type: Other Identifier

title: Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects.

summary: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL (2.6 mmol/L).

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Turkey
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
India
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: SBEI of HPE I. M. Sechenov First Moscow State Medical University, UKB #2

location_facility: Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat

location_facility: The 2nd Affiliated Hospital Of Harbin Medical University

location_facility: Divisione di Cardiologia con Utic ed Emodinamica - AOU Federico II di Napoli

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.

location_facility: "Prywatny Gabinet Kardiologiczny" Dr N.Med. Maciej Kosmider

location_facility: Hampton Roads Center for Clinical Research

location_facility: SBIH "City Clinical Hospital #81 Departments of Healthcare of Moscow"

location_facility: Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota

location_facility: Investigacion en Salud y Metabolismo S.C.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie, Ambulatoria

location_facility: Gemeinschaftspraxis Dres. Dirk Weber, Ulrich Weber, Heiner Saueressig, Birte Turner und Georg

location_facility: Cardiovascular Associates of the Southeast, LLC

location_facility: Irmandade da Santa Casa de Misericordia de Curitiba - Hospital Santa Casa de Misericordia

location_facility: DRK Kliniken Berlin Kopenick, Zentrum Klinische Forschung

location_facility: MHI "City Clinical Hospital #12" of the Healthcare Committee

location_facility: Ospedale S. Maria della Misericordia Dipartimento di Medicina, Medicina Interna,

location_facility: A.karahisar Kocatepe Universitesi Hastanesi Ahmet Necdet Sezer Uygulama ve Arastirma Hastanesi

location_facility: Pharmacology International Research, Inc.

location_facility: Instituto de Conhecimento, Ensino e Pesquisa (Administrative local)

location_facility: Nemocnice Pardubickeho kraje, a.s., Svitavska nemocnice

location_facility: Shri Krishna Hrudayalaya and Critical Care Centre

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Southern Health & Social Care Trust, Craigavon Area Hospital

location_facility: Consultorios Asociados de Endocrinologia e Investigacion Clinica Aplicada

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD"

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie, Oddzial Kardiologii

location_facility: Podlaski Osrodek Kardiologii Janusz Korecki

location_facility: Joondalup Cardiovascular Trials Foundation Inc.

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Women's & Family Care, LLC D.B.A GTC Research

location_facility: DIKa centrum s.r.o., Kardiologicka a interni ambulance

location_facility: Kardiologische Gemeinschaftspraxis Dres Med. Gerke/Buerger

location_facility: Spitalul Clinic Colentina, Departament Cardiologie

location_facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda.

location_facility: Federal State Budgetary Institution of Healthcare Hospital of Russian Academy of Sciences

location_facility: The Office of Maxine E. Hamilton, MD, PA

location_facility: Klinikum Fur Herz- & Kreislauferkrankungen

location_facility: Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED

location_facility: Green and Seidner Family Practice Associates

location_facility: Daejeon St. Mary's Hospital-The Catholic University of Korea

location_facility: Loema Medicina e Bem Estar- Centro Especializado em Cardiologia Ltda

location_facility: Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center

location_facility: Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS

location_facility: T. Joseph Raoof, Md, Inc/Encino Research Center

location_facility: Ben Yair Community Clinic - Clalit Health Services

location_facility: Metabolic and Atherosclerosis Research Center

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Federal state budget institution of healthcare Saint-Petersburg clinical hospital of Russian Academy

location_facility: Global Trial Research Center S.A. de C.V.

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Gdanskie Centrum Zdrowia, Poradnia Kardiologiczna

location_facility: Centrum Medyczne Zdrowa J. Trebacz, W. Zajdel Spolka jawna

location_facility: Spitalul Clinic Judetean De Urgenta Braila(Braila County Clincal Emergency Hospital)

location_facility: "Prof. Dr. N.C. Paulescu" National Institute of Diabetes, Nutrition and Metabolic Diseases,

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: Centrum Opieki Diabetologiczno-Endokrynologicznej i Ginekologiczno-Polozniczej

location_facility: County Emergency Hospital Satu Mare Diabetes, Nutrition And Metabolic Diseases Department

location_facility: Podoleanu G. Cristian-Gheorghe-Calin - Cardiology Medical Practice

location_facility: Hospital Parana - Parana Medical Research Center - MARIMED SERVICOS MEDICOS S.A.

location_facility: Atlanta Center for Clinical Research / Internal Medicine

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: (For IP storage only)The University of Texas Southwestern Medical Center

location_facility: MEDI M&M s.r.o., Ambulancia vnutorneho lekarstva

location_facility: Centro de Investigacion Medica Integral S.C.

location_facility: Hospital Universitario Ciencias Medicas / Fundacao Educacional Lucas Machado

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

location_facility: Medizinisches Versorgungszentrum am Bahnhof Spandau

location_facility: Intercoastal Medical Group (Drug Shipment Address and Administrative)

location_facility: Rothwell and Desborough Healthcare Group

location_facility: Retreat Cardiology LLC, dba Cardiology Associates of Richmond

location_facility: Ospedale Santa Maria della Misericordia Azienda ULSS 18 of Rovigo

location_facility: Mid-Cumberland Infectious Disease Consultants, PLC

location_facility: Daegu Catholic University Medical Center

location_facility: Abington Memorial Hospital (administrative only)

location_facility: Instituto de Terapeutica Experimental y Clinica (INTEC) Centro Universitario de Ciencias de la Salud

location_facility: CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo

location_facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02

location_facility: Synexus Manchester Clinical Research Centre-Manchester Science Park

location_facility: Cicemo - Consultorio de Investigaciones Clinicas E.M.O. S.R.L.

location_facility: Schwerpunktpraxis Dr. Luedemann fuer Diabetes Gefaess- und Ernaehrungsmedizin

location_facility: Consultorio Medico de Especialidad Dr. Demetrio Kosturakis Garcia

location_facility: Hospital Universitario Principe de Asturias

location_facility: BV Medical, s.r.o. Diabetologicka ambulancia,

location_facility: Howlands Clinic - Queen Elizabeth II Hospital

location_facility: State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital No. 10"

location_facility: Dr JM Engelbrecht Trial Site-Vergelegen Mediclinic

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: State Budgetary Educational Institution Of Higher Professional Education

location_facility: Division of Cardiology, Department of Medicine, Faculty of Medicine, Songklanagarind Hospital,

location_facility: Memorial Hospital: University of Colorado Health

location_facility: Universidade Federal do Para - Hospital Universitario Joao de Barros Barreto

location_facility: Przychodnia Specjalistyczna Samodzielny Publiczny ZOZ w Rudzie Slaskiej,

location_facility: Cranbrook Cardiology Research Associates

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: University of Arizona Medical Center South Campus

location_facility: CCBR Brasil - Centro de Pesquisa e Analises Clinicas LTDA

location_facility: GWT-TUD GmbH, Studienzentrum Professor Hanefeld

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Hospital Lomas de San Luis Intemacional (Emergencies)

location_facility: SC Centrul Medical Policlinico Di Monza SRL, Cardiologie

location_facility: Investigacion en Salud y Metabolismo S.C

location_facility: Centrul Medical Dr. Negrisanu SRL, Diabet Zaharat, Nutritie si Boli Metabolice

location_facility: Division of Cardiology, Department of medicine,Faculty of Medicine, Srinagarind Hospital, Khon Kaen

location_facility: Admin & Storage only:Northwest Heart Center

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: Uijeongbu St. Mary's Hospital-The Catholic University of Korea

location_facility: Cedir S.A - Centro De Diagnostico Y Rehabilitacion S.A.

