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Search / Trial NCT04579367

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

Launched by DAIICHI SANKYO EUROPE, GMBH, A DAIICHI SANKYO COMPANY · Oct 1, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hypercholesterolemia Mixed Dyslipidemia Bempedoic Acid And/Or Its Fixed Dose Combination With Ezetimibe

ClinConnect Summary

This clinical trial is investigating the use of a medication called bempedoic acid and its combination with another drug, ezetimibe, for patients with high cholesterol levels. Specifically, it focuses on individuals with primary hypercholesterolemia (a genetic condition that causes high cholesterol) or mixed dyslipidemia (a mix of high cholesterol and other lipid issues). The trial aims to understand how effective these treatments are in lowering a type of cholesterol known as LDL-C, which is often referred to as "bad" cholesterol, and to evaluate any changes in patients' heart health and overall well-being over time.

To be eligible for this study, participants should be at least 18 years old and have a confirmed diagnosis of high cholesterol or mixed lipid issues. They need to be treated or expected to be treated with bempedoic acid or the combination therapy at their doctor's discretion. Participants can expect regular follow-ups to monitor their cholesterol levels and any side effects they may experience. It's important to note that this study is observational, meaning it will observe how patients respond to these medications without changing their prescribed treatment plans.

Gender

ALL

Eligibility criteria

  • 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.

About Daiichi Sankyo Europe, Gmbh, A Daiichi Sankyo Company

Daiichi Sankyo Europe GmbH, a subsidiary of Daiichi Sankyo Company, is a leading global pharmaceutical organization dedicated to the research, development, and commercialization of innovative medicines. With a strong focus on addressing unmet medical needs, the company leverages its expertise in pharmaceuticals and biotechnology to advance therapies in oncology, cardiovascular diseases, and other therapeutic areas. Committed to enhancing patient outcomes through scientific excellence and collaboration, Daiichi Sankyo Europe GmbH plays a pivotal role in driving clinical trials and bringing transformative treatments to market in Europe and beyond.

