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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.
The aim of the current study is to evaluate the effectiveness and safety of bempedoic acid combined with ezetimibe and either atorvastatin or rosuvastatin (hereafter defined as triple therapy) in a real-world clinical setting. No drug will be administered during this observational study.
The primary objective of the study is to evaluate the effectiveness of the triple therapy in terms of LDL-C reduction at 8 weeks.
The secondary objectives will include the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempedoic acid | Drug | No drug was administered in this observational study. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative LDL-C change between untreated and 8 week after triple therapy start | LDL-C will be assessed using a standard lipid panel blood test, | Baseline to 8 weeks after initiation of triple therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients at ESC/EAS 2019 dyslipidemia guideline goal at 8 weeks and 1 year | The 2019 EAS/ESC guidelines recommend treatment targets of at least a 50% reduction from baseline LDL-C levels and an LDL-C concentration below 1.8 mmol/L for patients at high and 1.4 mmol/l for patients at very high cardiovascular risk. | Baseline to 1 year after initiation of triple therapy |
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Key Inclusion Criteria:
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:
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
Key Exclusion Criteria:
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Prospective data from routine clinical practice will be collected over the course of 1 year involving approximately 2000 patients across approximately 200 sites in Europe (Germany, Italy, Spain, Austria, and Belgium) treated by both specialized and non-specialized physicians in hospital and office-based settings.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daiichi Sankyo Contact for Clinical Trial Information | Contact | 9089926400 | CTRinfo_us@daiichisankyo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innere Medizin | Recruiting | Braunau am Inn | 5280 | Austria |
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| Ezetimibe |
| Drug |
No drug was administered in this observational study. |
|
| Rosuvastatin | Drug | No drug was administered in this observational study. |
|
| Atorvastatin | Drug | No drug was administered in this observational study. |
|
| Relative LDL-C change between untreated and 1 year after triple therapy start | LDL-C will be assessed using a standard lipid panel blood test, | From any prior LMT exposure to 1 year after initiation of triple therapy |
| Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 8 weeks after triple therapy start | LDL-C will be assessed using a standard lipid panel blood test, | From pre-bempedoic acid/pre-FDC initiation to 8 weeks after initiation of triple therapy |
| Relative LDL-C change between pre-bempedoic acid/pre-FDC initiation and 1 year after triple therapy start | LDL-C will be assessed using a standard lipid panel blood test, | From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of triple therapy |
| Relative change in laboratory values between triple therapy start and 8 weeks and 1 year thereafter | Labs will be assessed using a standard panel blood test, | Baseline to 1 year after initiation of triple therapy |
| Patient and physician reported adherence at 8 weeks and 1 year after triple therapy start | Adherence will be judged by the physician/patient. | Baseline to 1 year after initiation of triple therapy |
| Incidence of adverse events under triple therapy exposure | Adverse events are defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Baseline to 1 year after initiation of triple therapy |
| Proportion of patients with MACE-3 and MACE-4 events | MACE-3 and MACE-4 events will consist of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only). | Baseline to 1 year after initiation of triple therapy |
| Innere Medizin 1 | Recruiting | Feldkirch | 6800 | Austria |
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| Uniklinik Graz, Endokrinologie und Diabetes | Recruiting | Graz | 8036 | Austria |
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| Uniklinik Graz, Kardiologie | Recruiting | Graz | 8036 | Austria |
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| Innere Medizin 3 - Kardiologie | Recruiting | Innsbruck | 6020 | Austria |
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| Klinikum Wels-Grieskirchen GmbH+B18 | Terminated | Kepler Universitätsklinikum Gmb+ | 4600 | Austria |
| Innere Medizin | Recruiting | Klagenfurt | 9020 | Austria |
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| Innere Medizin | Recruiting | Linz | 4020 | Austria |
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| Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin | Recruiting | Linz | 4021 | Austria |
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| Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr | Recruiting | Linz | 4040 | Austria |
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| Ordination | Recruiting | Mattersburg | 7210 | Austria |
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| Landesklinikum Mistelbach - Gänserndorf | Recruiting | Mistelbach | 2130 | Austria |
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| Ordination Dr. med. univ. Evelyn Fließer-Görzer | Recruiting | Saint Stefan Bei Graz | 8511 | Austria |
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| Praxis Gesundheitszentrum Moos 15 (Praxis Prof. Lichtenauer) | Recruiting | Salzburg | 5020 | Austria |
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| DOZ (Dialyse- und Ordinationszentrum) Privatklinik Wehrle-Diakonissen | Recruiting | Salzburg | 5026 | Austria |