location_facility: NZOZ PRZYCHODNIA SPECJALISTYCZNA Andrzej Wittek Henryk Rudzki s.c.

location_facility: Cardiovascular Research Institute of Dallas

location_facility: South Texas Cardiovascular Consultants, PLLC

location_facility: Altamira Family Medicine And Research Institute

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare "City Hospital #23"

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o., sp.k.

location_facility: Lahoja Asociacion para la Investigacion y Farmacovigilancia S.C.

location_facility: Synexus Watermeyer Clinical Research Centre

location_facility: CPClin- Centro de Pesquisas Clinicas Ltda./Clinica Dr. Freddy Goldberg Eliaschewitz

location_facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

location_facility: Instituto Cardiovascular De Buenos Aires

location_facility: Royal Bolton Hospital - Bolton Nhs Foundation Trust

location_facility: HBA S/A ASSISTENCIA MEDICA E HOSPITALAR-Hospital da Bahia

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: HMC (Haaglanden Medisch Centrum) Bronovo

location_facility: Heart Center, Songklanagarind Prince of Songkla University

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed

location_facility: Federal State Budgetary Institution "State Research Center for Preventive Medicine" of the Ministry

location_facility: Jacksonville Center for Clinical Research

location_facility: Aabenraa Hospital Hjertemedicinsk klinik Kredslobscentret, SHS

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Division of Cardiology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol

location_facility: Buffalo Medical Group - Research Department

location_facility: Dr. Pop Calin Florin - Cabinet Cardiologie

location_facility: Florida Hospital Cardiovascular Institute

location_facility: Instituto Jaqueline Scholz Issa e Mario Issa de Cardiologia LTDA

location_facility: State Budgetary Healthcare Institution "Region Clinical Hospital #3"

location_facility: Arizona Endocrine and Rheumatology Associates

location_facility: Clinical Research Advantage, Inc. (Administrative Mailing Only)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital General Universitario de Valencia

location_facility: MUDr. Antonin Dufka, kardiologicka ambulance

location_facility: INTERCARD Sp. z. o. o. Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Nowym Targu

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Universitaetsklinikum des Saarlandes Klinik fuer Innere Medizin III

location_facility: "OSTEO-MEDIC" s.c. Artur Racewicz, Jerzy Supronik

location_facility: Private Practice 'Cardiovascular Detection Center'

location_facility: Federal State Budgetary Educational Institution of Higher Education

location_facility: Klinik fur Innere Medizin, Kardiologie und Angiologie MediClin Herzzentrum Lahr/Baden.

location_facility: Bochum Research Centre-Synexus Clinical Research GmbH

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: The Office of Roberto J. Ayala-Rios, MD - Research Center and Private Practice (DMRA LLC)

location_facility: Municipal Budgetary Institution of Healthcare

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Malgorzata Biedrzycka

location_facility: Dept."Medicina lnterna e Specialita Mediche" dell' Universita degli

location_facility: SBHI of Moscow city "City Clinical Hospital #15 n.a. O.M. Filatova"

location_facility: University of Texas Health Science Center San Antonio

location_facility: INGOH - Instituto Goiano de Oncologia e Hematologia

location_facility: State Budgetary Healthcare Institution Of Moscow Region "Lubertsy Regional Hospital #2"

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Institut fuer Klinische Forschung und Entwicklung(IKFE) Berlin GmbH

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Kardiyoloji Bolumu

location_facility: Unidad de Investigacion en Salud de Chihuahua S.C.

location_facility: Klinik und Poliklinik fuer Innere Medizin B - Kardiologie, Angiologie, Pulmologie

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Centro Hospitalario Mac, S.A. de C.V. (Emergencies)

location_facility: UN Bratislava, Nemocnica Ruzinov, V. interna klinika LFUK a UN Bratislava

location_facility: Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Endocrine Lipid Diabetes Research Institute

location_facility: Federal State Budget Institution "Out-patient Clinic #3" of Russian Federation,

location_facility: Baskent University, Adana Yuregir Training & Research Hospital

location_facility: State Autonomous Institution of Healthcare of the Tyumen region Tyumen Institute of Therapy

location_facility: Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.

location_facility: Sydvestjysk Sygehus, Hjertemedicinsk Projektgruppe

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Clinical Research Advantage, Inc./Simon Williamson Clinic

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Wojewodzki Szpital Zespolony w Elblagu, Oddzial Kardiologiczny z Pododdzialem Kardiologii Inwazyjnej

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital

location_facility: CARDIO D&R s.r.o. , Kardiologicka ambulancia

location_facility: Clinical Research Advantage, Inc. (IP Shipment and Research Site)

location_facility: Centro Especializado En Diabetes Y Metabolismo

location_facility: Saint Petersburg State Budgetary Institution of Healthcare Municipal hospital

location_facility: Hospital Mae de Deus/Associacao Educadora Sao Carlos AESC/IMV - Instituto de Medicina Vascular

location_facility: Institut Catala De La Salut - Hospital Universitari Arnau De Vilanova (Huav)

location_facility: UNIFESP - Hospital Sao Paulo - Setor de Lipides, Aterosclerose e Biologia Vascular

location_facility: Southeast Texas Clinical Research Center

location_facility: Brian Y.L. Wong Medicine Professional Corporation

location_facility: Centro de Atencion e Investigacion en Factores de Riesgo Cardiovascular Omega S.C

location_facility: Dr. Mistodie Cristina Victoria MD, Office of

location_facility: Northwest Houston Clinical Research, PLLC

location_facility: Endocrine Unit, Department of Medicine, Phramongkutklao Hospital

location_facility: Instituto de Hematologia y Medicina Clinica "Dr. Ruben A. Davoli"

location_facility: VA North Texas Health Care System - Dallas VAMC

location_facility: Kirov Regional State Budgetary Healthcare Institution "Kirov City Clinical Hospital #1"

location_facility: Hopital Erasme-Universite Libre de Bruxelles (ULB)

location_facility: Affiliate of the Federal State Budgetary Institution Scientific Research Institute of Cardiology

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C.

