Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

Status: Recruiting
Location: See all (99) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent to participate

• At least 18 years of age

• High and very high risk patients as assessed by the physician suffering from documented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment

• Patients treated with:

‣ bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,

⁃ bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,

⁃ bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe

⁃ initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatin simultaneously

∙ 6\) Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.

∙ 8\) No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy \> 1 -year

Locations
Other Locations
Austria
Innere Medizin
RECRUITING
Braunau Am Inn
Innere Medizin 1
ACTIVE_NOT_RECRUITING
Feldkirch
Klinikum Wels-Grieskirchen GmbH+B18
ACTIVE_NOT_RECRUITING
Kepler Universitätsklinikum Gmb+
Innere Medizin
ACTIVE_NOT_RECRUITING
Klagenfurt
Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
RECRUITING
Linz
Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
ACTIVE_NOT_RECRUITING
Linz
Ordination
RECRUITING
Mattersburg
Ordination Dr. med. univ. Evelyn Fließer-Görzer
RECRUITING
Saint Stefan Bei Graz
DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen
RECRUITING
Salzburg
Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer)
RECRUITING
Salzburg
AKH Wien
ACTIVE_NOT_RECRUITING
Vienna
Clinic Hietzing
ACTIVE_NOT_RECRUITING
Vienna
Herzzentrum 18
RECRUITING
Vienna
Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf
ACTIVE_NOT_RECRUITING
Vienna
Meduni Wien, Kardiologie
ACTIVE_NOT_RECRUITING
Vienna
Ordination Univ.-Prof. Dr. Kurt Huber
ACTIVE_NOT_RECRUITING
Vienna
Zentrum für Klinische Studien Dr. Hanusch GmbH
ACTIVE_NOT_RECRUITING
Vienna
Belgium
Azorg
RECRUITING
Aalst
A.Z. KLINA Brasschaat
ACTIVE_NOT_RECRUITING
Brasschaat
Algemeen Ziekenhuis Sint-Jan Oostende
RECRUITING
Bruges
Z.O.L - Campus St. Jan
RECRUITING
Genk
AZ Groeninge Kortrijk
ACTIVE_NOT_RECRUITING
Kortrijk
JAN YPERMAN Ziekenhuis
ACTIVE_NOT_RECRUITING
Leper
AZ Delta
RECRUITING
Roeselare
AZ Glorieux
RECRUITING
Ronse
Germany
Praxis für Kardiologie Aachen
RECRUITING
Aachen
Klinikum Ahaus
ACTIVE_NOT_RECRUITING
Ahaus
Zentrum für klinische Studien Bad Homburg
RECRUITING
Bad Homburg
MEDICLIN Reha-Zentrum Spreewald
RECRUITING
Burg
Kardiologische Gemeinschaftspraxis Flemmingstr.
RECRUITING
Chemnitz
Cardiologicum Dresden
RECRUITING
Dresden
Praxis Dr. Methfessel
RECRUITING
Dresden
Herz- und Gefäßmedizin Goslar
ACTIVE_NOT_RECRUITING
Goslar
ndgl.; viele Kombinationstherapien
ACTIVE_NOT_RECRUITING
Gräfenhainichen
Praxis
RECRUITING
Greiz
Kardiologie am Tibarg
ACTIVE_NOT_RECRUITING
Hamburg
Kardiopraxis
RECRUITING
Kaiserslautern
GK Mittelrhein
ACTIVE_NOT_RECRUITING
Koblenz
Klinikum Konstanz
RECRUITING
Konstanz
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Cardio Centrum Ludwigsburg
RECRUITING
Ludwigsburg
Kardiologische Praxis Markkleeberg
RECRUITING
Markkleeberg
Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking
RECRUITING
Moers
Praxis Dr. Norbert Schön
RECRUITING
Mühldorf A. Inn
Kardiologische Gemeinschaftpraxis Papenburg
RECRUITING
Papenburg
Kardiologische Gemeinschaftspraxis Papenburg
RECRUITING
Papenburg
Hausärztlich-kardiologisches MVZ,,Am Felsenkeller GmbH
RECRUITING
Pirna
