title: A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

summary: Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

status: Enrolling by invitation

lead_sponsor: United Therapeutics

location_country:
Greece
Romania
Australia
Belgium
Denmark
Taiwan
Ukraine
Croatia
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"

location_facility: Hospital Clinic de Barcelona, C/ Villarroel, 170

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

location_facility: University of Cincinnati-Medical Science Building

location_facility: CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.

location_facility: VA Greater Los Angeles Healthcare System

location_facility: The Lady Davis Carmel Medical Center, 7 Michal st.

location_facility: Weill-Cornell-New York Presbyterian Hospital

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

location_facility: University of Iowa Hospitals and Clinics

location_facility: The Ohio State University Wexner Medical Center

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

location_facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

location_facility: Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

location_facility: NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Gachon University Hospital Gil Medical Center

location_facility: MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

location_facility: University Clinic for Pulmonary Diseases, Jordanovac 104

location_facility: Meir Medical Center, 59 Tshernichovski st.

location_facility: University General Hospital of Alexandroupolis

location_facility: Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

location_facility: Fuwai Hospital, Chinese Academy of Medical Sciences

location_facility: Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc

location_facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah

location_facility: "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

location_facility: CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne

location_facility: University Health Network-Toronto General Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E.

location_facility: Tel Aviv Sourasky Medical Center, 6 Weizmann St.

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

location_facility: CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

location_facility: SMBD Jewish General Hospital d/b/a Jewish General Hospital

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

location_facility: Premium Clinic Wrocław CM, Podwale 83/17

location_facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

location_facility: University of California Davis Medical Center

location_facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

location_facility: Royal Free London NHS Foundation Trust, Pond Street

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Washington University School of Medicine

location_facility: The Methodist Hospital Research Institute

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Medical College of Wisconsin/Froedtert Hospital

location_facility: Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

location_facility: Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

location_facility: Sentara Cardiovascular Research Institute

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

location_facility: AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

location_facility: SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

location_facility: Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: Unidad de Investigacion Clinica en Medicina, S.C.

location_facility: Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

location_facility: Clinical Center of Serbia, Koste Todorovica 8

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

location_facility: Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

location_facility: AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

location_facility: Xiangya Hospital Central South University

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

location_facility: University General Hospital Attikon, 1 Rimini Street

location_facility: Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5


title: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

acronym: ReSTORE

summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217. Review.

name: Department of Pharmacy, Oregon Health & Science University, Portland, OR 97239, USA

name: Department of Internal Medicine Division of Infectious Diseases & Department of Medical Microbiology & Immunology; University of California Davis Medical Center, Sacramento, CA 95817, USA

family: Ham

full_name: Young Yoon Ham

given: Young Yoon

sequence: first

family: Lewis

full_name: James S Lewis

given: James S

sequence: additional

suffix: II

family: Thompson

full_name: George R Thompson

given: George R

suffix: III

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Microbiology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Cidara Therapeutics Inc.

location_country:
Italy
Spain
Germany
France
Bulgaria
Greece
Israel
Thailand
Singapore
Belgium
Argentina
Australia
China
Turkey
United States
Korea, Republic of
Taiwan
Colombia

location_facility: Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants

location_facility: The Second Hospital of Anhui Medical University

location_facility: University of Mississippi Medical Center

location_facility: University Hospital Puerta de Hierro Majadahonda

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: University Polyclinic Hospital of Modena

location_facility: University of Pittsburgh Falk Medical Center

location_facility: University and Polytechnic Hospital La Fe

location_facility: University of Milano-Bicocca - San Gerardo Hospital

location_facility: Centre Hospitalier Victor Dupouy - Argenteuil

location_facility: ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department

location_facility: University Hospital Vall d'Hebron (HUVH)

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: Paris University Hospitals Center - Cochin Hospital

location_facility: University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hotel Dieu Hospital Nantes University Hospital Center

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery

location_facility: Tours University Hospital Center, Bretonneau Hospital

location_facility: Hospital del Mar, Department of Infectious Diseases

location_facility: General University Hospital Gregorio Maranon

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Huashan Hospital Affiliated Fudan University

location_facility: University Hospitals Leuven, Campus Gasthuisberg

location_facility: Alexander Fleming Specialized Medical Institute

location_facility: Marseille University Hospital Center - North Hospital

location_facility: University Hospital Germans Trias i Pujol

location_facility: Integrated University Hospital "Santa Maria della Misericordia" of Udine

location_facility: Johannes Gutenberg University Medical Center

location_facility: Multiprofile Hospital for Active Treatment Puls

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: University Polyclinic Foundation Agostino Gemelli - IRCCS

location_facility: Amiens Picardie University Hospital - South

location_facility: General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

location_facility: Integrated University Health Authority of Trieste

location_facility: General Hospital of Athens "Laikon", Infectious Diseases Unit

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: General Hospital of Tianjin Medical University

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)

acronym: Ri-CoDIFy 2

summary:
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin.

A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted.

The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

ReferenceCitation: Carlson TJ, Endres BT, Bassères E, Gonzales-Luna AJ, Garey KW. Ridinilazole for the treatment of Clostridioides difficile infection. Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26. Review.

name:
Department of Pharmacy Practice and Translational Research, University of Houston College of Pharmacy, Houston,
      TX, USA

family: Carlson

full_name: Travis J. Carlson

given: Travis J.

family: Endres

full_name: Bradley T. Endres

given: Bradley T.

family: Bassères

full_name: Eugénie Bassères

given: Eugénie

family: Gonzales-Luna

full_name: Anne J. Gonzales-Luna

given: Anne J.

family: Garey

full_name: Kevin W. Garey

given: Kevin W.

journal_name: Expert Opinion on Investigational Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ipd_sharing: No

lead_sponsor: Summit Therapeutics

location_country:
United States
Chile
Peru
Mexico
Spain
Germany
France
Czechia
Lithuania
Israel
Georgia
Romania
Belgium
Belarus
Estonia
Canada
Latvia

location_facility: Groupe Hospitalier Bretagne Sud Hopital du Scorff

location_facility: Vitebsk regional clinical infectious diseases hospital

location_facility: JSC"Infectious Diseases, Aids and Clinical Immunology Research Center"

location_facility: Meir Medical Center, Infection Diseases Unit

location_facility: Multi-Specialty Research Associates Inc.