Locations

Madrid, , Spain

Brescia, , Italy

Manchester, , United Kingdom

Lausanne, , Switzerland

Truro, , United Kingdom

Lincoln, , United Kingdom

Madrid, , Spain

Essex, , United Kingdom

Barcelona, , Spain

Madrid, , Spain

Basel, , Switzerland

Barcelona, , Spain

Rotterdam, , Netherlands

Madrid, , Spain

Madrid, , Spain

Santander, , Spain

Valencia, , Spain

Valencia, , Spain

Cádiz, , Spain

Milano, , Italy

London, , United Kingdom

Leipzig, , Germany

Düsseldorf, , Germany

Heidelberg, , Germany

Madrid, , Spain

Münster, , Germany

Manchester, , United Kingdom

Dresden, , Germany

Leuven, , Belgium

Villach, , Austria

Zürich, , Switzerland

Grosseto, , Italy

Nottingham, , United Kingdom

Eindhoven, , Netherlands

Chippenham, , United Kingdom

Trieste, , Italy

Paderborn, , Germany

Würzburg, , Germany

Mainz, , Germany

Albacete, , Spain

Lleida, , Spain

Barcelona, , Spain

Madrid, , Spain

Málaga, , Spain

Roma, , Italy

Udine, , Italy

Karlsbad, , Germany

Wien, , Austria

Sevilla, , Spain

Graz, , Austria

Innsbruck, , Austria

Limburg, , Germany

Lausanne, , Switzerland

Markkleeberg, , Germany

Darlington, , United Kingdom

Roma, , Italy

Göttingen, , Germany

Bern, , Switzerland

Mainz, , Germany

Edegem, , Belgium

Ghent, , Belgium

Chemnitz, , Germany

Portsmouth, , United Kingdom

Milano, , Italy

Tarragona, , Spain

Catania, , Italy

Trier, , Germany

Madrid, , Spain

Aalst, , Belgium

Lecce, , Italy

Manchester, , United Kingdom

Graz, , Austria

Berlin, , Germany

Málaga, , Spain

Feldkirch, , Austria

Roma, , Italy

Valencia, , Spain

Granada, , Spain

Cordoba, , Spain

Alcorcón, , Spain

Greifswald, , Germany

Roma, , Italy

Sesto San Giovanni, , Italy

Terni, , Italy

Liestal, , Switzerland

Köln, , Germany

Murcia, , Spain

Burgos, , Spain

Almelo, , Netherlands

Barakaldo, , Spain

Edegem, Antwerpen, Belgium

Prescot, , United Kingdom

Northeim, , Germany

Haarlem, , Netherlands

Trento, , Italy

Ravenna, , Italy

Liège, , Belgium

Madrid, , Spain

Rostock, , Germany

Lugo, , Spain

Bath, , United Kingdom

Logroño, , Spain

Novara, , Italy

Hasselt, , Belgium

Genève, , Switzerland

Bergamo, , Italy

Piacenza, , Italy

Torquay, , United Kingdom

Roma, , Italy

Firenze, , Italy

Prato, , Italy

Genova, , Italy

Siegen, , Germany

Ulm, , Germany

Legnago, , Italy

Rivoli, , Italy

Napoli, , Italy

Amersfoort, , Netherlands

Bad Segeberg, , Germany

Heidelberg, , Germany

Ludwigshafen, , Germany

Pirna, , Germany

Acquaviva Delle Fonti, , Italy

Alcoi, , Spain

L'hospitalet De Llobregat, , Spain

Roeselare, , Belgium

Arnhem, , Netherlands

Durham, , United Kingdom

Milano, , Italy

Maastricht, , Netherlands

Zwolle, , Netherlands

Castellón De La Plana, , Spain

Cáceres, , Spain

Las Palmas De Gran Canaria, , Spain

Hagen, , Germany

Kassel, , Germany

Telford, , United Kingdom

Modena, , Italy

Watford, , United Kingdom

Donostia, , Spain

Santiago De Compostela, , Spain

Dresden, , Germany

Ehringshausen, , Germany

Torrette, , Italy

Nocera Inferiore, , Italy

Southampton, , United Kingdom

Barcelona, , Spain

Linz, , Austria

Sankt Aegyd Am Neuwalde, , Austria

Wien, , Austria

Aachen, , Germany

Aachen, , Germany

Bad Homburg, , Germany

Bechhofen, , Germany

Berlin, , Germany

Bruchsal, , Germany

Chemnitz, , Germany

Dessau, , Germany

Detmold, , Germany

Dortmund, , Germany

Dresden, , Germany

Elsterwerda, , Germany

Görlitz, , Germany

Haßloch, , Germany

Konstanz, , Germany

Leipzig, , Germany

Lohne, , Germany

Ludwigsburg, , Germany

Riesa, , Germany

Strausberg, , Germany

Trier, , Germany

A Coruña, , Spain

Aue, , Germany

Bad Elster, , Germany

Bad Krozingen, , Germany

Bamberg, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Biedenkopf, , Germany