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Hospital General Universitario de Alicante; Servicio Cardiologia

location_facility: Prywatny Gabinet Lekarski Marianna Janion

location_facility: Baylor University Medical Center / Department of Pharmacy

location_facility: Centro de Especialidades Medicas del Estado de Veracruz

location_facility: The Lindner Center for Research and Education at The Christ Hospital

location_facility: Pro Familia Altera Poradnia Wielospecjalistyczna

location_facility: The First Affiliated Hospital Of Harbin Medical University

location_facility: Hospitalsenheden Midt, Regionshospital Viborg

location_facility: Heart Institute, Bikur Cholim Campus, Shaare Zedek Medical Center

location_facility: Hospital Mexico Americano S.C. (Emergencies)

location_facility: Grand View - Lehigh Valley Health Services, Buxmont Cardiology Division

location_facility: Aarhus Universitetshospital Skejby, Hjertesygdomme ¿ Klinisk Forskning

location_facility: The Heart & Vascular Institute of Florida

location_facility: Dr. Mohan Babapulle Medicine Professional Corporation

location_facility: Klinikum fuer Herz- & Kreislauferkrankungen

location_facility: Diabmed Dr. Popescu Alexandrina SRL, Diabet, Nutritie, Boli Metabolice

location_facility: Clinical Research Advantage, Inc. / Cassidy Medical Group - Vista

location_facility: The University of Texas Southwestern Medical Center

location_facility: Grand Hopital de Charleroi, Site St-Joseph

location_facility: Hospital Universitario De Monterrey- "Doctor Jose Eleuterio Gonzalez"

location_facility: County Clinical Emergency Hospital Sibiu

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Regional Budgetary Healthcare Institution "Cardiology Dispensary"

location_facility: State Healthcare Institution "City Clinical Hospital #51 of Healthcare Department of Moscow City"

location_facility: MedStar Chesapeake CardioVascular Associates

location_facility: INTERCARD Sp. z o.o. Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Krosnie

location_facility: Galilee Medical Center, Cardiology Department

location_facility: Shuali Community Clinic, Clalit Health Services

location_facility: SC Clinica Medicala Synexus SRL, Medicina Interna

location_facility: Limited Liability Company "Institute of Medical research"

location_facility: Metro West Medical Center Research Clinic

location_facility: Municipal Autonomous Institution "City Clinical Hospital #14"

location_facility: Staedtisches Klinikum Muenchen GmbH, Klinikum Neuperlach

location_facility: SPDM Associacao Paulista para o Desenvolvimento da Medicina

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: The Royal Liverpool and Broadgreen -University Hospitals NHS Trust

location_facility: Jardines Hospital de Especialidades S.A de C.V

location_facility: Centre Hospitalier Universitaire de Sherbrooke- Hotel-Dieu

location_facility: Cardiology Consultants of Orange County Medical Group Inc.

location_facility: Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: A.O. di Reggio Emilia Arcispedale "S. Maria Nuova"/IRCCS

location_facility: Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika

location_facility: Consultorio de Endocrinologia y Nutriologia

location_facility: Philadelphia Health Associates-Adult Medicine

location_facility: Hospital de Alta Complejidad "Pte. Juan Domingo Peron"

location_facility: Hospital Regional Universitario de Malaga

location_facility: Centre Integre de Sante et de services sociaux de Chaudiere-Appalaches (CISSS-CA)

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: Hudson Valley Cardiovascular Practice, PC

location_facility: Research Institute of the Carolinas of PiedmontHealthcare, PA

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Duluth Clinic, dba Essentia Health Duluth Clinic Investigational Drug Room

location_facility: Miguel Sosa-Padilla, MD-Private Practice

location_facility: Department of Cardiology, Lyell McEwin Hospital

location_facility: Debreceni Egyetem, I. sz. Belgyogyaszati Klinika

location_facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University"

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran"

location_facility: Fakultni poliklinika Vseobecne fakultni nemocnice v Praze

location_facility: Unicare Heart Institute & Research Center

location_facility: Clinical Research Institute of Northern Virginia

location_facility: Klinika hematologie a transfuziologie, Univerzitna nemocnica Martin

location_facility: Limited Liability Company International Medical Centre SOGAZ

location_facility: Clinical Trial Center (CTC)/Centrum foer klinisk proevning

location_facility: The affiliated Hospital of Xuzhou Medical College

location_facility: PMG Research of Rock Mount, LLC - Patient Intake

location_facility: State Budgetary Educational Institution of Highest Professional Education "Siberian State Medical

location_facility: Cardiology Research Associates of New Brunswick

location_facility: Stredoslovensky Ustav Srdcovych A Cievnych Chorob A.S.

location_facility: Conquest Hospital - East Sussex Healthcare NHS Trust

location_facility: ProMedica Northwest Ohio Cardiology Consultants

location_facility: SBHI of Saint-Petersburg "City Hospital # 38 n.a. N.A. Semashko"

location_facility: SBRIHPE "Novosibirsk State Medical University" of MHSD of RF

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: Federal State Budgetary Institution "Central Clinical Hospital with Polyclinic"

location_facility: Centro de Investigacion Clinica del Pacifico, S.A. de C.V.

location_facility: Municipal Budgetary Institution of Healthcare of Novosibirsk

location_facility: Instituto del Corazon de Bucaramanga S.A.

location_facility: CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Centrum kardiovaskularni prevence 1. LF UK a TN

location_facility: Austin Institute for Clinicla Research,Inc.

location_facility: CARDSEARCH/CARDRESEARCH - Cardiologia Assistencial e de Pesquisa LTDA

location_facility: BKS Research Kft., Albert Schweitzer Korhaz

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "City Alexandrovskaya Hospital"

location_facility: IMC - Instituto de Molestias Cardiovasculares/Equipamentos Cardiovasculares Rio Preto Ltda

location_facility: State Institution of Healthcare "Regional Clinical Hospital"

location_facility: San Diego Family Care dba Linda Vista Health Center

location_facility: Centrum for klinisk provning-Sahlgrenska Universitetssjukhus

location_facility: State Budgetary Healthcare Institution of Nizhegorodskaya Region

location_facility: Clinical Research Advantage, Inc./Michigan Avenue Internists

location_facility: Cap Disset De Setembre (Sant Cosme I Sant Damia)

location_facility: Gulf Coast Endocrine and Diabetes Center

location_facility: Chippenham and Johnston Willis Hospitals, Inc. dba CJW Medical Center

location_facility: Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre

location_facility: Non-State Institution of Healthcare "Railway Clinical Hospital at station Chelyabinsk of open

location_facility: The Red Porto cabin, The James Cook University Hospital

location_facility: Mercy Health Youngstown, LLC d/b/a St. Elizabeth Youngstown Hospital

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

location_facility: Instituto De Cardiologia Do Distrito Federal

location_facility: Department of Neurology & Sagol Neuroscience Center

location_facility: CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC

location_facility: Instituto de Cardiologia de Corrientes "Juana Fca. Cabral"

location_facility: Region Sjaelland Sygehus Nord, Koge Sygehus

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.

location_facility: Research Institute of South Florida, Inc.

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego

location_facility: Municipal Budgetary State Healthcare Institution "City Clinical Hospital #6"

location_facility: CISSS des Laurentides-Point de Service de St-Jerome- Comite d'ethique de la recherche

location_facility: Department of Clinical Medicines and Cardiovascular Sciences, Universita "Federico II" di Napoli

location_facility: State Budgetary Educational Institution of Higher Professional Education

location_facility: Federal State Budgetary Institution "Russian Cardiology Research And Production Complex" Of Ministry

location_facility: Centro Cientifico Asistencial Jose Luis Accini S.A.S.

location_facility: Hospital Universitario San Cecilio de Granada

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Hospital Inovamed Cuernavaca (Emergencies)

location_facility: Endiamed s.r.o. Nestatna diabetologicka a endokrinologicka ambulancia

location_facility: Federal state budgetary institution Research institute of complex problems

location_facility: MetroWest Medical Center - Pharmacy Department

location_facility: Cardiovascular Research Center of South Florida

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Southern Adelaide Diabetes and Endocrine Service

location_facility: Fundacion del Caribe Para La Investigacion Biomedica - Fundacion BIOS

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, S.C.