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Klinikum St. Georg - Klinik für Infektiologie, Tropenmedizin, Nephrologie unfd Rheumatologie

location_facility: L&C Professional Medical Research Institute

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci

location_facility: Hospital Universitario Dr. José Eleuterio González

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Horizon Research Group of Opelousas, LLC

location_facility: Western Michigan University Homer Stryker M.D.

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: University Texas MD Anderson Cancer Center

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: CH Intercommunal de Cornouaille (CHIC) QUIMPER / MIIS

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

location_facility: City Clinical Hospital of Infectious Diseases

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: LTD "Acad. G. Chapidze Emergency Cardiology Center"

location_facility: Vidant Multispecialty Clinic - Kinston, Attn. Research Department

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie

location_facility: Infectious Diseases & Infection Control Unit

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hospital Nacional Alberto Sabogal Sologuren

location_facility: Fakultni nemocnice Brno, Klinika infekcnich chorob

location_facility: Washington University School of Medicine

location_facility: DiGiovanna Institute For Medical Education

location_facility: Wright State University and Premier Health Clinical Trials Research Alliance

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Unité de maladies infectieuses - RDJ Ouest - Hôpital Huriez

location_facility: Uni. Klinik Tübingen Innere Medizin I Hepatologische Therapie- und Studienambulanz

location_facility: Spitalul Clinic de Boli Infectioase Cluj-Napoca

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: University of Alberta, Division of Gastroenterology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Rambam Health Care Campus, Internal ward A

location_facility: LTD "Israeli-Georgian Medical research Clinic Helsicore"

location_facility: Institutul Regional de Gastroenterologie şi Hepatologie

location_facility: St. David's Healthcare Office of Research

location_facility: Vancouver Island Health Authority, Research and Capacity Building

location_facility: Grodno City Clinical Hospital of Emergency Care


title: GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

summary: The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Incyte Corporation

location_country:
Italy
Austria
United States
Sweden
Switzerland
Germany
Finland
France
Poland
Greece
Israel
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Chu de Grenoble - Hopital Albert Michallon

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitario Y Politcnico de La Fe

location_facility: King'S College Hospital (Nhs Foundation)

location_facility: St. George'S University Hospitals Nhs Foundation Trust

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CLINICA DI EMATOLOGIA, UNIVERSITï¿½ POLITECNICA DELLE MARCHE

location_facility: University Medical Centre Hamburg-Eppendorf Centre of Oncology

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University of Arizona Cancer Center - Out Pt.

location_facility: Universitaetsklinikum Erlangen - Medizinische Klinik 5

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Winship Cancer Institute of Emory University

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: CENTRE HOSPITALIER UNIVERSITAIRE DE LIï¿½GE - SART TILMAN

location_facility: Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia

location_facility: Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen

location_facility: Advocate Lutheran General Hospital - Oncology Specislists Sc

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: University of California San Diego Medical Center, Moores Cancer Center

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: University Hospital of West Attica - Attikon

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

location_facility: Nottingham University Hospitals Nhs Trust

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Augusta University - Medical College of Georgia

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: I.R.C.C.S. Casa Sollievo Della Sofferenza

location_facility: University Hospitals Cleveland Medical Center

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"


title: A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas

summary: A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

ReferenceCitation: Philip PA, Buyse ME, Alistar AT, Rocha Lima CM, Luther S, Pardee TS, Van Cutsem E. A Phase III open-label trial to evaluate efficacy and safety of CPI-613 plus modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) in patients with metastatic adenocarcinoma of the pancreas. Future Oncol. 2019 Oct;15(28):3189-3196. doi: 10.2217/fon-2019-0209. Epub 2019 Sep 12.

name: Karmanos Cancer Institute, Wayne State University, Department of Oncology, Detroit, MI 48331, USA

family: Philip

full_name: Philip A Philip

given: Philip A

name: International Drug Development Institute, Louvain-La-Neuve, Belgium

family: Buyse

full_name: Marc E Buyse

given: Marc E

name: Morristown Medical Center of Atlantic Health System, Morristown, NJ 07152, USA

family: Alistar

full_name: Angela T Alistar

given: Angela T

name: Wake Forest Baptist Comprehensive Cancer Center of Wake Forest University, Department of Oncology, Winston Salem, NC 27157, USA

family: Lima

full_name: Caio MSPR Lima

given: Caio MSPR

name: Rafael Pharmaceuticals, Cranbury, NJ 08512, USA

family: Luther

full_name: Sanjeev Luther

given: Sanjeev

family: Pardee

full_name: Timothy S Pardee

given: Timothy S

name: University Hospitals & KU Leuven, Department of Digestive Oncology, Leuven, Belgium

family: Cutsem

full_name: Eric Van Cutsem

given: Eric Van

journal_name: Future Oncology

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

ipd_sharing: Undecided

lead_sponsor: Rafael Pharmaceuticals Inc.

location_country:
United States
France
Israel
Belgium
Germany
Korea, Republic of

location_facility: Kyungpook National University Chilgok Hospital

location_facility: L'ICM, Institut régional du Cancer de Montpellier

location_facility: University of Cincinnati Cancer Institute

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: The University of Kansas Cancer Center - Clinical Research Center - Fairway Office Park

location_facility: University Hospitals - Seidman Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: University of Pittsburgh-Hillman cancer ceter

location_facility: Gustave Roussy Cancer Campus Grand Paris (Institut de Cancerologie Gustave-Roussy)

location_facility: Seoul National University Bundang Hospital

location_facility: Severance Hospital - Yonsei Cancer Center

location_facility: The Chaim Sheba Medical Center - Sheba Cancer Research Center (SCRC)

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Northwestern Memorial Hospital - Arkes Family Pavilion

location_facility: New York University Langone Medical Center

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

location_facility: Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center-Henry-Joyce Cancer Clinic

location_facility: The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

summary:
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Corbus Pharmaceuticals Inc.