Blankenhain, , Germany

Bonn, , Germany

Bunde, , Germany

Burg, , Germany

Chemnitz, , Germany

Dresden, , Germany

Duisburg, , Germany

Düren, , Germany

Eisenach, , Germany

Erlangen, , Germany

Essen, , Germany

Flensburg, , Germany

Flensburg, , Germany

Fulda, , Germany

Gera, , Germany

Gräfenhainichen, , Germany

Hainburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hannover, , Germany

Heiligenstadt, , Germany

Ingolstadt, , Germany

Kaiserslautern, , Germany

Katzhütte, , Germany

Kiel, , Germany

Koblenz, , Germany

Kornwestheim, , Germany

Kyritz, , Germany

Köln, , Germany

Köln, , Germany

Leipzig, , Germany

Lichtenfels, , Germany

Luebeck, , Germany

Lutherstadt Wittenberg, , Germany

Magdeburg, , Germany

Mainz, , Germany

Mannheim, , Germany

Mannheim, , Germany

Meiningen, , Germany

Moers, , Germany

Mühldorf, , Germany

Mühldorf, , Germany

Mülheim An Der Ruhr, , Germany

München, , Germany

München, , Germany

Münster, , Germany

Münster, , Germany

Münster, , Germany

Neu Isenburg, , Germany

Oer Erkenschwick, , Germany

Papenburg, , Germany

Papenburg, , Germany

Passau, , Germany

Potsdam, , Germany

Potsdam, , Germany

Radebeul, , Germany

Schwerin, , Germany

Schwäbisch Hall, , Germany

Singen, , Germany

Sonneberg, , Germany

Straubing, , Germany

Straubing, , Germany

Unterwellenborn, , Germany

Völklingen, , Germany

Weinheim, , Germany

Wermsdorf, , Germany

Weyhe, , Germany

Wolmirstedt, , Germany

Wuppertal, , Germany

Zwiesel, , Germany

Thun, , Switzerland

Bilbao, , Spain

Pamplona, , Spain

Madrid, , Spain

Craigavon, , United Kingdom

Alicante, , Spain

Toledo, , Spain

Hardenberg, , Netherlands

Dornbirn, , Austria

Graz, , Austria

Gribomont, , Austria

Horsching, , Austria

Klagenfurt Am Worthersee, , Austria

Linz, , Austria

Mattersburg, , Austria

Melk, , Austria

Salzburg, , Austria

Sankt Stefan Ob Stainz, , Austria

Wien, , Austria

Wien, , Austria

Wien, , Austria

Wien, , Austria

Wien, , Austria

Dendermonde, , Belgium

Genk, , Belgium

Gilly, , Belgium

Ieper, , Belgium

Ronse, , Belgium

Tielt, , Belgium

Yvoir, , Belgium

Belfast, , United Kingdom

Cardiff, , United Kingdom

Darlington, , United Kingdom

Dartford, , United Kingdom

Hampshire, , United Kingdom

Leicester, , United Kingdom

London, , United Kingdom

London, , United Kingdom

London, , United Kingdom

London, , United Kingdom

Middlesbrough, , United Kingdom

Plymouth, , United Kingdom

Salford, , United Kingdom

Staffordshire, , United Kingdom

Trowbridge, , United Kingdom

Wales, , United Kingdom

Wansford, , United Kingdom

Watford, , United Kingdom

Pavia, , Italy

Rieti, , Italy

Boussu, , Belgium

Brasschaat, , Belgium

Bruxelles, , Belgium

Bruxelles, , Belgium

Bruxelles, , Belgium

Bruxelles, , Belgium

Bruxelles, , Belgium

Bruxelles, , Belgium

Ciney, , Belgium

Ghent, , Belgium

Gribomont, , Belgium

Haine Saint Paul, , Belgium

Halen, , Belgium

Huy, , Belgium

Kortrijk, , Belgium

La Louvière, , Belgium

Liège, , Belgium

Lodelinsart, , Belgium

Mons, , Belgium

Oostende, , Belgium

Sint Truiden, , Belgium

Tienen, , Belgium

Agrigento, , Italy

Ancona, , Italy

Anzio, , Italy

Ariccia, , Italy

Ascoli Piceno, , Italy

Augusta, , Italy

Avellino, , Italy

Avezzano, , Italy

Bari, , Italy

Bari, , Italy

Bari, , Italy

Bari, , Italy

Benevento, , Italy

Bentivoglio, , Italy

Bologna, , Italy

Bologna, , Italy

Bolzano, , Italy

Bolzano, , Italy

Cagliari, , Italy

Casale Monferrato, , Italy

Caserta, , Italy

Castelfranco Veneto, , Italy

Catania, , Italy

Catanzaro, , Italy

Cava Dè Tirreni, , Italy

Chieti, , Italy

Ciriè, , Italy

Cona, , Italy

Coppito, , Italy

Cremona, , Italy

Firenze, , Italy

Firenze, , Italy

Firenze, , Italy

Foggia, , Italy

Formia, , Italy

Frosinone, , Italy

Genova, , Italy

La Spezia, , Italy

Lamezia Terme, , Italy

Matera, , Italy

Melfi, , Italy

Messina, , Italy

Mestre, , Italy

Milano, , Italy

Milano, , Italy

Milano, , Italy

Milano, , Italy

Milano, , Italy

Mirano, , Italy

Modena, , Italy

Napoli, , Italy

Napoli, , Italy

Napoli, , Italy

Napoli, , Italy

Novi Ligure, , Italy

Padova, , Italy

Palermo, , Italy

Palermo, , Italy

Perugia, , Italy

Perugia, , Italy

Pisa, , Italy

Portogruaro, , Italy

Potenza, , Italy

Ragusa, , Italy

Rho, , Italy

Rimini, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Salerno, , Italy

Saronno, , Italy

Sarzana, , Italy

Sassari, , Italy

Siena, , Italy

Siena, , Italy

Taranto, , Italy

Torino, , Italy

Treviso, , Italy

Urbino, , Italy

Varese, , Italy

Verbania, , Italy

Breda, , Netherlands

Lachen, , Switzerland

Madrid, , Spain

León, , Spain

Wien, , Austria

Amberg, , Germany

Bad Friedrichshall, , Germany

Bad Homburg, , Germany

Bad Homburg, , Germany

Baiersbronn, , Germany

Berlin, , Germany

Bremerhaven, , Germany

Bünde, , Germany

Dresden, , Germany

Fulda, , Germany

Gifhorn, , Germany

Hannover, , Germany

Potsdam, , Germany

Radebeul, , Germany

Seehausen, , Germany

Ursensollen, , Germany

Witten, , Germany

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Dordrecht, , Netherlands

Ede, , Netherlands

Hilversum, , Netherlands

Hoogeveen, , Netherlands

Hoorn, , Netherlands

Leeuwarden, , Netherlands

Leiderdorp, , Netherlands

Rotterdam, , Netherlands

Tiel, , Netherlands

Bacelona, , Spain

Badajoz, , Spain

Badalona, Barcelona, , Spain

Barcelona, , Spain

Fuenlabrada Madrid, , Spain

Gijon, , Spain

Granada, , Spain

Huelva, , Spain

Jaén, , Spain

La Coruña, , Spain

Las Palmas De Gran Canaria, , Spain

Madrid, , Spain

Majadahonda Madrid, , Spain

Majdahonda Madrid, , Spain

Malaga, , Spain

Marbella Málaga, , Spain

Mendaro, , Spain

Murcia, , Spain

Palma De Mallorca, , Spain

Port De Sagunt, , Spain

Reus, , Spain

Sabadell, Barcelona, , Spain

Salamanca, , Spain

Salt, Girona, , Spain

Sant Joan Despi, Barcelona, , Spain

Sevilla, , Spain

Sevilla, , Spain

Soria, , Spain

Tarragona, , Spain

Terrassa Barcelona, , Spain

Valencia, , Spain

Valencia, , Spain

Valladolid, , Spain

Vigo Pontevedra, , Spain

Zaragoza, , Spain

Baden, , Switzerland

Davos, , Switzerland

Frauenfeld, , Switzerland

Lugano, , Switzerland

Lugano, , Switzerland

Olten, , Switzerland

Rennaz, , Switzerland

St.Gallen, , Switzerland

Yverdon Les Bains, , Switzerland

Zürich, , Switzerland

Kendal, , United Kingdom

Northumbria, , United Kingdom

Bouge, , Belgium

Gouda, , Netherlands

Winterswijk, , Netherlands

Asturias, , Spain

Asturias, , Spain

Asturias, , Spain

Asturias, , Spain

Binningen, , Switzerland

Almeria, , Spain

Coslada, Madrid, , Spain

Denia, , Spain

Patients applied

0 patients applied

Trial Officials

Global Clinical Leader

Study Director

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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