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| Klinik Landstrasse, Kardiologie | Recruiting | Vienna | 1030 | Austria |
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| Ordination Univ.-Prof. Dr. Kurt Huber | Terminated | Vienna | 1060 | Austria |
| Zentrum für Klinische Studien Dr. Hanusch GmbH | Terminated | Vienna | 1060 | Austria |
| AKH Wien | Recruiting | Vienna | 1090 | Austria |
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| Meduni Wien, Endokrinologie und Diabetes | Recruiting | Vienna | 1090 | Austria |
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| Meduni Wien, Kardiologie | Recruiting | Vienna | 1090 | Austria |
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| Clinic Hietzing | Recruiting | Vienna | 1130 | Austria |
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| Herzzentrum 18 | Recruiting | Vienna | 1180 | Austria |
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| Karl Landsteiner Institut für kardiovaskuläre und intensivmedizinische Forschung c/o Abteilung für Kardiologie, Klinik Floridsdorf | Recruiting | Vienna | 1210 | Austria |
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| Azorg | Recruiting | Aalst | 9300 | Belgium |
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| UZA (Antwerp University Hospital) | Recruiting | Antwerp | 2650 | Belgium |
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| Epicure Hornu | Recruiting | Boussu | 7301 | Belgium |
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| A.Z. KLINA Brasschaat | Recruiting | Brasschaat | 2930 | Belgium |
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| Algemeen Ziekenhuis Sint-Jan Oostende | Recruiting | Bruges | 8400 | Belgium |
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| CHU Brugman | Recruiting | Brussels | 1020 | Belgium |
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| UZ Brussel | Recruiting | Brussels | 1090 | Belgium |
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| CHU Charleroi Hopital civil Marie-Curie | Recruiting | Charleroi | 6042 | Belgium |
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| GHDC Charleroi - Site Hôpital Saint-Joseph | Recruiting | Charleroi | 6060 | Belgium |
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| Z.O.L - Campus St. Jan | Recruiting | Genk | 3600 | Belgium |
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| Az Sint Lucas | Recruiting | Ghent | 9000 | Belgium |
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| UZ Gent | Active, not recruiting | Ghent | 9000 | Belgium |
| CHR Huy | Active, not recruiting | Huy | 4500 | Belgium |
| AZ Groeninge Kortrijk | Recruiting | Kortrijk | 8500 | Belgium |
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| Pôle hospitalier Jolimont | Recruiting | La Louvrière | 7100 | Belgium |
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| JAN YPERMAN Ziekenhuis | Recruiting | Leper | 8900 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| CHR Citadelle de Liège | Active, not recruiting | Liège | 4000 | Belgium |
| CHU Mons Ambroise Paré | Recruiting | Mons | 7000 | Belgium |
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| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
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| AZ Glorieux | Recruiting | Ronse | 9600 | Belgium |
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| CHU UCL Mont-Godinne | Recruiting | Yvoir | 5530 | Belgium |
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| Praxis für Kardiologie Aachen | Recruiting | Aachen | 52062 | Germany |
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| Klinikum Ahaus | Recruiting | Ahaus | 48683 | Germany |
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| Praxis W. Almohamed | Recruiting | Alsfed | 36304 | Germany |
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| Zentrum für klinische Studien Bad Homburg | Recruiting | Bad Homburg | 61348 | Germany |
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| Dialysezentrum Hellersdorf Mitte | Recruiting | Berlin | 12627 | Germany |
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| Lipidambulanz Charite Campus Virchow | Recruiting | Berlin | 13353 | Germany |
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| MEDICLIN Reha-Zentrum Spreewald | Recruiting | Burg | 03096 | Germany |
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| Kardiologische Gemeinschaftspraxis Flemmingstr. | Recruiting | Chemnitz | 09116 | Germany |
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| Klinik Detmold | Recruiting | Detmold | 32756 | Germany |
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| Praxis Dr. Methfessel | Recruiting | Dresden | 01159 | Germany |
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| Cardiologicum Dresden | Recruiting | Dresden | 01796 | Germany |
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| Herz- und Gefäßmedizin Goslar | Recruiting | Goslar | 38640 | Germany |
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| ndgl.; viele Kombinationstherapien | Terminated | Gräfenhainichen | 06773 | Germany |
| Praxis | Recruiting | Greiz | 07973 | Germany |
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| Kardiologie am Tibarg | Recruiting | Hamburg | 22459 | Germany |
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| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Germany |
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| HPK Heidelberger Praxisklinik | Recruiting | Heidelberg | 69115 | Germany |
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| Uni-Klinik Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| Kardiopraxis | Recruiting | Kaiserslautern | 67655 | Germany |
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| GK Mittelrhein | Recruiting | Koblenz | 56073 | Germany |
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| Klinikum Konstanz | Recruiting | Konstanz | 78464 | Germany |