location_country:
Greece
Romania
Belgium
Russian Federation
France
Poland
Slovakia
Canada
Sweden
Netherlands
Bulgaria
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Spain

location_facility: Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant

location_facility: Medial Center for Ambulatory Diagnosis and Treatment

location_facility: University of Arkansas for Medical Sciences

location_facility: University Hospital and UW Health Clinics

location_facility: Children's faculty hospital with polyclinic Banska Bystrica

location_facility: Centro Regionale Toscano di Riferimento per la Fibrosi Cistica

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis

location_facility: Institute for Child and Youth Health Care of Vojvodina

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Dartmouth-Hitchcock Manchester (satellite site)

location_facility: Clinical for Pulmonary Diseases, Clinical Center of Serbia

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation

location_facility: Unidad de Fibrosis Quistica y Transplante Pulmonar

location_facility: Wolfson Cystic Fibrosis Centre City Hospital Campus

location_facility: Institute for Mother and Child, Department of CF for Children's and Youth

location_facility: Klinikum der Ludwig Maximilian Universität München

location_facility: Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis

location_facility: Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy

location_facility: Milton S. Hershey Medical Center / Penn State College of Medicine

location_facility: Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology

location_facility: University Medicine Essen Ruhrlandklinik

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow

location_facility: Pediatric Pulmonology, Törökbálint, Hungary

location_facility: Azienda Ospedaliera Universitaria Verona

location_facility: Catholic Hospital Bochum - St. Josef-Hospital

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: Service de Pediatrie Medico-Chirurgicale et Genetique

location_facility: First St. Petersburg State Pavlov Medical University

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: Cardiff and Vale University Health Board

location_facility: Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged

location_facility: Dartmouth-Hitchcock Medical Center (main location)

location_facility: Scientfic Research Institute of Pulmonology

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: Centre de Recherche en Explorations Fonctionnelles (CREF)

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: University of Debrecen - Kenezy Gyula University Hospital

location_facility: Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc

intervention_type: Other

status_simplified: Completed


type: EudraCT Number

title: A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

ReferenceCitation: Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.

name: Department of Radiology Feinberg School of Medicine Northwestern University Evanston IL USA

family: Salem

full_name: Riad Salem

given: Riad

name: Department of Medical Oncology City of Hope Comprehensive Cancer Center and Beckman Research Institute Duarte CA USA

family: Li

full_name: Daneng Li

given: Daneng

name: Genentech, Inc South San Francisco CA USA

family: Sommer

full_name: Nicolas Sommer

given: Nicolas

family: Hernandez

full_name: Sairy Hernandez

given: Sairy

family: Verret

full_name: Wendy Verret

given: Wendy

family: Ding

full_name: Beiying Ding

given: Beiying

name: Department of Radiology University of Pisa School of Medicine Pisa Italy

family: Lencioni

full_name: Riccardo Lencioni

given: Riccardo

journal_name: Cancer Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

evidence: oa repository (via OAI-PMH title and last author match)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.

family: Galle

full_name: Peter R Galle

given: Peter R

family: Finn

full_name: Richard S Finn

given: Richard S

family: Qin

full_name: Shukui Qin

given: Shukui

family: Ikeda

full_name: Masafumi Ikeda

given: Masafumi

family: Zhu

full_name: Andrew X Zhu

given: Andrew X

family: Kim

full_name: Tae-You Kim

given: Tae-You

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Breder

full_name: Valeriy Breder

given: Valeriy

family: Merle

full_name: Philippe Merle

given: Philippe

family: Kaseb

ReferenceCitation: Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.

name: Department of Medical Oncology, Cancer Center West China Hospital Sichuan University Chengdu China

name: West China Biostatistics and Cost‐Benefit Analysis Center Sichuan University Chengdu China

name: Department of Clinical Pharmacy West China Hospital Sichuan University Chengdu China

title: Atezolizumab and bevacizumab combination compared with sorafenib as the first‐line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost‐effectiveness analysis in China and the United states

ReferenceCitation: Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

name: From the Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles (R.S.F.), the City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte (D.L.), and Genentech, South San Francisco (W.V., S.H., Y.W.) — all in California; the People’s Liberation Army Cancer Center, Jinling Hospital, Nanjing (S.Q.), and Roche Product Development (D.-Z.X., J.L., C.H.) and Jiahui International Cancer Center, Jiahui Health (A.X.Z.), Shanghai — all in China; National Cancer...

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
United States
Hong Kong
Spain
Germany
France
Czechia
Japan
Poland
Singapore
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Centre hospitalier de l'Universite de Montreal (CHUM)

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"; Clinical Biotechnologies

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

location_facility: Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

location_facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: McGill University Health Centre - Glen Site

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hopital Timone Adultes; Gastro Enterologie

location_facility: The 900th Hospital of PLA joint service support force

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Hôpital d'Adultes; Service hépato-gastro-entérologie

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

location_facility: SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY

location_facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: General Hospital of Jinan Military Command of PLA

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

location_facility: Med. Hochschule Hannover; Gastroenterologie

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: University of California Irvine Medical Center

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie

location_facility: Harbin Medical University Cancer Hospital

location_facility: Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Uni of California - San Diego; Cancer Center & Dept of Medicine

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: M.D Anderson Cancer Center; Uni of Texas At Houston

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio de Oncologia Medica

location_facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Institut Gustave Roussy; Gastro-Enterologie

location_facility: Hopital Charles Nicolle; Gastroenterologie

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Veterans General Hospital; Cancer Center


ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

family: King

full_name: Brett King

given: Brett

family: Maari

full_name: Catherine Maari

given: Catherine

family: Lain

full_name: Edward Lain

given: Edward

family: Silverberg

full_name: Jonathan I. Silverberg

given: Jonathan I.

family: Issa

full_name: Maher Issa

given: Maher

family: Holzwarth

full_name: Katrin Holzwarth

given: Katrin

family: Brinker

full_name: Dennis Brinker

given: Dennis

family: Cardillo

full_name: Tracy Cardillo

given: Tracy

family: Nunes

full_name: Fabio P. Nunes

given: Fabio P.

family: Simpson

full_name: Eric L. Simpson

given: Eric L.

