univ. La Paz-Carlos III Madrid
Spain H. Univ. Ramón y Cajal Madrid
Spain H. Universitario 12 de octubre Madrid
Spain H. Universitario La Paz-Carlos III Madrid
Spain Hospital La Paz-Carlos III Madrid
Spain Hospital Universitario de la Princesa Site 11054 Madrid
Spain Hospital Universitario de la Princesa Site 11062 Madrid
Spain Hospital Universitario de la Princesa Site 11075 Madrid
Spain Hospital Universitario Gregorio Marañon Madrid
Spain H Carlos Haya Málaga Andalucía
Spain H. Costa del Sol Marbella Málaga
Spain H. Clínico Virgen de la Arrixaca Murcia
Spain Complejo Hospitalario de Ourense Ourense Galicia
Spain Complejo Hospitalario Universitario de Ourense (CHOU) Site 11003 Ourense
Spain Complejo Hospitalario Universitario de Ourense (CHOU) Site 11052 Ourense
Spain H Universitario Central de Asturias Oviedo Asturias
Spain H. San Joan de Reus Reus
Spain Hospital Parc Tauli Sabadell
Spain C S de la Alamedilla Salamanca Castilla-León
Spain Hospital Clínico de Salamanca Salamanca
Spain H. Univ. Infanta Sofía San Sebastián De Los Reyes Madrid
Spain Hospital Universitario Infanta Sofía San Sebastián De Los Reyes
Spain Hospital de Sant Joan Despí Moisès Broggi Sant Joan Despí
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain H. Clínico Univ. Santiago de Compostela Santiago De Compostela Galicia
Spain H. General de Segovia Segovia Castilla-León
Spain Hospital General de Segovia Segovia
Spain H. San Agustín Sevilla Andalucía
Spain H. Univ. Virgen Macarena Sevilla Andalucía
Spain Hospital Universitario Virgen de la Macarena Sevilla
Spain Hospital Sant Pau i Santa Tecla Tarragona
Spain Hospital HM de Torrelodones Torrelodones
Spain H. Alta Resolución de Utrera Utrera Andalucía
Spain Hospital de Alta Resolución de La Janda Vejer de la Frontera Andalucía
Spain Complejo Asistencial de Zamora Zamora Castilla-León
Spain Centro de Salud Fuentes Norte Zaragoza
Sweden Falu Lasarett, Diab/Endo-mottagning Falun
Sweden Östra Sahlgrenska Universitetssjukhuset - Ostra Sjukhuse Göteborg
Sweden Sahlgrenska University Hospital Göteborg
Sweden Värmdö Vårdcentral Gustavsberg
Sweden Öbackakliniken Härnösand
Sweden Länssjukhuset Ryhov Jönköping
Sweden Capio Citykliniken Lund
Sweden Skåne University Hospital Malmö
Sweden Cityheart Stockholm
Sweden Karolinska University Hospital, Huddinge Stockholm
Sweden Södersjukhuset Stockholm Stockholm
Switzerland Kantonsspital Baden AG Baden
Switzerland Universitätsspital Basel Basel
Switzerland Hôpitaux Universitaires de Genève Geneve
Switzerland University of Lausanne Unisanté Lausanne
Switzerland Cardio Center Luzern Luzern
Switzerland Kardiolab Olten
Switzerland Solothurner Spitäler AG Olten
Switzerland Kantonsspital St. Gallen Saint Gallen
Switzerland Cardiologue FMH Yverdon-les-Bains
Switzerland Klinik Hirslanden Zürich
Switzerland Universitätsspital Zürich Zürich
United Kingdom The Atherstone Surgery Atherstone
United Kingdom Heart of Bath Medical Partnership Bath Somerset
United Kingdom Ormeau Clinical Trials Ltd Belfast Northern Ireland
United Kingdom Layton Medical Centre Blackpool
United Kingdom Waterloo Medical Care Blackpool
United Kingdom Glan Clwyd Hospital Bodelwyddan Wales
United Kingdom Brockwood Medical Practice Brockham Surrey
United Kingdom Ely Bridge Surgery Cardiff
United Kingdom Llanedeyrn Health Centre Cardiff
United Kingdom Carlisle Healthcare Carlisle North Cumbria
United Kingdom Lakeside Surgery Corby Northamptonshire
United Kingdom Craigavon Area Hospital Craigavon Armagh
United Kingdom Carmel Medical Practice Darlington County Durham
United Kingdom Holderness Health Surgery Hedon