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| Universitätsklinikum Leipzig | Recruiting | Leipzig | 04103 | Germany |
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| DRK Krankenhaus Lichtenstein Gemeinnützige GmbH | Recruiting | Lichtenstein | 09350 | Germany |
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| Cardio Centrum Ludwigsburg | Recruiting | Ludwigsburg | 71634 | Germany |
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| Kardiopraxis | Recruiting | Mainz | 55122 | Germany |
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| Kardiologische Praxis Markkleeberg | Recruiting | Markkleeberg | 04416 | Germany |
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| Kardiologie Gem. Praxis Dres Reiff/Linse/Haj-Yehia/Specking | Recruiting | Moers | 47441 | Germany |
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| Praxis Dr. Norbert Schön | Recruiting | Mühldorf A. Inn | 84453 | Germany |
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| Kardiologische Gemeinschaftpraxis Papenburg | Recruiting | Papenburg | 26871 | Germany |
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| Kardiologische Gemeinschaftspraxis Papenburg | Recruiting | Papenburg | 26871 | Germany |
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| Hausärztlich-kardiologisches MVZ,,Am Felsenkeller" GmbH | Recruiting | Pirna | 01796 | Germany |
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| Kardiologische Gemeinschaftspraxis am Park Sanssouci | Recruiting | Potsdam | 14469 | Germany |
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| Lipidambulanz Uniklinikum Regensburg | Recruiting | Regensburg | 93053 | Germany |
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| Parkkardiologie, kard. Gemeinschaftspraxis | Recruiting | Stanhsdorf B. Berlin | 14532 | Germany |
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| BBT Trier | Terminated | Trier | 54292 | Germany |
| Diabetologische Schwerpunktpraxis | Recruiting | Trier | 54292 | Germany |
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| Herzklinik | Recruiting | Ulm | 89077 | Germany |
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| Dialysezentrum Hofaue | Terminated | Wuppertal | 42103 | Germany |
| Ente Ecclesiastico "Miulli" | Recruiting | Acquaviva delle Fonti | 70021 | Italy |
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| INRCA | Recruiting | Ancona | 60127 | Italy |
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| AO Moscati | Recruiting | Avellino | 83100 | Italy |
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| Osp. "San Paolo" | Recruiting | Bari | 70123 | Italy |
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| Ospedale di Bolzano | Recruiting | Bolzano | 39100 | Italy |
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| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
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| Osp. santo spirito | Recruiting | Casale Monferrato | 15033 | Italy |
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| Ospedale Sant'Anna e san Sebastiano | Recruiting | Caserta | 81100 | Italy |
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| Policlinnico Mater Domini | Recruiting | Catanzaro | 88100 | Italy |
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| Osp. SS Annunziata | Recruiting | Chieti | 66100 | Italy |
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| PO Nuovo Umberti I | Recruiting | Enna | 94100 | Italy |
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| Osp. Sant'Anna di Cona | Recruiting | Ferrara | 44124 | Italy |
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| Policlinico "Riuniti" | Recruiting | Foggia | 71122 | Italy |
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| Policlinico San Martino | Recruiting | Genova | 16132 | Italy |
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| Osp della Misericordia | Recruiting | Grosseto | 58100 | Italy |
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| Osp. "Vito Fazzi" | Recruiting | Lecce | 73100 | Italy |
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| Ospedale Mater Salutis | Recruiting | Legnagno | 37045 | Italy |
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| Spedali Riuniti | Recruiting | Livorno | 57124 | Italy |
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| Ospedale di Mantova | Recruiting | Mantua | 46100 | Italy |
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| Policlinico G. Martino | Recruiting | Messina | 98124 | Italy |
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| IRCCS Monzino | Recruiting | Milan | 20138 | Italy |
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| IRCCS Galeazzi Sant'Ambrogio | Recruiting | Milan | 20157 | Italy |
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| Policlinico Modena | Recruiting | Modena | 41125 | Italy |
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| AO Cardarelli | Recruiting | Naples | 80131 | Italy |
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| Policlinico Federico II | Recruiting | Naples | 80131 | Italy |
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| AOU Vanvitelli, I Policlinico | Recruiting | Naples | 80138 | Italy |
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| Policlinico P. Giaccone | Recruiting | Palermo | 90127 | Italy |
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| ICS Maugeri | Recruiting | Pavi | 27100 | Italy |
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| S. Maria della Misericordia | Recruiting | Perugia | 06129 | Italy |
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| Presidio Ospedaliero | Recruiting | Pescara | 65124 | Italy |
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| Ospedale PederzoliItlit | Recruiting | Peschiera | 37019 | Italy |