journal_name: American Journal of Clinical Dermatology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
Brazil
Switzerland
Netherlands
Finland
France
Japan
Poland
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility: Hospital da Clinicas da Faculdade de Medicina da USP

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Queen's Square Dermatology and Allergology

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: Fondazione IRCCS Osp.Maggiore Policlinico - Dermatologia

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd

location_facility: CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Universitätsklinikum Hamburg - Eppendorf

ipd_sharing: Yes

type: Other Identifier

source: euctr

title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

summary: The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.


title: A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)

summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Zhang P, Gumuscu B, Swaby RF, Hughes BGM. Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629). J Clin Oncol. 2020 Sep 1;38(25):2916-2925. doi: 10.1200/JCO.19.03054. Epub 2020 Jul 16.

name: Aix-Marseille University, Marseille, France

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

name: Centro Estatal de Cancerologiade Chihuahua, Chihuahua, Mexico

family: Gonzalez

full_name: Rene Gonzalez

given: Rene

family: Basset-Seguin

full_name: Nicole Basset-Seguin

given: Nicole

name: Rambam Health Care Campus, Haifa, Israel

family: Vornicova

full_name: Olga Vornicova

given: Olga

name: Chaim Sheba Medical Center at Tel HaShomer, Ramat Gan, Israel

family: Schachter

full_name: Jacob Schachter

given: Jacob

name: Townsville University Hospital, Townsville, QLD, Australia

family: Joshi

full_name: Abhishek Joshi

given: Abhishek

name: Institut Universitaire du Cancer and CHU de Toulouse, Toulouse, France

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

name: Centre Hospitalier Universitaire de Reims–Hôpital Robert Debre, Reims, France

family: Grange

full_name: Florent Grange

given: Florent

name: Hospital Duran i Reinals L’Institut Català d'Oncologia de Hospitalet, Idibell, Oncobell, Ciberonc, Barcelona, Spain

family: Piulats

full_name: Josep M. Piulats

given: Josep M.

name: Fox Chase Cancer Center, Philadelphia, PA

family: Bauman

full_name: Jessica R. Bauman

given: Jessica R.

family: Zhang

full_name: Pingye Zhang

given: Pingye

family: Gumuscu

full_name: Burak Gumuscu

given: Burak

family: Swaby

full_name: Ramona F. Swaby

given: Ramona F.

name: Royal Brisbane and Women’s Hospital, Herston, QLD, Australia

name: University of Queensland, Brisbane, QLD, Australia

family: Hughes

full_name: Brett G. M. Hughes

given: Brett G. M.

journal_name: Journal of Clinical Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hughes BGM, Mendoza RG, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Chirovsky D, Zhang P, Gumuscu B, Swaby RF, Grob JJ. Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629. Dermatol Ther (Heidelb). 2021 Oct;11(5):1777-1790. doi: 10.1007/s13555-021-00598-6. Epub 2021 Sep 23.

family: Mendoza

full_name: Rene Gonzalez Mendoza

given: Rene Gonzalez

location_country:
United States
Mexico
Germany
France
Israel
Norway
Australia
Spain
Canada
United Kingdom

location_facility: Lombardi Comprehensive Cancer Center ( Site 0360)

location_facility: University College Hospital NHS Foundation Trust ( Site 0801)

location_facility: Royal Brisbane and Women s Hospital ( Site 0407)

location_facility: CHU Reims - Hopital Robert Debre ( Site 0610)

location_facility: Universitaetsklinikum Essen ( Site 0650)

location_facility: Universitaetsklinikum Mannheim GmbH ( Site 0654)

location_facility: Medizinische Hochschule Hannover ( Site 0652)

location_facility: Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0800)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 0804)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0308)

location_facility: Stanford University Medical Center ( Site 0366)

location_facility: University of Kansas Cancer Center ( Site 0361)

location_facility: Hospital General de Valencia ( Site 0752)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0901)

location_facility: Princess Alexandra Hospital ( Site 0405)

location_facility: Southern Medical Day Care Centre ( Site 0408)

location_facility: The Ottawa Hospital Cancer Centre ( Site 0101)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)

location_facility: Moores UC San Diego Cancer Center ( Site 0352)

location_facility: Haukeland Universitetssykehus ( Site 0902)

location_facility: Institut Gustave Roussy (IGR) ( Site 0602)

location_facility: Sunnybrook Research Institute ( Site 0105)

location_facility: Massachusetts General Hospital ( Site 0362)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0364)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 0600)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0753)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0356)

location_facility: Hospital Duran i Reinals ICO de Hospitalet ( Site 0751)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8001)

location_facility: Princess Margaret Cancer Centre ( Site 0102)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 0754)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0605)

location_facility: Universitaets-Hautklinik Kiel ( Site 0656)

location_facility: St. Joseph Heritage Healthcare ( Site 0350)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)

location_facility: Dr. Leon Richard Oncology Centre ( Site 0100)

location_facility: Universitatsklinikum Tübingen ( Site 0651)


title: A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.

location_country:
Italy
Brazil
United States
Chile
Spain
Germany
France
Japan
Norway
Hungary
Australia
Ireland
New Zealand
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.

location_facility: UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: University of Tennessee Erlanger Oncology & Hematology

location_facility: Severance Hospital Yonsei University Health System

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden

location_facility: Chang Gung Med Foundation. Kaohsiung Branch

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: Universitaetsklinikum Magdeburg. Klinik fuer Urologie

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov

location_facility: Kingston Health Sciences Centre - KGH Site

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Saitama Medical University International Medical Center

location_facility: MI Precarpathian Clinical Oncology Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ankara Numune Education and Research Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: National Medical Research Radiology Centre

location_facility: Central Clinical Hospital with outpatient Clinic

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Centro Avancado de Tratamento Oncologico - CENANTRON -

location_facility: Instituto do Cancer de Sao Paulo - ICESP

location_facility: Istanbul Medeniyet Universitesi Goztepe EAH

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan

location_facility: Hopital Prive Toulon Hyeres Sainte Marguerite

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Pontificia Universidad Catolica de Chile

location_facility: RMI Sumy Regional Clinical Oncology Dispensary

location_facility: Sunnybrook Health Sciences, Odette Cancer Centre

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Universitetssykehuset i Nord Norge. Kreftavdelingen

location_facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec


title: A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

summary:
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene [ESR1] Y537S mutation).