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

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, l.interna klinika

location_facility: Fundacion Cardiovascular De Colombia - Instituto del Corazón Floridablanca

location_facility: Vita Health & Medical Center, Inc./Concept Clinical Trials, LLC

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: Policlinico Umberto I di Roma - DAI Malattie Cardiovascolari e Respiratorie

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Hospital Universitário Sao José / FELUMA - MG

location_facility: Synexus Leipzig Clinical Research Centre

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M. Zabowka E. Zabowka

location_facility: Salford Royal NHS Foundation Trust - Dermatology Centre

location_facility: McGlone Practice Baillieston Health Centre

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation

location_facility: Gemeinschaftspraxis Drs Haggenmiller/Jeserich, Kardiologie, Angiologie, Innere Medizin

location_facility: Centro de Medicina del Ejercicio y Rehabilitacion Cardiac - CEMDE S.A.

location_facility: Novant Health Heart and Vascular Institute

location_facility: The Michael White Centre for Diabetes & Endocrinology, Hull Royal Infirmary

location_facility: Austin Health - Heidelberg Repatriation Hospital

location_facility: HealthEast St. Joseph's Hospital Pharmacy

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Inner Mongolia Autonomous Region People's Hospital

location_facility: National Cheng Kung University (NCKU) Hospital

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Azienda Ospedaliera Universitaria Santa Maria Della Misericordia

location_facility: LMC Diabetes & Endocrinology (Thornhill)

location_facility: Broward Health Medical Center (BHMC) (Broward General Medical Center (BGMC))

location_facility: Hospital Interzonal Gral. de Agudos Dr. Jose Penna

location_facility: Instituto de Diabetes Obesidad y Nutricion, S.C.

location_facility: Kardiocentrum Nitra s.r.o., kardiologicka ambulancia

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: FSBEI of HE Kazan State Medical University on the base of SBHI Clinical Hospital No.2

location_facility: Hospital de Messejana Dr Carlos Alberto Studart Gomes

location_facility: Sociedade Hospitalar Angelina Caron/Hospital e Maternidade Angelina Caron

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie,

location_facility: NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp. z.o.o.

location_facility: CIPADI Centro Integral de Prevencion y Atencion en Diabetes

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Instituto Domingo Braile _ Braile Hospital Dia LTDA

location_facility: Forskningsenheten, Medicinmottagningen Sahlgrenska Universitetssjukhuset/Molndal, Hus J

location_facility: IRCCS Centro Cardiologico Fondazione Monzino

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital - New

location_facility: Scarborough Cardiology Research Associates Inc.

location_facility: PMG Research,Inc d/b/a PMG Research of Knoxville

location_facility: Ospedale Civile Regionale San Martino, Belluno

location_facility: Hospital Angeles Culiacan (Emergencies Only)

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi 251 Pomorska

location_facility: Hospital Provincial Dr. Jose Maria Cullen

location_facility: Fundacion Santos y de la Garza Evia I.B.P. (Centro Medico Zambrano Hellion)

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Hospital Clinico Universitario Miguel Servet; Medicina Interna

location_facility: Division Of cardiology,Department of Medicine,Faculty Of Medicine,Chulalongkorn University

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Liga Mineira de Ressuscitacao Cardiopulmonar

location_facility: Clinique des maladies lipidiques de Quebec

location_facility: State Budgetary Institution of Healthcare of Kaluga Region "Kaluga Regional Hospital"

location_facility: Centre hospitalier de Jolimont-Lobbes - Centre de Recherche Medicale de Jolimont

location_facility: Operadora de Hospitales Angeles S.A. de C.V.(Emergencies)

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Centrum Badan Klinicznych Pi-House, Poradnia Diabetologiczna

location_facility: Presidioospedaliero di san dona 'di PIAVE

location_facility: Foothills Hospital/University of Calgary

location_facility: AMH/Feasterville Family Health Care Center

location_facility: State Budgetary Institution "Ryazan Regional Clinical Hospital"

location_facility: Clinical Research Associates of Central PA

location_facility: Hopital Arnaud de Villeneuve - CHU Montpellier

location_facility: Arcturus Healthcare, PLC, Troy Internal Medicine Research Division

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: I.N.R.C.A. di Ancona Ospedale Geriatrico

location_facility: Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU

location_facility: AOUI di Verona - Ospedale Civile Maggiore Borgo Trento

location_facility: Kernodle Clinic, Department of the Private Diagnostic Clinic, PLLC

location_facility: Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran

location_facility: MedStar Union Memorial Heart Specialists

location_facility: Clinical Research Center, Phramongkutklao Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Stroke Prevention & Atherosclerosis Research Centre (SPARC)-Siebens-Drake Research Institute

location_facility: Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Oddzial

location_facility: State Autonomous Healthcare Institution of Yaroslavl region

location_facility: Holy Spirit Northside Private Hospital Limited

location_facility: Sir Charles Gairdner Hospital, Heart Research Institute

location_facility: Medica Pro Familia Sp. z o.o. Spolka Komandytowo Akcyjna, Oddzial w Gdyni

location_facility: "Limited Liability Company ""Institute of Medical Research"""

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The First Affiliated Hospital Of Zhengzhou University

location_facility: Centro de Diagnostico Cardiologico LTDA.

location_facility: Non-State Institution of Healthcare "Central Clinical Hospital #6 OAO "RZhD"

location_facility: Cardiovascular Research Foundation of Southern California

location_facility: Irmandade Da Santa Casa De Misericordia De Porto Alegre - ISCMPA

location_facility: The University of Texas Health Science Center at Houston- UT Physicians

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Pecsi Tudomanyegyetem AOK, I. Belgyogyaszati Klinika

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Insituto de Cardiologia de Santa Catarina

location_facility: Suzhou Kowloon Hospital Shanghai Jiaotong University School of Medicine

location_facility: Hospital Alvaro Cunqueiro (Hospital Meixoerio)

location_facility: Elisabeth-TweeSteden Ziekenhuis (previously named St. Elisabeth Ziekenhuis)

location_facility: Memorial Hermann Hospital, Texas Medical Center- UT Health Clinical Research Unit

location_facility: NeuroCor Banaszkiewicz, Kulaga, Ostrowska, Tomaszewski lekarze spolka partnerska

location_facility: Memorial Hermann Hospital, Texas Medical Center

location_facility: State Budgetary Healthcare Institution "Research Institution - Regional Clinical Hospital #1

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu

location_facility: Gabinet Lekarski Malgorzata Saryusz-Wolska

location_facility: Groupe Hospitalier de Pellegrin Hopital Pellegrin

location_facility: Black Hills Cardiovascular-Regional Health Research

location_facility: FGM-Clinica Paulista de Doencas Cardiovasculares

location_facility: Federal State Budgetary Institution "Research Institute of Therapy and Preventive Medicine" of

location_facility: South Florida Clinical Research Institute

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: IP + Dry ice deliveries Sugar Lakes Family Practice

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Midwest Heart & Vascular Specialists, LLC

location_facility: Centrum Zdrowia Metabolicznego Pawel Bogdanski

location_facility: Hospital Universitario Virgen de las Nieves (HUVN)

location_facility: Heart Institute, Hillel Yaffe Medical Center

location_facility: Hospital Universitario - Associacao Educadora Sao Carlos - AESC

location_facility: Dr. Kapil M. Bhagirath Medical Services Corporation

location_facility: The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: FSHI "Medical and Sanitary Unit of the Ministry of Internal Affairs of Russia across Kemerovo region

location_facility: Roodepoort Medicross Clinical Research Centre

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: University Hospital Brussels- Diabeteskliniek

location_facility: Clinical Research Advantage, Inc./Skyline Medical Center, PC

location_facility: William P. Clements Jr. University Hospital

location_facility: Gefen Institute for Research and Cardiac Health

location_facility: John Muir Physician Network Clinical Research Center

location_facility: NZOZ "PRO CORDIS" Sopockie Centrum Badan Kardiologicznych

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Centre integre de sante et de services sociaux de Lanaudiere (CISSSL)

location_facility: Clinical Research Advantage, Inc./Medical and Procedural Specialists of Illinois

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s.