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| Cisanello | Recruiting | Pisa | 56124 | Italy |
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| Osp. Santa Maria delle Croci | Recruiting | Ravenna | 48121 | Italy |
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| Osp infermi di rivoli | Recruiting | Rivoli | 10098 | Italy |
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| Policlinico Tor Vergata | Recruiting | Roma | 00133 | Italy |
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| Ospedale Pertini | Recruiting | Roma | 00157 | Italy |
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| Ospedale Sant'Andrea | Recruiting | Roma | 00189 | Italy |
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| Policlinico Umberto I | Recruiting | Rome | 00161 | Italy |
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| Molinette Università to | Recruiting | Torino | 10126 | Italy |
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| Ospedale Mauriziano | Recruiting | Torino | 10128 | Italy |
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| Osp. di Cattinara | Recruiting | Trieste | 34149 | Italy |
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| Ospedale di Portogruaro | Recruiting | Venezia | 30026 | Italy |
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| AOUI Verona | Recruiting | Verona | 37126 | Italy |
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| H. Univers. De Albacete | Recruiting | Albacete | 02006 | Spain |
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| Hospital General Universitario Dr. Balmis | Recruiting | Alicante | 03010 | Spain |
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| H. General de Elche | Recruiting | Alicante | 03203 | Spain |
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| Hospital Universitario de San Juan | Recruiting | Alicante | 03550 | Spain |
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| Hospital Universitario de Cruces | Recruiting | Barakaldo | 48903 | Spain |
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| Hospital Universitario de Burgos | Recruiting | Burgos | 09006 | Spain |
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| H. Univ. Puerta del Mar | Recruiting | Cadiz | 11009 | Spain |
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| H. Punta de Europa | Recruiting | Cadiz | 11207 | Spain |
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| Hospital Universitario Puerto Real | Recruiting | Cadiz | 11510 | Spain |
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| Sierrallana Hospital | Recruiting | Cantabria | 39300 | Spain |
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| H. Univ. Reina Sofía | Active, not recruiting | Córdoba | 14004 | Spain |
| Hospital Universitario de Donostia | Recruiting | Donostia / San Sebastian | 20014 | Spain |
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| H. Univ. De Cabueñes | Recruiting | Gijón | 33394 | Spain |
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| H. Virgen de las Nieves | Recruiting | Granada | 18014 | Spain |
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| H. Juan Ramón Jiménez | Recruiting | Huelva | 21005 | Spain |
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| Hospital Universitario Médico-Quirúrgico de Jaén | Recruiting | Jaén | 23007 | Spain |
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| Hospital Universitario de Gran Canarias Dr. Negrín | Recruiting | Las Palmas de GC | 35010 | Spain |
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| Hospital de León | Recruiting | León | 24008 | Spain |
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| Hospital San Pedro | Recruiting | Logroño | 26006 | Spain |
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| H. Costa del Sol | Recruiting | Marbella (Málaga) | 29603 | Spain |
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| H. Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
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| Hospital Serranía de Ronda | Recruiting | Málaga | 29400 | Spain |
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| Hospital General Universitario Reina Sofía | Recruiting | Murcia | 30003 | Spain |
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| H. Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
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| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
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| Hospital Universitario Son LLatzer | Recruiting | Palma de Mallorca | 07198 | Spain |
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| Clínica Universidad de Navarra | Recruiting | Pamplona | 31008 | Spain |
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| Hospital Universitario de Navarra | Recruiting | Pamplona | 31008 | Spain |
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| Hospital Universitario de Canarias | Recruiting | Santa Cruz de Tenerife | 38320 | Spain |
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| Hospital de Segovia | Recruiting | Segovia | 40002 | Spain |
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| Hospital General Universitario de Toledo | Active, not recruiting | Toledo | 45007 | Spain |
| H. Clínico Univ. De Valencia | Recruiting | Valencia | 46010 | Spain |
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| Consorcio Hospital General Univ de Valencia | Recruiting | Valencia | 46014 | Spain |
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| Hospital La Fe | Recruiting | Valencia | 46026 | Spain |
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| Hospital Universitario de Álava | Recruiting | Vitoria-Gasteiz | 01009 | Spain |
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| Hospital Clinico Universitaro Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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