lead_sponsor: H3 Biomedicine Inc.

location_country:
United States
United Kingdom
France

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Institut de Cancérologie Strasbourg Europe


title: An International, Multicentre, Prospective, Non-interventional Observational Registry for Patients With X-Linked Hypophosphatemia (XLH)

acronym: XLH Registry

summary: This is an international, multicentre, prospective, non-interventional, observational Registry of patients with X-Linked hypophosphatemia (XLH). The main objective of this XLH Registry is to collect data to characterise the treatment, progression and long-term outcomes of XLH in both adult and paediatric settings.

study_type: Observational

time_perspective: Other

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Italy
Sweden
Switzerland
Netherlands
Spain
United Kingdom
France
Czechia
Bulgaria
Israel
Slovakia
Norway
Hungary
Belgium
Ireland
Slovenia
Portugal
Denmark
Germany
Latvia

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: NHS Greater Glasgow & Clyde - South Glasgow University Hosp Division

location_facility: Århus Universitetshospital - Aarhus sygehus

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: Presidio Ospedaliero Di Summa Antonio Perrino

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Complejo Hospitalario Universitario Insular Materno-Infantil

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Istituto Auxologico Italiano -I.R.C.C.S.

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Presidio Sant'Anna)

location_facility: Hospital Universitario Central de Asturias

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital Dona Estefânia

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Royal Belfast Hospital for Sick Children

location_facility: National Institute of Childrenś Health NUDCH

location_facility: Great Ormond Street Hospital for Children

location_facility: Hospital General Universitario Santa Lucía

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: "Hopital Pierre-Paul Riquet Centre de Rhumatologie"

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Oslo Universitetssykehus HF, Aker Sykehus


title: A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide

acronym: OCEAN

summary: This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients with RRMM following 2-4 lines of prior therapy and who are refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients will receive either melflufen+dex or pomalidomide+dex.

lead_sponsor: Oncopeptides AB

location_country:
Greece
Romania
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Lithuania
Norway
Korea, Republic of
Netherlands
Hungary
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Estonia


ReferenceCitation: Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

name: Department of Internal Medicine and Cardiology, Charité University Medicine, Campus Virchow Klinikum, Berlin, Germany

name: Department of Internal Medicine and Cardiology, German Heart Center, Berlin, Germany

name: German Center for Cardiovascular Research (DZHK), Partner Site Berlin, Berlin, Germany

name: Berlin Institute of Health (BIH), Berlin, Germany

family: Pieske

full_name: Burkert Pieske

given: Burkert

name: Clinic and Policlinic for Cardiology, University Hospital Leipzig, Clinic for Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany

name: German Center for Cardiovascular Research (DZHK), partner site Göttingen, Göttingen, Germany

family: Wachter

full_name: Rolf Wachter

given: Rolf

name: Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois

name: Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine, Chicago, Illinois

family: Shah

full_name: Sanjiv J. Shah

given: Sanjiv J.

family: Baldridge

full_name: Abigail Baldridge

given: Abigail

name: Now with Vifor Pharma Management Ltd, Glattbrugg, Switzerland

family: Szeczoedy

full_name: Peter Szeczoedy

given: Peter

name: Novartis Pharmaceuticals, East Hanover, New Jersey

family: Ibram

full_name: Ghionul Ibram

given: Ghionul

family: Shi

full_name: Victor Shi

given: Victor

family: Zhao

full_name: Ziqiang Zhao

given: Ziqiang

name: Royal Brompton Hospital, London, United Kingdom

name: School of Cardiovascular Medicine & Sciences, Faculty of Life Sciences & Medicine, King’s College London, London, United Kingdom

family: Cowie

full_name: Martin R. Cowie

given: Martin R.

name: for the PARALLAX Investigators and Committee members

family: Prado

full_name: Aldo Carlos Prado

given: Aldo Carlos

family: Wenetz

full_name: Liza Maria Marcela Wenetz

given: Liza Maria Marcela

family: Brasca

full_name: Daniela Garcia Brasca

given: Daniela Garcia

family: Albisu

full_name: Juan Pablo Albisu

given: Juan Pablo

family: Fernandez

full_name: Alberto Alfredo Fernandez

given: Alberto Alfredo

family: Liberman

full_name: Alberto Liberman

given: Alberto

family: Echeverria

full_name: Graciela Echeverria

given: Graciela

family: Bartolacci

full_name: Ines Bartolacci

given: Ines

family: Ranz

full_name: Maria Ranz

given: Maria

family: Pedrotti

full_name: Mercela Pedrotti

given: Mercela

family: Tapia

full_name: Daniela Tapia

given: Daniela

family: Robertson

full_name: Marina Robertson

given: Marina

family: Exposito

full_name: Solana Exposito

given: Solana

family: Barrionuevo

full_name: Marcelo Barrionuevo

given: Marcelo

family: Resk

full_name: Jorge Hector Resk

given: Jorge Hector

family: Mercau

full_name: Guillermo Mercau

given: Guillermo

full_name: Maria Christiane Valeria Braga Braile Sternieri

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Peru
Guatemala
Romania
Belgium
Russian Federation
Denmark
India
France
Thailand
Lithuania
Slovakia
Argentina
Canada
Turkey
Colombia
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Estonia
Latvia

title: A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

summary: The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).