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Diabet Zaharat, Nutritie si Boli Metabolice

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: ILAIM Instituto Latinoamericano de Investigaciones Medicas

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera S'Andrea di Roma - UOC Cardiologia

location_facility: Fakultna Nemocnica s poliklinikou Nove Zamky

location_facility: SBEI of HPE Kazan State Medical University on the base of SBHI Clinical Hospital No.2

location_facility: Centro De Investigaciones Clinicas Del Litoral S.R.L.

location_facility: "SBHI of Novosibirsk ""City Clinical Hospital of Emergency Medical Care # 2"""

location_facility: General Hospital Of Ningxia Medical University

location_facility: Staedtische Kliniken Bielefeld Gem. GmbH - Klinikum Mitte

location_facility: Via Medica - Clinica Medica Integrada Ltda - Barroso e Sebba Ltda

location_facility: Hospital Universitario de Santiago de Compostela

location_facility: Premier Health Specialists, Inc (dba Dayton Heart Center)

location_facility: Spitalul Universitar De Urgenta Militar Central, Dr. Carol Davila

location_facility: The First Affiliated Hospital of Habrin Medical University

location_facility: Centrum Medyczne Warszawskiego Uniwersytetu Medycznego Sp. z o.o

location_facility: Prywatny Gabinet Lekarski Dr n. med. Michal Ogorek

location_facility: Moscow State Healthcare Institution "City clinical hospital n.a. S.P.Botkin"

location_facility: Institute of Cardiovascular Diseases Timisoara

location_facility: Regionshospitalet Silkeborg, Hjerte Projektkontor

location_facility: Centro de Pesquisas Medicas Basica e Clinica LTDA

location_facility: North Ohio Heart Center (Administrative Only)

location_facility: Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)

location_facility: METABOL KLINIK s. r.o., Ambulancia pre diabetologiu, poruchy latkovej premeny a vyzivy

location_facility: Comed Care Empresa de Atendimento Clinico Geral - LTDA - Hospital Total Care

location_facility: University of Iowa College of Public Health - Preventive Intervention Center

location_facility: London Road Diagnostic Clinic and Medical Centre

location_facility: AOU Policlinico "Mater Domini" UOC di Medicina interna

location_facility: Marek Piepiorka Gabinet Kardiologiczno - lnternistyczny

location_facility: State Budgetary Healthcare Institution "Samara Regional Clinical Cardiology Dispensary"

location_facility: Hopital Cardiovasculaire Et Pneumologique Louis Pradel

location_facility: Instituto Medico CENICLAR - Central de Investigaciones Clinicas Argentina -Sanatorio de la Mujer

location_facility: Clinresco Centres (Pty) Ltd-Central Professional Suits

location_facility: Centro de Investigaciones Clinicas "Instituto del Corazon"

location_facility: Pharmacology and Clinical Research S.A. de C.V.

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino-Metabolicas Ltda

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, l.intema klinika

location_facility: Cardio D&R spol.s.r.o., Kardiologicka ambulancia

location_facility: Instituto de Cardiologia y Cirugia Cardiovascular - Fundacion Favaloro

location_facility: Lillehei Clinical Research Unit, University of Minnesota

location_facility: State Healthcare Institution of Yaroslavl Region "Clinical Hospital #8"

location_facility: Canadian Centre for Research on Diabetes

location_facility: Caprock Cardiac Center Research Institute Inc.

location_facility: Federal State Budgetary Institution "Advisory Diagnostic Center and Polyclinic"

location_facility: Divisione di Cardiologia con UTIC ed Emodinamica

location_facility: Instituto de Investigacion Endocrinologia y Prevencion Metabolica - ENDOCARE LTDA.

location_facility: John V. Bernard, MD dba Wellness and Research Center

location_facility: DIAMEL, s.r.o., Diabetologicka ambulancia

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, III. Belgyogyaszat-Kardiologiai Osztaly

location_facility: Caja de Compensacion Familiar CAFAM, Sede Centro de Atencion en Salud CAFAM FLORESTA

location_facility: Hospital Universitario La Paz; Unidad Metabolico-Vascular

location_facility: FSBEI of HE "Yaroslavl State Medical University" MH of the Russian Federation

location_facility: University hospitals Leuven - Cardiology department

location_facility: Specjalistyczne Gabinety Lekarskie "Medicor Plus" - Jerzy Kopaczewski

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego Klinika Kardiologii

location_facility: Aster Aadhar Hospital (Prerana Hospital Ltd.)

location_facility: Recep Tayyip Erdogan University School of Medicine, Training & Research Hospital

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Glacier View Research Institute, Cardiology

location_facility: Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

location_facility: Universitaets Herzzentrum Freiburg Bad Krozingen

location_facility: Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Landa Specjalistyczne Gabinety Lekarskie

location_facility: Wake Forest University School of Medicine

location_facility: Advanced Clinical Research of Miami (ACROM) International

location_facility: Rutgers Biomedical and Health Sciences-Robert Wood Johnson Medical School

location_facility: Bogna Gabrylewicz Andrzej Ochala Unimed s.c.

location_facility: Liptovska nemocnica s poliklinikou MUDr.Ivana Stodolu Liptovsky Mikulas

location_facility: CCBR - Centro de Pesquisas e Analises Clinicas LTDA

location_facility: Detweiler Family Medicine & Associates, PC

location_facility: Centro de Investigacion Clinica Avanzada y Multidisciplinaria CICLAM

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes S.A. de C.V.

