Informazioni sulle sperimentazioni dei farmaci
| Titolo/oggetto del contratto di sperimentazione | Coice EUDRACT | Promotore | Codice del protocollo del promotore | Data del nulla osta della Direzione | Data sottoscrizione del contratto | Unità operativa/e coinvolta/e | Nome - cognome del principal investigator |
CV del principal investigator
(link)
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Budget economico della sperimentazione | Rimborsi per prestazioni sanitarie aggiuntive legate alla sperimentazione | Totale (A+B) | Data chiusura della sperimentazione (per quelle chiuse) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction | 2016-002299-28 | AMGEN | GALACTIC-HF (AMG 20110203) | 29/06/2017 | 18/10/2017 | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | € 7.015,00 | NO | € 7.015,00 | NOT APPLICABLE |
| A Multicenter, Randomized, Parallel Group, Double Blind, Active and Placebo Controlled Study of BAY 1753011, a Dual V1a/V2 Vasopressin Receptor Antagonist, in Patients with Congestive Heart Failure: AVANTI Study | 2018-004059-18 | Bayer S.p.A. | AVANTI (BAY1753011) | 19/06/2019 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | € 7.000 | NO | € 7.000 | NOT APPLICABLE |
| A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function | 2017-002530-23 | Bristol-Myers Squibb Research and Development | BMS-986231 | 06/06/2018 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | Euro 9470.00 | NO | Euro 9470.00 | NOT APPLICABLE |
| A Phase III, randomized, double-blind trial to evaluate efficacy and safety of once daily empaglifozin 10 mg compared to placebo, in patient whit chronin Heart Failure with reduce Ejection Fraction (HFrEF). | 2016-002280-34 | Boehringer Ingelheim | EMPEROR 1245.121 | 14/09/2017 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | 4.955,00 Euro | NO | 4.955,00 Euro | NOT APPLICABLE |
| Sperimentazione di fase III, randomizzata, in doppio cieco per valutare l’efficacia e la sicurezza di empagliflozin 10 mg una volta al giorno rispetto al placebo, in pazienti affetti da insufficienza cardiaca cronica con frazione di eiezione preservata (HFpEF). | 2016-002278-11 | Boehringer Ingelheim | EMPEROR 1245.110 | 27/06/2017 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | 4.955,00 Euro | NO | 4.955,00 Euro | NOT APPLICABLE |
| A multi-center, randomized, double-blind, active-controlled, parallel- group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in patients with left ventricular dysfunction following an acute myocardial infarction | 2016-002154-20 | Novartis | PARADISE - CLCZ696G2301 | 04/05/2017 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | 4270.00 euro | NO | 4270.00 euro | NOT APPLICABLE |
| Protocol CLCZ696D2301_A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction | 2013-001747-31 | Novartis | PARAGON - CLCZ696D2301 | 13/11/2014 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | € 6.400,00 | NO | € 6.400,00 | 20/08/2019 |
| A 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the effect of LCZ696 on NT-proBNP, symptoms, exercise function and safety compared to individualized medical management of comorbidities in patients with heart failure and preserved ejection fraction | 2016-003410-28 | Novartis | PARALLAX - CLCLZ696D2302 | 27/10/2017 | 06/02/2018 | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | 4750.00 euro | NO | 4750.00 euro | 10/01/2020 |
| Prospective Evaluation of cognitive function in heart failure: A Randomized double-blind Study in Patients with preserved Ejection fraction Cardiac failure Treated wIth Valsartan or Entresto | 2016-001254-17 | Novartis | PERSPECTIVE - CLCZ696B2320 | 16/02/2017 | 20/04/2017 | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | € 15.800,00 | NO | € 15.800,00 | NOT APPLICABLE |
| A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure | 2017-003510-16 | SANOFI | SOLOIST-WHF - EFC15156 | 06/02/2018 | / | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | € 8.500 | NO | € 8.500 | NOT APPLICABLE |
| A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction(HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) | 2016-000671-25 | Merck Sharp & Dohme Corp | VICTORIA - MK1242001 | 19/01/2017 | 20/02/2017 | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | Euro 6.283,00 | NO | Euro 6.283,00 | 18/12/2019 |
| A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF) | 2018-000298-65 | Bayer S.p.A. | VITALITY-HFpEF - BAY19334 | 08/06/2018 | 06/08/2019 | U.O. di CARDIOLOGIA | DOTT. ALESSANDRO FUCILI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=ea8da0d4-66ca-4f46-bf70-5972253e8cd1 | Euro 7.500,00 | NO | Euro 7.500,00 | NOT APPLICABLE |
| Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist-based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement. (EdoxabaN Treatment versus VKA in patients with AF undergoing PCI ( ENTRUST-AF PCI) | 2016-002683-14 | DAIICHI SANKYO EUROPE GmbH | DSE-EDO-01-15-EU | 13/04/2017 | 16/05/2017 | U.O. di CARDIOLOGIA | PROF. GIANLUCA CAMPO | http://docente.unife.it/cmpglc/curriculum | Euro 3.777,00 | NO | Euro 3.777,00 | 09/08/2019 |
| The efficAcy and safety of Trimetazidine in Patients with angina pectoris having been treated by percutaneous Coronary Intervention. (ATPCI study) | 2010-022134-89 | I.T.I.S Institut de Recherches Internationales Servier | CL3-06790-010 | 11/09/2014 | 23/10/2014 | U.O. di CARDIOLOGIA | DOTT. GABRIELE GUARDIGLI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=5219b306-b9b3-4cc9-b9b6-ec1ba7388dc2 | Euro 4.750,00 | NO | Euro 4.750,00 | NOT APPLICABLE |
| Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6) | 2015-003997-33 | Kompetenznetz Vorhofflimmern e.V. | NOAH-AFNET 6 | 17/12/2017 | 10/05/2018 | U.O. di CARDIOLOGIA | DOTT. MATTEO BERTINI | http://trasparenza.ospfe.it/PublicUtente.aspx?oid=29fc035b-98d4-4e98-9a39-9c8cdb8e0586 | Euro 1.790,00 | NO | Euro 1.790,00 | NOT APPLICABLE |
- (A) Tale somma è destinata ...
- (B) Tale somma è destinata all'Azienda sanitaria a titolo di rimborso dei costi sotenuti dall'Azienda per l'effettuazione di prestazioni richieste dalla sperimentazione in aggiunta rispetto alla pratica clinica del centro