ReferenceCitation: Verma S, Dhingra NK, Butler J, Anker SD, Ferreira JP, Filippatos G, Januzzi JL, Lam CSP, Sattar N, Peil B, Nordaby M, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Reduced trial committees and investigators. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial. Lancet Diabetes Endocrinol. 2021 Nov 30. pii: S2213-8587(21)00292-8. doi: 10.1016/S2213-8587(21)00292-8. [Epub ahead of print]

ReferenceCitation: Böhm M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Mahfoud F, Brueckmann M, Jamal W, Ofstad AP, Schüler E, Ponikowski P, Wanner C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol. 2021 Sep 28;78(13):1337-1348. doi: 10.1016/j.jacc.2021.07.049.

family: Böhm

full_name: Michael Böhm

given: Michael

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Butler

full_name: Javed Butler

given: Javed

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Ferreira

full_name: João Pedro Ferreira

given: João Pedro

family: Pocock

full_name: Stuart J. Pocock

given: Stuart J.

family: Mahfoud

full_name: Felix Mahfoud

given: Felix

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Jamal

full_name: Waheed Jamal

given: Waheed

family: Ofstad

full_name: Anne Pernille Ofstad

given: Anne Pernille

family: Schüler

full_name: Elke Schüler

given: Elke

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Wanner

full_name: Christoph Wanner

given: Christoph

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Packer

full_name: Milton Packer

given: Milton

journal_name: Journal of the American College of Cardiology

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

version: acceptedVersion

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046.

family: Januzzi

full_name: James L. Januzzi

given: James L.

suffix: Jr.

title: Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial

ReferenceCitation: Packer M, Butler J, Zannad F, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Schnaidt S, Zeller C, Schnee JM, Anker SD. Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial. Circulation. 2021 Oct 19;144(16):1284-1294. doi: 10.1161/CIRCULATIONAHA.121.056824. Epub 2021 Aug 29.

name: Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas TX USA and Imperial College, London UK

name: Department of Medicine, University of Mississippi School of Medicine, Jackson, MS

name: Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France

name: Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France; Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal

name: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London UK

name: Washington DC Veterans Affairs Medical Center, Washington DC

name: Department of Cardiology, University of Minnesota, Minneapolis, MN

name: Theresienkrankenhaus and St.Hedwig-Klinik, Mannheim, Germany

name: Department of Cardiology, Hospital Saint Joseph, Paris, France

name: Department of Cardiology, University Hospital, Rigshospitalet, Copenhagen, Denmark

name: Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, CA

name: Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

name: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories:
HAL
PubMed Central
researchonline.lshtm.ac.uk

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Effect of Empagliflozin on Worsening Heart Failure Events in Patients with Heart Failure and a Preserved Ejection Fraction: The EMPEROR-Preserved Trial

ReferenceCitation: Pocock SJ, Ferreira JP, Gregson J, Anker SD, Butler J, Filippatos G, Gollop ND, Iwata T, Brueckmann M, Januzzi JL, Voors AA, Zannad F, Packer M. Novel biomarker-driven prognostic models to predict morbidity and mortality in chronic heart failure: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4455-4464. doi: 10.1093/eurheartj/ehab579.

name: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK

name: Université de Lorraine, Inserm, Centre d'Investigations Cliniques Plurithématique 1433, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France

name: Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany

name: Department of Medicine, University of Mississippi, Jackson

name: Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

name: Boehringer Ingelheim International GmbH, Ingelheim, Germany

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

name: Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany

name: Massachusetts General Hospital, Boston, MA, USA

name: Baim Institute for Clinical Research, Boston, MA, USA

name: University of Groningen, Groningen, The Netherlands

name: Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA

ReferenceCitation: Lam CSP, Ferreira JP, Pfarr E, Sim D, Tsutsui H, Anker SD, Butler J, Filippatos G, Pocock SJ, Sattar N, Verma S, Brueckmann M, Schnee J, Cotton D, Zannad F, Packer M. Regional and ethnic influences on the response to empagliflozin in patients with heart failure and a reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4442-4451. doi: 10.1093/eurheartj/ehab360.

name: National Heart Centre Singapore, Duke-NUS Medical School, 5 Hospital Drive, Singapore169609, Singapore

name: Department of Cardiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands

name: Université de Lorraine, INSERM, Centre d'Investigation Clinique et Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), 4 Rue du Morvan, 54500 Vandoeuvre les Nancy, France

name: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany

name: Kyushu University, 744 Motooka Nishi-ku Fukuoka 819-0395, Japan

name: Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, D-13353 Berlin, Germany

name: Department of Medicine, University of Mississippi School of Medicine, 2500 North State Street, Jackson, MS 39216, USA

name: Heart Failure Unit, National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Rimini 1, Chaidari 124 62, Athens, Greece

name: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel St, London WC1E 7HT, UK

name: Institute of Cardiovascular and Medical Sciences, University of Glasgow, RC214 Level C2, Institute of C&MS, Bhf Gcrc, Glasgow G12 8TA, UK

name: St. Michael's Hospital and University of Toronto, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada

name: Faculty of Medicine Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, D-68167 Mannheim, Germany

name: Boehringer Ingelheim Pharmaceuticals Inc, 900 Ridgebury Road Ridgefield, CT 06877

name: Baylor University Medical Center, 3500 Gaston Ave, Dallas, TX 75246, USA

name: Imperial College, Exhibition Rd, South Kensington, London SW7 2BX, UK

ReferenceCitation: Ferreira JP, Zannad F, Pocock SJ, Anker SD, Butler J, Filippatos G, Brueckmann M, Jamal W, Steubl D, Schueler E, Packer M. Interplay of Mineralocorticoid Receptor Antagonists and Empagliflozin in Heart Failure: EMPEROR-Reduced. J Am Coll Cardiol. 2021 Mar 23;77(11):1397-1407. doi: 10.1016/j.jacc.2021.01.044.

title: Interplay of Mineralocorticoid Receptor Antagonists and Empagliflozin in Heart Failure

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Brueckmann M, Jamal W, Cotton D, Iwata T, Zannad F; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload: EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Mar 23;77(11):1381-1392. doi: 10.1016/j.jacc.2021.01.033.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

title: Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload

ReferenceCitation: Butler J, Anker SD, Filippatos G, Khan MS, Ferreira JP, Pocock SJ, Giannetti N, Januzzi JL, Piña IL, Lam CSP, Ponikowski P, Sattar N, Verma S, Brueckmann M, Jamal W, Vedin O, Peil B, Zeller C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Mar 31;42(13):1203-1212. doi: 10.1093/eurheartj/ehaa1007.