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Philippe R. Beaudry Medicine Professional Corporation

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: AOU Policlinico "P. Giaccone" Dipartimento delle Patologie Emergenti, Unita di Medicina Interna

location_facility: Dumlupinar Universitesi Kutahya Evliya Celebi EAH

location_facility: Liga Mineira de Ressucitacao cardiopulmonar

location_facility: Ribo Research, LLC dba Peninsula Research

location_facility: Clinical Trials Unit,Bay of Plenty(BOP) Clinicla School

location_facility: Clinica Privada de Especialidades Medicas

location_facility: SBEI of HPE "First Pavlov State Medical University of St. Petersburg" of the MOH of the RF

location_facility: IKF Institut fuer klinische Forschung Frankfurt

location_facility: State Regional Budgetary Healthcare Institution

location_facility: Doylestown Health Cardiology, a division of Doylestown Health Physicians

location_facility: Zentrum Klinische Studien Neuwied (ZKSN)

location_facility: POLIKUM Institut GmbH, Polikum Berlin Friedenau

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Istanbul Universitesi Kardiyoloji Enstitusu

location_facility: Josephs-Hospital Warendorf Med. Klinik II, Kardiologie/Angiologie

location_facility: Optimamed Specjalistyczne Gabinety Lekarskie

location_facility: Jeleniogorskie Centrum Chorob Serca, Przychodnia Kardiologiczna, Poradnia Kardiologiczna

location_facility: Allina Health System, dba Abbott Northwestern Hospital

location_facility: Northeast Iowa Medical Education Foundation

location_facility: Consultorio Dr. Leocadio Gerardo Munoz Beltran

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: Sparrow Thoracic & Cardiovascular Institute

location_facility: Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V.

location_facility: Santa Casa de Misericordia de Votuporanga

location_facility: Southeast Texas Cardiology Associates II, L.L.P.

location_facility: Quanta Diagnostico e Terapia / Medicina Nuclear Alto da XV

location_facility: The First Affiliated Hospital Of Xinjiang Medical University

location_facility: Maerkische Kliniken GmbH, Klinikum Luedenscheid, Innere III

location_facility: GBOU VPO Siberian State Medical University Ministry of Healthcare of the Russian Federation

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: University of Texas Southwestern Medical Center

location_facility: Acacia Medical Research Institute, LLC/Royal Oaks Medcical Home and Wellness Clinics

location_facility: Karlkliniken, Skanes Universitetssjukhus i Malmo

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Russian Cardiology Research And Production Complex of Ministry of Health of Russian Federation

location_facility: Clinical Research Advantage, Inc. / Family Medicine Associates

location_facility: Clinphenomics Gmbh & Co Kg, Studienzentrum

location_facility: Azienda Ospedaliera Della Provincia Di Lecco - Ospedale Manzoni

location_facility: "SAHI of Kemerovo ""Regional Clinical Hospital of Emergency Medical Care n.a. M.A Podgorbunsky """

location_facility: Specjalistyczna Praktyka Lekarska Piotr Kubalski

location_facility: New Orleans Center for Clinical Research

location_facility: Pfuetzner Science & Health Institute-Gmbh

location_facility: Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders

location_facility: Tyumen Cardiology Research Center-branch of the Tomsk NRMC

location_facility: Hospital Universitario Sant Joan de Reus

location_facility: Helsingin yliopistollinen keskussairaala, Sisaetaudit ja kuntoutus, Biomedicum 2U

location_facility: Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny Boguslaw Derlaga

location_facility: Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

location_facility: State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital of Emergency

location_facility: Westside Medical Associates of Los Angeles

location_facility: Gemeinschaftspraxis fuer Kardiologie Dres. Med. Willgeroth/Wetzel

location_facility: The Office of Daniel W. Gottlieb, MD, PS

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Clinica Nuevas Tecnologias en Diabetes y Endocrinologia

location_facility: Cardiology Unit, Department of Medicine, Faculty of Medicine,Ramathibodi Hospital,Mahidol University

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "City Hospital #15"

location_facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona U.O.C. UTIC

location_facility: Hospital General Comarcal de Elda Virgen de la Salud

location_facility: County Clinical Emergency Hospital Oradea

location_facility: Hospital Lifecenter / Lifecenter Sistema de Saude S.A

location_facility: "Hospital Central ""Dr. Ignacio Morones Prieto"""

location_facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Egitim ve Arastirma Hastanesi

location_facility: State Budgetary Institution of Healthcare"Penzenskaya Regional clinical hospital n.a N.N Burdenko"

location_facility: Hospital General Universitario Morales Meseguer

location_facility: SMO.MD GmbH, Zentrum fuer klinische Studien Site Management and Clinical Research Unit

location_facility: Metabolicke centrum MUDr. Katariny Raslovej, s.r.o.

location_facility: Apex Heart Institute (A Unit of TCVS Pvt. Ltd)

location_facility: Cardiovascular Clinical Research Institute

location_facility: The Queen Elizabeth University Hospital- NHS Greater Glasgow and Clyde

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Complexo Hospitalario Universitario Arquitecto Marcide-Profesor Novoa Santos De Ferrol

location_facility: Fundacion Centro de Obesidad y Metabolismo COMETA

location_facility: UN Bratislava Nemocnica Sv. Cyrila a Metoda, kardiologicka ambulancia 1

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: S.C. Centrul Medical "Sanatatea Ta" S.R.L.

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: MUDr. Kanderkova s.r.o., Diabetologicka ambulancia

location_facility: Kocaeli University School Of Medicine-Kocaeli Universitesi Tip Fakultesi

location_facility: Solano & Terront Servicios Medicos Ltda-Establecimiento Comercial UNIENDO

location_facility: Hospital E Maternidade Celso Pierro PUC - Campinas - Sociedade Campineira de Educacao e Instrucao

location_facility: West Jefferson Heart Clinic of Louisiana New Orleans Physician Services, Inc.

location_facility: Heart of England NHS Foundation Trust, Dept. of Clinical Biochemistry & Immunology

location_facility: St. Mary's Medical Center (Primary Practice Site)

location_facility: Peart-Rose Research Unit, Hammersmith Hospital, Imperial College NHS Trust

location_facility: Abertawe Bro Morgannwg University Local Health Board

location_facility: Unidad de Investigacion Clinica y Atencion Medica HEPA S.C.

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Dokuz Eylul Univesitesi Tip Fakultesi Hastanesi

location_facility: Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

location_facility: Klinik Am See - Klinik Am See - Rehabilitationszentrum Fur Innere Medizin


title: A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

summary: The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Netherlands
Austria
Belgium
United States
Spain
Turkey
Canada
France

location_facility: Evanstan Northwestern Healthcare Medical Group

location_facility: Neurology & Neuroscience Associates, Inc.

location_facility: Veterans Affairs Puget Sound Health Care System

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: TOPIC

lead_sponsor: Sanofi

summary:
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

To demonstrate the effect of teriflunomide, in comparison to placebo, on:

Reducing conversion to definite multiple sclerosis (DMS)
Reducing annualized relapse rate (ARR)
Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
Proportion of disability-free participants as assessed by the EDSS
Reducing participant-reported fatigue
To evaluate the safety and tolerability of teriflunomide
To evaluate the pharmacokinetics (PK) of teriflunomide
Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

ReferenceType: background

ReferenceCitation: Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2.