Kardiologische Gemeinschaftspraxis am Park Sanssouci
RECRUITING
Potsdam
Parkkardiologie, kard. Gemeinschaftspraxis
ACTIVE_NOT_RECRUITING
Stanhsdorf B. Berlin
Diabetologische Schwerpunktpraxis
RECRUITING
Trier
Herzklinik
RECRUITING
Ulm
Dialysezentrum Hofaue
ACTIVE_NOT_RECRUITING
Wuppertal
Italy
INRCA
RECRUITING
Ancona
Osp. San Paolo
RECRUITING
Bari
Ospedale di Bolzano
RECRUITING
Bolzano
Spedali Civili di Brescia
ACTIVE_NOT_RECRUITING
Brescia
Ospedale Sant'Anna e san Sebastiano
RECRUITING
Caserta
Osp. SS Annunziata
RECRUITING
Chieti
Osp. Sant'Anna di Cona
ACTIVE_NOT_RECRUITING
Ferrara
Policlinico Riuniti
ACTIVE_NOT_RECRUITING
Foggia
Policlinico San Martino
ACTIVE_NOT_RECRUITING
Genova
Ospedale di Mantova
RECRUITING
Mantova
IRCCS Galeazzi Sant'Ambrogio
ACTIVE_NOT_RECRUITING
Milan
Policlinico Federico II
RECRUITING
Napoli
Policlinico P. Giaccone
RECRUITING
Palermo
Ospedale PederzoliItlit
ACTIVE_NOT_RECRUITING
Peschiera
Osp infermi di rivoli
ACTIVE_NOT_RECRUITING
Rivoli
Ospedale Sant'Andrea
RECRUITING
Roma
Policlinico Umberto I
RECRUITING
Rome
Ospedale Mauriziano
ACTIVE_NOT_RECRUITING
Torino
Osp. di Cattinara
ACTIVE_NOT_RECRUITING
Trieste
Spain
H. Univers. De Albacete
ACTIVE_NOT_RECRUITING
Albacete
H. General de Elche
RECRUITING
Alicante
Hospital General Universitario Dr. Balmis
ACTIVE_NOT_RECRUITING
Alicante
Hospital Universitario de San Juan
ACTIVE_NOT_RECRUITING
Alicante
Hospital Universitario de Burgos
ACTIVE_NOT_RECRUITING
Burgos
H. Punta de Europa
RECRUITING
Cadiz
H. Univ. Puerta del Mar
ACTIVE_NOT_RECRUITING
Cadiz
Hospital Universitario Puerto Real
ACTIVE_NOT_RECRUITING
Cadiz
Sierrallana Hospital
ACTIVE_NOT_RECRUITING
Cantabria
H. Univ. Reina Sofía
ACTIVE_NOT_RECRUITING
Córdoba
H. Univ. De Cabueñes
ACTIVE_NOT_RECRUITING
Gijón
H. Virgen de las Nieves
RECRUITING
Granada
H. Juan Ramón Jiménez
ACTIVE_NOT_RECRUITING
Huelva
Hospital Universitario Médico-Quirúrgico de Jaén
ACTIVE_NOT_RECRUITING
Jaén
Hospital Universitario de Gran Canarias Dr. Negrín
ACTIVE_NOT_RECRUITING
Las Palmas De Gc
Hospital de León
RECRUITING
León
H. Virgen de la Victoria
ACTIVE_NOT_RECRUITING
Málaga
Hospital Serranía de Ronda
RECRUITING
Málaga
H. Costa del Sol
RECRUITING
Marbella (málaga)
H. Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Clínica Universidad de Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario de Canarias
ACTIVE_NOT_RECRUITING
Santa Cruz De Tenerife
Hospital de Segovia
RECRUITING
Segovia
Hospital La Fe
ACTIVE_NOT_RECRUITING
Valencia
Hospital Universitario de Álava
RECRUITING
Vitoria-gasteiz
Hospital Clinico Universitaro Lozano Blesa
ACTIVE_NOT_RECRUITING
Zaragoza
Contact Information
Primary
Daiichi Sankyo Contact for Clinical Trial Information
CTRinfo_us@daiichisankyo.com
9089926400
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 2000
Treatments
Triple therapy
Adult patients who have been diagnosed with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia treated with bempedoic acid in combination with ezetimibe and either rosuvastatin or atorvastatin (ie, triple therapy) and will be followed for up to 1 year after initiation of triple therapy.~A direct comparison between rosuvastatin and atorvastatin is not planned, only an assessment of triple therapy on LDL-C change in patients with primary hypercholesterolaemia.
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

This content was sourced from clinicaltrials.gov

Similar Clinical Trials