name: Department of Medicine, University of Mississippi School of Medicine, Jackson, MS, USA

name: Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Augustenburger Platz 1, D-13353 Berlin, Germany

name: Heart Failure Unit, National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, 2 Thivon Street, Athens 157 72, Greece

name: Department of Cardiothoracic Physiology and Surgery, Cardiovascular R&D Unit, Institut Lorrain du Coeur et des Vaisseaux, 5 Rue du Morvan, 54500 Vandeuvre-lès-Nancy, France

name: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel Street, London WCIE 7HT, UK

name: Division of Cardiology, McGill University Health Center, 1001 Decarie Blvd.Royal Victoria Hospital, D05.5115 Montreal, Quebec H4A 3J1, Canada

name: Cardiology Division, Harvard Medical School, Massachusetts General Hospital, 25 Shattuck St, Boston, MA 02115, USA

name: Department of Medicine, Wayne State and Central Michigan Universities, 540 E. Canfield Ave, Detroit, MI 48201, USA

name: National Heart Centre Singapore & Duke-National University of Singapore, 8 College Rd, Singapore 169857, Singapore

name: Centre for Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland

name: Institute of Cardiovascular and Medical Sciences, University of Glasgow, BHF Glasgow Cardiovascular Research Centre (GCRC), 126 University Place, Glasgow G12 8TA, UK

name: Division of Cardiac Surgery, St Michael’s Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada

name: Boehringer Ingelheim International GmbH, Binger Strasse 173 Ingelheim am Rhein, 55216, Germany

name: Faculty of Medicine Mannheim, University of Heidelberg, Ludolf-Krehl-Straße 13-17, 68167 Mannheim, Germany

name: Boehringer Ingelheim AB, Hammarby allé 29, 120 32 Stockholm, Sweden

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173 Ingelheim am Rhein, 55216, Germany

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riß, Germany

name: Cardiovascular Science, Baylor Heart and Vascular Institute, Baylor University Medical Center, 621 N. Hall Street, Dallas, TX 75226, USA

name: Faculty of Medicine, National Heart and Lung Institute, Imperial College, Guy Scadding Building, Cale Street, SW3 6LY London, UK

name: the EMPEROR-Reduced Trial Committees and Investigators

ReferenceCitation: Anker SD, Butler J, Filippatos G, Khan MS, Marx N, Lam CSP, Schnaidt S, Ofstad AP, Brueckmann M, Jamal W, Bocchi EA, Ponikowski P, Perrone SV, Januzzi JL, Verma S, Böhm M, Ferreira JP, Pocock SJ, Zannad F, Packer M. Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):337-349. doi: 10.1161/CIRCULATIONAHA.120.051824. Epub 2020 Nov 11.

name: Department of Cardiology, Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Germany (S.D.A.).

name: Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B., M.S.K.).

name: National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Greece (G.F.).

name: Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Germany (N.M.).

name: National Heart Centre Singapore & Duke-National University of Singapore (C.S.P.L.).

name: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (S.S.).

name: Medical Department, Boehringer Ingelheim Norway KS, Asker, Norway (A.P.O.).

name: Boehringer Ingelheim International GmbH, Ingelheim, Germany (M.B., W.J.).

name: Faculty of Medicine Mannheim, University of Heidelberg, Germany (M.B.).

name: Klinik für Innere Medizin III, Saarland University, Homburg/Saar, Germany (M.B.).

name: Heart Institute of the University of Sao Paulo (InCor), Brazil (E.A.B.).

name: Wroclaw Medical University, Poland (P.P.).

name: Hospital de Alta Complejidad El Cruce “Nestor Kirchner,” Florencio Varela, Buenos Aires, Argentina (S.V.P.).

name: Harvard Medical School, Massachusetts General Hospital, Boston (J.L.J.).

name: Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Canada (S.V.).

name: Institut Lorrain du Coeur et des Vaisseaux, Nancy, France (J.P.F., F.Z.).

name: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, UK (S.J.P.).

name: Baylor University Medical Center, Dallas, TX (M.P.).

name: On behalf of the EMPEROR-Reduced Trial Committees and Investigators

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Zannad F, Ferreira JP, Pocock SJ, Zeller C, Anker SD, Butler J, Filippatos G, Hauske SJ, Brueckmann M, Pfarr E, Schnee J, Wanner C, Packer M. Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights From EMPEROR-Reduced. Circulation. 2021 Jan 26;143(4):310-321. doi: 10.1161/CIRCULATIONAHA.120.051685. Epub 2020 Oct 23. Erratum in: Circulation. 2021 Jan 26;143(4):e29.

name: Université de Lorraine, INSERM, Centre d’Investigations Cliniques Plurithématique 1433, INSERM 1116, CHRU de Nancy, FCRIN INI-CRCT, Nancy, France (F.Z., J.P.F.).

name: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK (S.J.P.).

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany (C.Z.)

name: Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany (S.D.A.).

name: Department of Medicine, University of Mississippi School of Medicine, Jackson, MS. (J.B.).

name: National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece (G.F.).

name: Boehringer Ingelheim International GmbH, Ingelheim, Germany (S.J.H., M.B.).

name: Vth Department of Medicine, University Medical Center Mannheim (S.J.H.), University of Heidelberg, Mannheim, Germany.

name: Faculty of Medicine Mannheim (M.B.), University of Heidelberg, Mannheim, Germany.

name: Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J.S.).

name: Division of Nephrology, University Hospital, Würzburg, Germany (J.S.).

name: Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas TX (M.P.).

title: Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Brueckmann M, Jamal W, Zeller C, Schnaidt S, Zannad F. Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):326-336. doi: 10.1161/CIRCULATIONAHA.120.051783. Epub 2020 Oct 21. Erratum in: Circulation. 2021 Jan 26;143(4):e30.

name: Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).

name: Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany (S.D.A., W.D.).

name: Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.).

name: Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France (J.P.F., F.Z.).

name: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, UK (S.J.P.).

name: Washington DC Veterans Affairs Medical Center (P.C.).

name: Department of Cardiology, University of Minnesota, Minneapolis (I.A.).

name: Theresienkrankenhaus and St.Hedwig-Klinik, Mannheim, Germany (M.H.).

name: Department of Cardiology, Hospital Saint Joseph, Paris, France (M.K.).