United Kingdom Burbage Surgery Hinckley Leicestershire
United Kingdom Great Western Hospital Swindon Huddersfield Wiltshire
United Kingdom Huddersfield Hospital Huddersfield Yorkshire
United Kingdom Hull Royal Infirmary Hull
United Kingdom Sherbourne Medical Centre Leamington Spa Warwickshire
United Kingdom Manor Park Medical Practice Leicester East Midlands
United Kingdom Oak Tree Surgery Liskeard Cornwall
United Kingdom Liverpool Heart & Chest Hospital NHS Trust Liverpool Merseyside
United Kingdom Barts Health NHS Trust London Greater London
United Kingdom Breckland Alliance London Norfolk
United Kingdom Church End Medical London Greater London
United Kingdom Newquay Health Centre Newquay Cornwall
United Kingdom North Tyneside General Hospital North Shields Tyne And Wear
United Kingdom Danes Camp Medical Centre Northampton Northamptonshire
United Kingdom Temple Sowerby Medical Practice Penrith
United Kingdom The Alverton Practice Penzance Cornwall
United Kingdom Wansford and Kings Cliffe Practice Peterborough
United Kingdom Pickering Medical Practice Pickering North Yorkshire
United Kingdom Knowle House Surgery Plymouth Cornwall
United Kingdom The Adam Practice Poole Dorset
United Kingdom Panthera Preston Preston
United Kingdom The Boathouse Sugery Reading Berkshire
United Kingdom Clifton Medical Centre Rotherham South Yorkshire
United Kingdom Ecclesfield Group Practice Sheffield
United Kingdom Princess Royal Hospital Shrewsbury Shropshire
United Kingdom Staploe Medical Centre Soham Surrey
United Kingdom Southend University Hospital Southend Essex
United Kingdom Branch End Surgery Stocksfield Northumberland
United Kingdom Sunderland Royal Hospital Sunderland Tyne And Wear
United Kingdom Great Western Hospital Swindon Swindon Wiltshire
United Kingdom Huddersfield Hospital Swindon West Yorkshire
United Kingdom Princess Royal Hospital Telford Shropshire
United Kingdom Royal Cornwall Hospital Truro Cornwall
United Kingdom Whitby Group Practice Whitby North Yorkshire
United Kingdom Fellview Healthcare Whitehaven Cumbria
United Kingdom Royal Albert Edward Infirmary Wigan
United Kingdom The Friarsgate Practice Winchester Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Ireland,  Italy,  Netherlands,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants Blood plasma samples were used to assess LDL-C levels. Baseline up to 12 months post-enrollment
Primary Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) Clinical events were assessed based on information captured in patient files/medical records. Baseline up to 12 months post-enrollment
Secondary Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels. Baseline up to 12 months post-enrollment
Secondary Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants Blood plasma samples were used to assess Apolipoprotein B levels. Baseline up to 12 months post-enrollment
Secondary Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants Blood plasma samples were used to assess lipid Protein A levels. Baseline up to 12 months post-enrollment
Secondary Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants Blood plasma samples were used to assess hsCRP levels. Baseline up to 12 months post-enrollment
Secondary Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT The safety outcome measure reports clinical events based on information captured in patient files/medical records. Participants may have reported more than one clinical event associated with any LMT. Baseline up to 12 months post-enrollment
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