location_facility:
Investigational Site Number 7401
Investigational Site Number 7806
Investigational Site Number 5805
Investigational Site Number 6201
Investigational Site Number 8951
Investigational Site Number 8940
Investigational Site Number 7709
Investigational Site Number 7808
Investigational Site Number 7911
Investigational Site Number 8308
Investigational Site Number 7807
Investigational Site Number 8505
Investigational Site Number 8949
Investigational Site Number 6203
Investigational Site Number 6605
Investigational Site Number 6804
Investigational Site Number 7402
Investigational Site Number 6609
Investigational Site Number 8309
Investigational Site Number 7501
Investigational Site Number 8314
Investigational Site Number 5410
Investigational Site Number 7101
Investigational Site Number 8305
Investigational Site Number 4005
Investigational Site Number 8946
Investigational Site Number 8506
Investigational Site Number 7907
Investigational Site Number 6815
Investigational Site Number 8315
Investigational Site Number 6807
Investigational Site Number 6809
Investigational Site Number 6803
Investigational Site Number 5601
Investigational Site Number 6805
Investigational Site Number 5306
Investigational Site Number 5404
Investigational Site Number 7909
Investigational Site Number 8941
Investigational Site Number 6806
Investigational Site Number 8510
Investigational Site Number 8701
Investigational Site Number 5801
Investigational Site Number 8937
Investigational Site Number 8501
Investigational Site Number 8303
Investigational Site Number 8706
Investigational Site Number 8503
Investigational Site Number 8502
Investigational Site Number 7108
Investigational Site Number 7905
Investigational Site Number 8965
Investigational Site Number 5403
Investigational Site Number 8301
Investigational Site Number 8709
Investigational Site Number 6403
Investigational Site Number 7703
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title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

type: EudraCT Number

source: euctr

study_completion_date_type: Actual

location_country:
Finland
Germany
Poland
Australia
Turkey
Chile
Canada
France
Czech Republic
Lithuania
Hungary
Denmark
United States
Ukraine
Romania
Estonia
United Kingdom
Austria
Mexico
Bulgaria
Russian Federation


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

acronym: SPARTAN

summary: The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Pollock Y, Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik B, Olmos D, Lee JY, Uemura H, Bhaumik A, Londhe A, Rooney B, Brookman-May SD, De Porre P, Mundle SD, Small EJ. Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):156-161. doi: 10.1038/s41391-022-00592-9. Epub 2022 Oct 8. Erratum In: Prostate Cancer Prostatic Dis. 2023 Dec;26(4):813.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

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

version: acceptedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: hybrid

ReferenceCitation: Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0. Erratum In: BMC Urol. 2020 Oct 22;20(1):166.

oa_colors: green gold

evidence: oa journal (via doaj)

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

unpaywall_oa_status: gold

ReferenceCitation: Smith MR, Mehra M, Nair S, Lawson J, Small EJ. Relationship Between Metastasis-free Survival and Overall Survival in Patients With Nonmetastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2020 Apr;18(2):e180-e189. doi: 10.1016/j.clgc.2019.10.030. Epub 2019 Nov 6.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Elsevier

ReferenceCitation: Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, Graff JN, McQuarrie K, Li S, Hudgens S, Lawson J, Lopez-Gitlitz A, Yu MK, Smith MR, Small EJ. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1404-1416. doi: 10.1016/S1470-2045(18)30456-X. Epub 2018 Sep 10.

oa_host_type: repository

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8.

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Turin - Institutional Research Information System University of Turin

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Tampere University - Tampere University Institutional Repository

location_country:
Finland
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Slovakia
Hungary
Denmark
United States
Romania
Belgium
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: PROTEC

lead_sponsor: Biogen

summary:
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.

The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.

ReferenceCitation: Berger T, Brochet B, Brambilla L, Giacomini PS, Montalban X, Vasco Salgado A, Su R, Bretagne A. Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC. Mult Scler J Exp Transl Clin. 2019 Dec 2;5(4):2055217319887191. doi: 10.1177/2055217319887191. eCollection 2019 Oct-Dec. Erratum In: Mult Scler J Exp Transl Clin. 2020 Apr 29;6(2):2055217320921146.

repository_institution: PubMed Central - Europe PMC

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Hospital Prof. Dr. Fernando Fonseca - The Institutional Repository of Hospital Prof. Dr. Fernando Fonseca

publisher_dissemination: SAGE Publications

title: A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting

location_country: Slovenia Italy Portugal Slovakia Hungary Austria Belgium Spain Czechia Canada France


title: A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML).

acronym: OPTIM-DASA

summary:
This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC).

The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib.

The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.

The study will be conducted in selected FILMC and Canadian centers.

The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.

ReferenceCitation: Rousselot P, Mollica L, Guilhot J, Guerci A, Nicolini FE, Etienne G, Legros L, Charbonnier A, Coiteux V, Dartigeas C, Escoffre-Barbe M, Roy L, Cony-Makhoul P, Dubruille V, Gardembas M, Huguet F, Rea D, Cayssials E, Guilhot F, Bergeron A, Molimard M, Mahon FX, Cayuela JM, Busque L, Bouchet S. Dasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients. Br J Haematol. 2021 Jul;194(2):393-402. doi: 10.1111/bjh.17654. Epub 2021 Jun 30.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: Versailles Hospital

sponsor_collaborators:
Versailles Hospital
Maisonneuve-Rosemont Hospital
University Hospital, Bordeaux

location_country: Canada France

location_facility: Hôpital Général Juif - Sir. Mortimer B. Davis

location_facility: Southern Alberta Cancer Research Institute

location_facility: Pavillon Hôtel-Dieu de Québec - Centre hospitalier universitaire de Québec

location_facility: Queen elisabeth II Health Sciences Center

location_facility: Hôpital de l'Enfant Jésus - Centre hospitalier affilié universitaire de Québec

lead_sponsor_type: academique


acronym: COLUMBUS

lead_sponsor: Pfizer

summary:
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.

Part 1:

Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:

LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
vemurafenib 960 mg BID (denoted as vemurafenib arm)

Part 2:

Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:

LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

ReferenceCitation: Dummer R, Flaherty KT, Robert C, Arance A, de Groot JWB, Garbe C, Gogas HJ, Gutzmer R, Krajsova I, Liszkay G, Loquai C, Mandala M, Schadendorf D, Yamazaki N, di Pietro A, Cantey-Kiser J, Edwards M, Ascierto PA. COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients With BRAF V600-Mutant Melanoma. J Clin Oncol. 2022 Dec 20;40(36):4178-4188. doi: 10.1200/JCO.21.02659. Epub 2022 Jul 21. Erratum In: J Clin Oncol. 2023 Apr 20;41(12):2301.

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Gogas H, Dummer R, Ascierto PA, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Sileni VC, Dutriaux C, Yamazaki N, Loquai C, Queirolo P, Jan de Willem G, Sellier AT, Suissa J, Murris J, Gollerkeri A, Robert C, Flaherty KT. Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS). Eur J Cancer. 2021 Jul;152:116-128. doi: 10.1016/j.ejca.2021.04.028. Epub 2021 Jun 4. Erratum In: Eur J Cancer. 2022 Jan;160:287-288.

ReferenceCitation: Gogas HJ, Flaherty KT, Dummer R, Ascierto PA, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Sileni VC, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Gollerkeri A, Pickard MD, Robert C. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management. Eur J Cancer. 2019 Sep;119:97-106. doi: 10.1016/j.ejca.2019.07.016. Epub 2019 Aug 19.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Dummer R, Ascierto PA, Gogas HJ, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Chiarion Sileni V, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Moutouh-de Parseval LA, Pickard MD, Sandor V, Robert C, Flaherty KT. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1315-1327. doi: 10.1016/S1470-2045(18)30497-2. Epub 2018 Sep 12. Erratum In: Lancet Oncol. 2018 Oct;19(10):e509.

ReferenceCitation: Dummer R, Ascierto PA, Gogas HJ, Arance A, Mandala M, Liszkay G, Garbe C, Schadendorf D, Krajsova I, Gutzmer R, Chiarion-Sileni V, Dutriaux C, de Groot JWB, Yamazaki N, Loquai C, Moutouh-de Parseval LA, Pickard MD, Sandor V, Robert C, Flaherty KT. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018 May;19(5):603-615. doi: 10.1016/S1470-2045(18)30142-6. Epub 2018 Mar 21.