name: University of Florida, Jacksonville (A.M.).

name: Department of Cardiology, University Hospital, Rigshospitalet, Copenhagen, Denmark (S.P.).

name: Section of Cardiology, San Francisco Veterans Affairs Medical Center, CA (J.R.T.).

name: School of Medicine, University of California, San Diego (J.R.T.).

name: Boehringer Ingelheim International GmbH, Ingelheim, Germany (M.B., W.J., C.Z.).

name: Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany (D.M., S.S.).

name: For the EMPEROR-Reduced Trial Committees and Investigators

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Böhm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.

name: From Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas (M.P.); Imperial College (M.P.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.J.P.), London, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (N.S.), and the Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Biomedical Research Centre, Glenfield Hospital, Leicester (I.S.) — all in the United...

title: Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

ReferenceCitation: Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678. Review.

name: Division of CardiologySaint Luke's Mid America Heart Institute Kansas City Missouri

name: Department of MedicineUniversity of Missouri‐Kansas City School of Medicine Kansas City Missouri USA

name: The George Institute for Global Health Sydney Australia

title: Effects of sodium glucose cotransporter type 2 inhibitors on heart failure

location_country:
Italy
Brazil
India
Mexico
Netherlands
Germany
Spain
France
Czechia
Japan
Korea, Republic of
Poland
Hungary
Belgium
Argentina
Australia
China
United States
United Kingdom
Canada

location_facility: Johns Hopkins University Hospital School of Medicine

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Dr. Nagy Laszlo Kardiologiai Maganrendeles

location_facility: INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

location_facility: 2nd Xiangya Hospital of Central South University

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Cardresearch Cardiologia Assistencial e de Pesquisas Ltda

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: CEPIC - Centro Paulista de Investigacao Clinica

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Novant Health Heart and Vascular Institute

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: IPECC - Instituto de Pesquisa Clínica de Campinas

location_facility: Doctor Jivraj Mehta Smarak Health Foundation

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: Affiliated Hospital of Jiangsu University

location_facility: CEMEDIC - Centro de Especialidades Medicas

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Corporacion Medica de Gral. San Martin S.A.

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno

location_facility: Shengjing Hospital of China Medical University

location_facility: The Affiliated Hospital of Southwest Medical University

location_facility: Curnew Medicine Professional Corporation

location_facility: The First Affiliated Hospital of Lanzhou University

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Instituto Cardiovascular de Monclova, S de RL de CV

location_facility: General Hospital of Shenyang Military Region

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Cardiovascular Research Center of South Florida

location_facility: Centro de Investigaciones Clínicas del Litoral

location_facility: Batra Hospital and Medical Research Centre

location_facility: Diseño y Planeación en Investigación Médica SC

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: FGM - Clínica Paulista de Doenças Cardiovasculares

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Leszek Bryniarski Specialized Medical Cabinet

location_facility: Fejer County Saint George University Teaching Hospital

location_facility: Poradnia Kardiologiczna Jaroslaw Jurowiecki

location_facility: Irmandade da Santa Casa de Misericórdia de Curitiba

location_facility: Mohan Babapulle Medicine Professional Medicine

location_facility: Jacksonville Center for Clinical Research

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: The First Afiliated Hospital, Sun Yet-sen University

location_facility: Nemocnice ve Frydku-Mistku, prispevkova organizace

location_facility: The University of North Carolina at Chapel Hill

location_facility: Asklepios Klinik Langen-Seligenstadt GmbH

location_facility: Hospital Universitário Pedro Ernesto UERJ

location_facility: Hospital Italiano Regional del Sur, Bahia Blanca

location_facility: Cardiovascular Institute and Fu Wai Hospital

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: North York Diagnostic and Cardiac Centre

location_facility: First Affiliated Hospital of Xi'an JiaoTong University

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Instituto de Investigaciones Clínicas de Quilmes

location_facility: Nanchang University Affiliated 3rd Hospital

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: Belgyogyaszati es Kardiologiai Maganrendelo

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: First Hospital Affiliated with Nanjing Medical University

location_facility: Fundacao Faculdade Regional de Medicina, Sao Jose

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Specialistic Cardiology&Hypertension Out-patient Clin,Kielce

location_facility: Cardiac Care and Vascular Medicine, PLLC

location_facility: Hospital Interzonal General de Agudos Dr Jose Penna

location_facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

location_facility: St. Francis Medical Group-Indiana Heart Physicians, Inc

location_facility: Hospital de Messejana Dr. Carlos Alberto Studart Gomes

location_facility: ICDF - Instituto de Cardiologia do Distrito Federal

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Guangzhou First Municipal People's Hospital

location_facility: The Second Affiliated Hospital of Lanzhou Medical University

location_facility: Krakow Specialistic Hospital of John Paul II

location_facility: Seoul National University Bundang Hospital

location_facility: Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice

location_facility: William Jennings Bryan Dorn VA Medical Center

location_facility: Centro de Investigacion Biomedica y Farmaceutica, S.C.

location_facility: Instituto Medico Fundación Grupo Colaborativo Rosario

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

location_facility: Specialist Hospital J. Dietla NZOZ Specialized Clinic "Gemini"

location_facility: Tianjin Union Medical Center Nankai University Affiliated Hospital

location_facility: Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

location_facility: Centro de Investigacion Cardiovascular y Metabolica

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Centro de Investigación Clinica Acelerada, S.C.

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Captain James A. Lovell Federal Health Care Center

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Ospedale della Val di Chiana Santa Margherita

location_facility: Centre de sante et de services sociaux de Beauce

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie West

location_facility: CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

location_facility: Centro Especializado em Cardiol Loema Instituto de Pesq Clin

location_facility: CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas

location_facility: The Provincial Polyclinical Hospital in Torun

location_facility: IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos - Universidade de Caxias do Sul

location_facility: MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil

location_facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

location_facility: Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud

location_facility: National Hospital Organization Hakodate Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: National Hospital Organization Kobe Medical Center

location_facility: University of North Texas Health Science Center

location_facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: Fukuokaken Saiseikai Futsukaichi Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

summary: The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.