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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)
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

Azioni sul documento

pubblicato il 2020/01/20 11:44:00 GMT+1 ultima modifica 2020-02-03T13:55:40+01:00