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

location_facility: Institut für Diagnostische und Interventionelle Radilogie

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Überörtliche Radiologische Gemeinschaftspraxis Dresden

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centro Hospitalar de Lisboa Norte E.P.E - Hospital Pulido Valente - PPDS

location_facility: Sifa Universitesi Bornova Egitim Arastirma Hastanesi

location_facility: Istituto Clinico Humanitas - Humanitas Cancer Center

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: National Cancer Centre - 30 Hospital Blvd

location_facility: Centre Hospitalier Universitaire de Quebec - Hotel - Dieu de Quebec - Universite Laval

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Jackson Oncology Associates - St. Dominic Hospital

location_facility: IRCCS Az. Osp. Universitaria San Martino- IST

location_facility: Medica Sur, S. A. B de C. V. (Centro de Investigación Farmacológica y Biotecnológica CIF-BIOTEC)

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Mercy Health Hauenstein Neuroscience Center Neuro-Ophthalmology (Clinic)

location_facility: Institut für diagnostische und interventionelle Radiologie

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Klinik und Poliklinik für Augenheilkunde

location_facility: Centre de Sante Et Services Sociaux Richelieu Yamaska

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Hôpital D'Instruction des Armées Desgenettes

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Oslo universitetssykehus HF, Utprøvingsenheten

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Universitätsklinik für Radiologie und Nuklearmedizin

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: Diagnostische und interventionelle Radiologie und Neuroradiologie

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Lack's Cancer Center at Mercy Health Saint Mary's

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Investigational Drug Service, Department of Pharmacy (Investigational Product)

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Hospital Universitario Virgen De La Arrixaca

location_facility: Hospital Regional Universitario de Malaga ? Hospital General

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi-Via Massarenti

location_facility: Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Internistische Schwerpunktpraxis Kardiologie Hämatologie Onkologie

location_facility: Erasmus MC-Daniel den Hoed Oncologisch Centrum

location_facility: Sir Charles Gairdner Hospital Pharmacy Department

location_facility: Fachklinik Hornheide Abteilung für Internistische Onkologie und Hämatologie

location_facility: Centre Hospitalier De L'Universite De Montreal Hospital Notre Dame

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Hospital General Universitario de Alicante

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Instituto Nacional de Cardiología Ignacio Chavez

location_facility: Azienda Ospedaliera Civile Maria Paternò Arezzo Ragusa

location_facility: University Hospital Carl Gustav Carus Dersden

location_facility: Virginia Cancer Specialists (Leesburg) - USOR

location_facility: Hautklinik, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital General Universitario Dr. Balmis

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Institut für Diagnostische und Interventionelle Radiologie

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Institut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin

location_facility: IRCCS Giovanni Paolo II Cancer Institute

location_facility: The Royal Marsden in Sutton, Surrey - Downs Rd

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Northern Virginia Ophthalmology Associates

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Azienza Ospedaliera Universitaria Senese

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Universitätsklinikum Freiburg, Klinik für Radiologie

location_facility: Hygeia Diagnostic and Therapeutic Centre of Athens

location_facility: University of Rochester Medical Center - PPDS

location_facility: University of Illinois Hospital and Health Sciences System - Investigational Drug Service

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Switzerland
United States
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel

ipd_sharing: Yes

status_simplified: Ongoing


lead_sponsor: Hoffmann-La Roche

summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

ReferenceCitation: Stilgenbauer S, Bosch F, Ilhan O, Kisro J, Mahe B, Mikuskova E, Osmanov D, Reda G, Robinson S, Tausch E, Turgut M, Wojtowicz M, Bottcher S, Perretti T, Trask P, Van Hoef M, Leblond V, Foa R. Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study. Br J Haematol. 2021 Apr;193(2):325-338. doi: 10.1111/bjh.17326. Epub 2021 Feb 19.

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

repository_normalized: HAL

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

repository_institution: Ulm University - OPen Access Repositorium der Universität Ulm (OPARU)

ReferenceCitation: Bosch F, Cantin G, Cortelezzi A, Knauf W, Tiab M, Turgut M, Zaritskey A, Merot JL, Tausch E, Trunzer K, Robson S, Gresko E, Bottcher S, Foa R, Stilgenbauer S, Leblond V. Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study. Leukemia. 2020 Feb;34(2):441-450. doi: 10.1038/s41375-019-0554-1. Epub 2019 Aug 27.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Stilgenbauer S, Leblond V, Foa R, Bottcher S, Ilhan O, Knauf W, Mikuskova E, Renner C, Tausch E, Woszczyk D, Gresko E, Lundberg L, Moore T, Morris T, Robson S, Bosch F. Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study. Leukemia. 2018 Aug;32(8):1778-1786. doi: 10.1038/s41375-018-0146-5. Epub 2018 Apr 27.

evidence: open (via page says license)

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

location_facility: Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I

location_facility: University Hospital of Ioannina; Hematology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Soroka Medical Center; Hematology Deptartment

location_facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Az. Osp. Pugliese; Divisione de Ematologia

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Hospital Estadual do Servidor Publico; Hematologia

location_facility: Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w.

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Fakultna Nemocnica Roosevelta; Dept. of Haematology

location_facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia

location_facility: Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi

location_facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

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

location_facility: North Estonia Regional Hospital; Hematology

location_facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin

location_facility: AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia

location_facility: Hospital Infanta Leonor; Servicio de Hematologia

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine

location_facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología

location_facility: Turku Uni Central Hospital; Dept of Internal Medicine

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Arcispedale S. Anna; Sezione Di Ematologia

location_facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

location_facility: Hopital Cote De Nacre; Hematologie Biologique

location_facility: Azienda ospedaliera oo rr di foggi; Hematology

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Hospital Universitario Reina Sofia; Servicio de Hematologia

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Hospital Quiron de Madrid; Servicio de Hematologia

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Centro Medico Nacional Sxxi - Imss; Haematology

location_facility: Hospital De Txagorritxu; Servicio de Hematologia

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: University Clinical Center Sarajevo, Clinic for Hematology

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Onkologisches Zentrum am Bethanien-Kankenhaus

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Clinical Center Ljubljana; Haematology Dept

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Bnei-Zion Medical Center; Hematology Dept

location_facility: Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Centre Hospitalier René Dubos; Hematologie

location_facility: Hadassah Ein Karem Hospital; Haematology

location_facility: Cairo University Hospital Al Kasr El Ainy

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Hospital San Pedro De Alcantara; Servicio de Hematologia

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: Gaziantep University Medical School; Hematology

location_facility: Universitetssjukhuset i Linköping, Hematologkliniken

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

location_facility: Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Regional health authority A vitalite health network

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology

location_facility: University Clinic of Hematology Skopje, Hospital Care Department

title: A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

location_country:
Finland
Germany
Ireland
Poland
Argentina
Brazil
Bosnia and Herzegovina
Thailand
Turkey
Canada
Serbia
France
Slovenia
Lithuania
Portugal
Slovakia
Switzerland
Latvia
North Macedonia
Romania
Belgium
Estonia
Egypt
Italy
Sweden
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel