title: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

summary: The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

ReferenceCitation: Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.

name: From Gustave Roussy, INSERM Unité 981, Université Paris-Sud, Université Paris-Saclay, Villejuif, France (Y.L.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Genitourinary and Gynecological Cancer Unit, Centro Integral Oncológico Clara Campal, Madrid (J.G.-D.), Hospital Clinic Institut d’Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona (B.M.), and Hospital Universitario Marques de...

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Necchi

full_name: Andrea Necchi

family: Park

full_name: Se Hoon Park

given: Se Hoon

family: Garcia-Donas

full_name: Jesus Garcia-Donas

given: Jesus

family: Huddart

full_name: Robert Huddart

given: Robert

family: Burgess

full_name: Earle Burgess

given: Earle

family: Fleming

full_name: Mark Fleming

given: Mark

family: Rezazadeh

full_name: Arash Rezazadeh

given: Arash

family: Mellado

full_name: Begoña Mellado

given: Begoña

family: Varlamov

full_name: Sergey Varlamov

given: Sergey

family: Joshi

full_name: Monika Joshi

given: Monika

family: Duran

full_name: Ignacio Duran

given: Ignacio

family: Tagawa

full_name: Scott T. Tagawa

given: Scott T.

family: Zakharia

full_name: Yousef Zakharia

given: Yousef

family: Zhong

full_name: Bob Zhong

given: Bob

family: Stuyckens

full_name: Kim Stuyckens

given: Kim

family: Santiago-Walker

full_name: Ademi Santiago-Walker

given: Ademi

family: De Porre

full_name: Peter De Porre

given: Peter

family: O’Hagan

full_name: Anne O’Hagan

given: Anne

family: Avadhani

full_name: Anjali Avadhani

given: Anjali

family: Siefker-Radtke

full_name: Arlene O. Siefker-Radtke

given: Arlene O.

journal_name: New England Journal of Medicine

evidence: open (via free article)

location_country:
Italy
Austria
India
Germany
France
Israel
Romania
Belgium
Russian Federation
Spain
Turkey
Moldova, Republic of
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: The University of Iowa - Division of Hematology, Oncology and Blood & Marrow Transplantation

location_facility: Vivantes Klinikum Am Urban, Abt. fur Kardiologie

location_facility: Bhaktivedanta Hospital & Research Institute

location_facility: Chungnam National University Hospital - Dept. of Internal Medicine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Spitalul Clinic Municipal De Urgenta Timisoara; Sectia Oncologie

location_facility: Institutul Oncologic ''Prof Dr. Ion Chiricuta'' Cluj-Napoca

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: Kliniken Nordoberpfalz, Klinik für Urologie

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Oncologia Medica Azienda Sanitaria Ospedaliera San Luigi Gonzaga

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Scientific Research Institute of Urology

location_facility: Georg-August-Universitaet Goettingen - Innere Medizin - Haematologie, Onkologie

location_facility: Medizinische Hochschule Hannover;Klinik f. Urologie u. Urologische Onkologie

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Caritas Krankenhaus St. Josef - Innere Medizin II

location_facility: University of California - Davis Medical Center

location_facility: University hospital Muenster, Dpt. of Urology

location_facility: Spitalul Clinic de Urologie Prof. Dr. Theodor Burghele

location_facility: Cedars Sinai Medical Center - Pediatric Infectious Disease

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Waldkrankenhaus St. Marien -Urologische Universitätsklinik-

location_facility: Post Graduate Institute of Medical Education & Research (PGIMER)

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Sourasky Medical Center, Tel Aviv Sourasky Med Ctr

location_facility: UOC di Oncologia Medica Università Cattolica del Sacro Cuore Policlinico Universitario A. Gemelli

location_facility: Istituto Clinico Humanitas UO di Emodinamica e Cradiologia Interventistica

location_facility: Oncologia Medica-Città Della Salute E Della Scienza Di Torino

location_facility: Leningradski Regional Oncological Dispensary

location_facility: Georgetown Univ. Medical Center - Lombardi Cancer Center

location_facility: Weill Medical College of Cornell University

location_facility: Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma

location_facility: Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst

location_facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Penn State Milton S. Hershey Medical Ctr.

location_facility: Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

location_facility: Oncologia Medica A - Ist Naz Tumori G Pascale


title: Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

summary: An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rosencher N, Samama CM, Feuring M, Brueckmann M, Kleine E, Clemens A, Frostick S. Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting. Thromb J. 2016 Apr 1;14:8. doi: 10.1186/s12959-016-0082-4. eCollection 2016.

family: Rosencher

full_name: Nadia Rosencher

given: Nadia

sequence: first

family: Samama

full_name: Charles M. Samama

given: Charles M.

sequence: additional

family: Feuring

full_name: Martin Feuring

given: Martin

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Kleine

full_name: Eva Kleine

given: Eva

family: Clemens

full_name: Andreas Clemens

given: Andreas

family: Frostick

full_name: Simon Frostick

given: Simon

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Thrombosis Journal

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Sweden
France
Poland
Ireland
Spain
Germany
United Kingdom

location_facility: 1160.85.4305 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3311A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04931 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3305A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4803 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3315A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04941 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04403 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04917 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3321A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04947 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04923 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04901 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03907 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03905 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04903 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4312 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4304 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3322A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3310A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3406 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3319A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04948 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3407 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04404 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04909 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04913 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04914 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04943 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4301 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3302A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4303 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04918 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04916 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04906 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3308A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04952 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04926 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.35301 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3323A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04936 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04922 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03906 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3404 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04915 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04949 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4604 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03914 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04944 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04939 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04921 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3325A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04927 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3317A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4302 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4310 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3304A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04924 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04940 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04920 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4804 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04907 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3301A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04932 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3303A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3320A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3331A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04946 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04406 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3405 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3334A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03911 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04929 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3401 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3313A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4806 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04405 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4805 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04912 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04902 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4601 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3324A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4802 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04928 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4309 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3318A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03910 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3314A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04905 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3333A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4311 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03909 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4308 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4307 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.03913 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04938 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04933 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3307A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04910 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.4603 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3309A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04935 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04930 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04402 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04401 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04904 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3402 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04934 Boehringer Ingelheim Investigational Site

location_facility: 1160.85.3306A Boehringer Ingelheim Investigational Site

location_facility: 1160.85.04945 Boehringer Ingelheim Investigational Site

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blümle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8:CD012548. doi: 10.1002/14651858.CD012548.pub2. Review.

name: Department of Urology and Paediatric Urology; University Hospital Ulm; Ulm Germany

name: UroEvidence@Deutsche Gesellschaft für Urologie; Berlin Germany

family: Zengerling

full_name: Friedemann Zengerling

given: Friedemann

family: Jakob

full_name: Joachim J Jakob

given: Joachim J

family: Schmidt

full_name: Stefanie Schmidt

given: Stefanie

name: Institute for Evidence in Medicine; Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; Freiburg Germany

name: Cochrane Germany; Cochrane Germany Foundation; Freiburg Germany

family: Meerpohl

full_name: Joerg J Meerpohl

given: Joerg J

family: Blümle

full_name: Anette Blümle

given: Anette

family: Schmucker

full_name: Christine Schmucker

given: Christine

name: Institute of Epidemiology and Medical Biometry; Ulm University; Ulm Germany

family: Mayer

full_name: Benjamin Mayer

given: Benjamin

name: Department of Urology and Pediatric Urology; University Hospital Erlangen; Erlangen Germany

name: Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN); Erlangen Germany

family: Kunath

full_name: Frank Kunath

given: Frank

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.

family: Mason

full_name: M. Mason

given: M.

family: Maldonado Pijoan

full_name: X. Maldonado Pijoan

given: X.

family: Steidle

full_name: C. Steidle

given: C.

family: Guerif

full_name: S. Guerif

given: S.

family: Wiegel

full_name: T. Wiegel

given: T.

family: van der Meulen

full_name: E. van der Meulen

given: E.

family: Bergqvist

full_name: P.B.F. Bergqvist

family: Khoo

full_name: V. Khoo

given: V.

journal_name: Clinical Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Neoadjuvant Androgen Deprivation Therapy for Prostate Volume Reduction, Lower Urinary Tract Symptom Relief and Quality of Life Improvement in Men with Intermediate- to High-risk Prostate Cancer: A Randomised Non-inferiority Trial of Degarelix versus Goserelin plus Bicalutamide

design_allocation: Randomized

intervention_type: Drug

study_type: Interventional

lead_sponsor: Ferring Pharmaceuticals

primary_purpose: Treatment

location_country:
United States
Netherlands
France
Greece
Spain
Germany
United Kingdom

location_facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

location_facility: Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie

location_facility: Hôpital Saint Louis, Radiotherapy Departement

location_facility: University General Hospital of Loannina, Medical School

location_facility: Northern Centre for Cancer Treatment, Newcastle General Hospital

location_facility: General University Hospital of Alexandroupolis

location_facility: Oncology Royal United Hospital Bath NHS Trust

location_facility: DCT -Celebration, LLC dba Discovery Clinical Trials

location_facility: Albert Schweitzer Ziekenhuis, Ioc., Dordwijk

location_facility: Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre

location_facility: CRLC Val d'Aurelle Oncology Radiotherapy

location_facility: General Hospital of Athens, "Sismanogleio", University of Athens, Marouse

location_facility: Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie

location_facility: Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)

summary: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.


ReferenceCitation: Al-Sawaf O, Zhang C, Tandon M, Sinha A, Fink AM, Robrecht S, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Dû K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Tausch E, Schary W, Ritgen M, Wendtner CM, Kreuzer KA, Eichhorst B, Stilgenbauer S, Hallek M, Fischer K. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1188-1200. doi: 10.1016/S1470-2045(20)30443-5.

family: Al-Sawaf

full_name: Othman Al-Sawaf

given: Othman

family: Zhang

full_name: Can Zhang

given: Can

family: Tandon

full_name: Maneesh Tandon

given: Maneesh

family: Sinha

full_name: Arijit Sinha

given: Arijit

family: Fink

full_name: Anna-Maria Fink

given: Anna-Maria

family: Robrecht

full_name: Sandra Robrecht

given: Sandra

family: Samoylova

full_name: Olga Samoylova

given: Olga

family: Liberati

full_name: Anna M Liberati

given: Anna M

family: Pinilla-Ibarz

full_name: Javier Pinilla-Ibarz

given: Javier

family: Opat

full_name: Stephen Opat

given: Stephen

family: Sivcheva

full_name: Liliya Sivcheva

given: Liliya

family: Le Dû

full_name: Katell Le Dû

given: Katell

family: Fogliatto

full_name: Laura M Fogliatto

given: Laura M

family: Niemann

full_name: Carsten U Niemann

given: Carsten U

family: Weinkove

full_name: Robert Weinkove

given: Robert

family: Robinson

full_name: Sue Robinson

given: Sue

family: Kipps

full_name: Thomas J Kipps

given: Thomas J

family: Tausch

full_name: Eugen Tausch

given: Eugen

family: Schary

full_name: William Schary

given: William

family: Ritgen

full_name: Matthias Ritgen

given: Matthias

family: Wendtner

full_name: Clemens-Martin Wendtner

given: Clemens-Martin

family: Kreuzer

full_name: Karl-Anton Kreuzer

given: Karl-Anton

family: Eichhorst

full_name: Barbara Eichhorst

given: Barbara

family: Stilgenbauer

full_name: Stephan Stilgenbauer

given: Stephan

family: Hallek

full_name: Michael Hallek

given: Michael

ReferenceCitation: Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, Robrecht S, Warburton S, Humphrey K, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Dû K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Boettcher S, Tausch E, Humerickhouse R, Eichhorst B, Wendtner CM, Langerak AW, Kreuzer KA, Ritgen M, Goede V, Stilgenbauer S, Mobasher M, Hallek M. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019 Jun 6;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. Epub 2019 Jun 4.

name: From Department I of Internal Medicine, Center for Integrated Oncology Aachen–Bonn–Cologne–Duesseldorf, University Hospital Cologne and University of Cologne (K.F., O.A.-S., J.B., A.-M.F., S. Robrecht, B.E., K.-A.K., M.H.), the Oncogeriatric Unit, Department of Geriatric Medicine, St. Marien Hospital (V.G.), CECAD (Center of Excellence on Cellular Stress Responses in Aging-Associated Diseases) (M.H.), Center for Molecular Medicine Cologne (M.H.), Cologne, Department III of Internal Medicine, University...

location_country:
Romania
Australia
Russian Federation
Denmark
Croatia
France
Poland
Argentina
Canada
Switzerland
Bulgaria
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
New Zealand
Spain
Estonia

location_facility: Arcispedale S. Anna; Sezione Di Ematologia

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu; Klinika Hematologii

location_facility: University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology

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

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia

location_facility: Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie

location_facility: SBEI of HPE "Bashkir State Medical University" of MoH RF

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Western General Hospital; Department of Haematology

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Hôpital Saint Eloi; Service d'Hématologie et Oncologie Clinique - Recherche Clinique

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte

location_facility: Moscow State Budgetary Healthcare Institution

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

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

location_facility: North Estonia medical Centre; Hematology

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

location_facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Hopital Pontchaillou; Hematologie Clinique

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Hematologii z Pododdziałem Chorob Naczyn

location_facility: MHAT Hristo Botev; First Internal Department

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

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie

location_facility: Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: Ashford Cancer Centre Research; Internal Medicine/Medical Oncology

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: University Hospital Sv.Georgi Clnic of Hematology; Hematology

location_facility: Universitätsklinikum Essen; Klinik für Hämatologie

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia

location_facility: München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

location_facility: AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth

location_facility: Hanusch-Krankenhaus; Iii. Medizinische Abt.

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Wojewódzki Szpital Specjalistyczny im.MikołajaKopernika;KlinikaHematologiiUniwersytetuMedycznego

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Praxisklinik für Hämatologie und Onkologie Koblenz

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: University Hospital Merkur Clinic for Internal Medicine/ Hematology

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

title: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.


ReferenceCitation: Siddiqui MK, Smith G, St Jean P, Dawed AY, Bell S, Soto-Pedre E, Kennedy G, Carr F, Wallentin L, White H, Macphee CH, Waterworth D, Palmer CNA. Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events. Diabetologia. 2021 Sep 25. doi: 10.1007/s00125-021-05574-5. [Epub ahead of print]

family: Siddiqui

full_name: Moneeza K. Siddiqui

given: Moneeza K.

family: Smith

full_name: Gillian Smith

given: Gillian

family: St Jean

full_name: Pamela St Jean

given: Pamela

family: Dawed

full_name: Adem Y. Dawed

given: Adem Y.

family: Bell

full_name: Samira Bell

given: Samira

family: Soto-Pedre

full_name: Enrique Soto-Pedre

given: Enrique

family: Kennedy

full_name: Gwen Kennedy

given: Gwen

family: Carr

full_name: Fiona Carr

given: Fiona

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: White

full_name: Harvey White

given: Harvey

family: Macphee

full_name: Colin H. Macphee

given: Colin H.

family: Waterworth

full_name: Dawn Waterworth

given: Dawn

family: Palmer

full_name: Colin N. A. Palmer

given: Colin N. A.

journal_name: Diabetologia

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Dundee - Discovery Research Portal

repositories_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagström E, Held C, Kleber ME, Koenig W, März W, Stewart RAH, White HD, Åberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.

family: Eriksson

full_name: Niclas Eriksson

given: Niclas

family: Olszowka

full_name: Maciej Olszowka

given: Maciej

family: Grammer

full_name: Tanja B. Grammer

given: Tanja B.

family: Hagström

full_name: Emil Hagström

given: Emil

family: Held

full_name: Claes Held

given: Claes

family: Kleber

repository_institution: Uppsala University - Uppsala University Publications

repositories_institution: Uppsala University - Uppsala University Publications

ReferenceCitation: White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18.

ReferenceCitation: Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylhä A, Lindbäck J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy. J Am Heart Assoc. 2020 May 18;9(10):e015258. doi: 10.1161/JAHA.119.015258. Epub 2020 May 7.

name: Department of Medical Sciences Uppsala University Uppsala Sweden

name: Uppsala Clinical Research Center Uppsala Sweden

name: Medical Center Duke University Durham NC

name: Deutsches Herzzentrum München Technische Universität München München Germany and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance Munich Germany

name: Institute of Epidemiology and Medical Biometry University of Ulm Germany

name: N Green Lane Cardiovascular Service Auckland City Hospital and University of Auckland New Zealand

name: Finnish Cardiovascular Research Center University of Tampere Finland

name: Finnish Clinical Biobank Tampere Tampere University Hospital Tampere Finland

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Prediction of Residual Risk by Ceramide‐Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy

ReferenceCitation: Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and Lifestyle Risk Factors and Cognitive Function in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2019 Apr 2;8(7):e010641. doi: 10.1161/JAHA.118.010641.

name: Green Lane Cardiovascular Service Auckland City Hospital Auckland New Zealand

name: Department of Medical Sciences Cardiology Uppsala University Uppsala Sweden

name: Uppsala Clinical Research Center (UCR) Uppsala Sweden

name: Metabolic Pathways and Cardiovascular Medicine Delivery Unit GlaxoSmithKline Research and Development Collegeville PA

name: Department of Genetics GlaxoSmithKline Medicines Research Centre Upper Merion Philadelphia PA

name: Duke Clinical Research Institute Durham NC

name: Canadian VIGOUR Centre University of Alberta Edmonton Canada

ReferenceCitation: Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Östlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10). pii: e005077. doi: 10.1161/JAHA.116.005077.

name: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden

name: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

name: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand

name: Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland

name: Cardiovascular Division, Brigham and Women's Hospital, Boston, MA

name: Department of Medicine, NYU Langone Medical Center, New York, NY

name: Department of Internal Medicine II‐Cardiology, University of Ulm Medical Center, Ulm, Germany

name: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany

name: DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany

name: Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden

name: Département Hospitalo‐Universitaire FIRE, AP‐HP, Hôpital Bichat, Paris, France

name: Paris Diderot University Sorbonne Paris Cité, Paris, France

name: NHLI Imperial College, ICMS, Royal Brompton Hospital, London, United Kingdom

name: FACT (French Alliance for Cardiovascular Trials), an F‐CRIN network, INSERM U1148, Paris, France

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, Collegeville, PA

name: Henry Ford Heart and Vascular Institute, Detroit, MI

name: on behalf of the STABILITY Investigators

title: Inflammatory Biomarkers Interleukin‐6 and C‐Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial

ReferenceCitation: Hagström E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, López-Sendón J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23.

name: Department of Medical Sciences; Uppsala University; Uppsala Sweden

name: Uppsala Clinical Research Center; Uppsala University; Uppsala Sweden

name: Department of Women′s and Children′s Health; Uppsala University; Uppsala Sweden

name: Duke Clinical Research Institute; Duke University Medical Center; Durham NC USA

name: Hospital Universitario La Paz; Instituto de investigacion IdiPaz; Paseo de la Castellana; Madrid Spain

name: Department of Medicine; PJ Safarik University; Kosice Slovakia

name: Metabolic Pathways and Cardiovascular Therapeutic Area; GlaxoSmithKline, Collegeville PA USA

name: Department of Internal Medicine; College of Medicine; University of the Philippines-Manila; Manila Philippines

name: Green Lane Cardiovascular Service; Auckland New Zealand

name: University of Auckland; Auckland New Zealand

ReferenceCitation: Guimarães PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagström E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9). pii: e006695. doi: 10.1161/JAHA.117.006695.

name: Duke Clinical Research Institute, Durham, NC

name: Duke University Medical Center, Durham, NC

name: Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

name: Department of Medicine and Population Health Research Institute, McMaster University, Hamilton, ON, Canada

name: Green Lane Cardiovascular Service, Auckland City Hospital and University of Auckland, Auckland, New Zealand

name: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania

name: Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, INSERM U‐970 and Université Paris Descartes, Paris, France

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Stewart RAH, Hagström E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, López-Sendón JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8). pii: e006096. doi: 10.1161/JAHA.117.006096.

name: Auckland City Hospital, Auckland, New Zealand

name: Department of Medical Sciences Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

name: Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada

name: South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, Australia

name: DZHK (German Centre for Cardiovascular Research) partner site Munich Heart Alliance, Munich, Germany

name: Hospital Universitario La Paz IdiPaz, Madrid, Spain

name: Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, King of Prussia, PA

name: San Jose Satelite Hospital, Naucalpan de Juárez, Mexico

name: Punjab Medical Center Jail road Lahore, Punjab, Pakistan

name: Département Hospitalo‐Universitaire FIRE, AP‐HP Hôpital Bichat, Paris, France

name: Sorbonne Paris Cité Diderot University, Paris, France

name: FACT (French Alliance for Cardiovascular Trials), an F‐CRIN Network, INSERM U1148, Paris, France

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

title: Self‐Reported Health and Outcomes in Patients With Stable Coronary Heart Disease

ReferenceCitation: Lindholm D, Lindbäck J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagström E, Held C, Koenig W, Östlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, März W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Vedin O, Hagström E, Östlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17.

repository_institution: University of East Anglia - UEA Digital Repository

repositories_institution: University of East Anglia - UEA Digital Repository

ReferenceCitation: Hagström E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Östlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3.

name: Uppsala Clinical Research Center (UCR), Uppsala University, Uppsala, Sweden

name: Green Lane Cardiovascular Service, Auckland City Hospital, and University of Auckland, Auckland, New Zealand

name: Cardiovascular Division, Brigham and Women's Hospital, and Harvard Clinical Research Institute, Boston, MA, USA

name: Department of Internal Medicine II–Cardiology, University of Ulm Medical Center, Ulm, Germany

name: University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA

name: Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Paris, France

name: Paris Diderot University, Sorbonne Paris Cité, Paris, France

name: NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK

name: FACT (French Alliance for Cardiovascular Trials), an F-CRIN network, INSERM U1148, Paris, France

name: former employee of Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, King of Prussia, PA, USA

ReferenceCitation: Wallentin L, Held C, Armstrong PW, Cannon CP, Davies RY, Granger CB, Hagström E, Harrington RA, Hochman JS, Koenig W, Krug-Gourley S, Mohler ER 3rd, Siegbahn A, Tarka E, Steg PG, Stewart RA, Weiss R, Östlund O, White HD; STABILITY Investigators. Lipoprotein-Associated Phospholipase A2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2016 Jun 21;5(6). pii: e003407. doi: 10.1161/JAHA.116.003407.

name: Harvard Clinical Research Institute, Boston, MA

name: Medical Center, Duke University, Durham, NC

name: Department of Medicine, Stanford University, Stanford, CA

name: DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

name: Former Employee of Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, King of Prussia, PA

name: FACT (French Alliance for Cardiovascular Trials), Paris, France

name: DHU FIRE, Université Paris‐Diderot, Sorbonne Paris‐Cité, Paris, France

name: Hôpital Bichat, INSERUM U‐1148, Paris, France

name: NHLI, ICMS, Imperial College, Royal Brompton Hospital, London, UK

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

title: Lipoprotein‐Associated Phospholipase A 2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease

ReferenceCitation: Hijazi Z, Lindbäck J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.

ReferenceCitation: Vedin O, Hagström E, Budaj A, Denchev S, Harrington RA, Koenig W, Soffer J, Sritara P, Stebbins A, Stewart RH, Swart HP, Viigimaa M, Vinereanu D, Wallentin L, White HD, Held C; STABILITY Investigators. Tooth loss is independently associated with poor outcomes in stable coronary heart disease. Eur J Prev Cardiol. 2016 May;23(8):839-46. doi: 10.1177/2047487315621978. Epub 2015 Dec 16.

name: Clinic of Cardiology, Medical Institute of Ministry of Interior, Sofia, Bulgaria

name: Department of Medicine, Stanford University, Stanford, CA, USA

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, Pennsylvania, USA

name: Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

name: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

name: Department of Cardioresearch, Antonius Ziekenhuis Sneek, The Netherlands

name: Tallinn University of Technology, North Estonia Medical Centre, Tallinn, Estonia

name: University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania

journal_name: European Journal of Preventive Cardiology

title: Tooth loss is independently associated with poor outcomes in stable coronary heart disease

ReferenceCitation: Vedin O, Hagström E, Gallup D, Neely ML, Stewart R, Koenig W, Budaj A, Sritara P, Wallentin L, White HD, Held C. Periodontal disease in patients with chronic coronary heart disease: Prevalence and association with cardiovascular risk factors. Eur J Prev Cardiol. 2015 Jun;22(6):771-8. doi: 10.1177/2047487314530660. Epub 2014 Apr 10.

name: Department of Medical Sciences, Uppsala University, Sweden

name: Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand

name: University of Ulm Medical Centre, Germany

name: Postgraduate Medical School, Grochowski Hospital, Poland

name: Ramathibodi Hospital, Mahidol University, Thailand

ReferenceCitation: STABILITY Investigators, White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, López-Sendón J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

title: Darapladib for Preventing Ischemic Events in Stable Coronary Heart Disease

ReferenceCitation: Vedin O, Hagström E, Stewart R, Brown R, Krug-Gourley S, Davies R, Wallentin L, White H, Held C. Secondary prevention and risk factor target achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2013 Aug;20(4):678-85. doi: 10.1177/2047487312444995. Epub 2012 Apr 10.

name: Department of Medical Sciences, Uppsala University, Uppsala, Sweden

name: GlaxoSmithKline, Research Triangle Park, North Carolina, USA

name: GlaxoSmithKline, Upper Merion, Pennsylvania, USA

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
India
Pakistan
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
New Zealand
Spain
Estonia

title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.


ReferenceCitation: Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c ≤ 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.

family: Lv

full_name: Qian Lv

given: Qian

family: Shen

full_name: Jie Shen

given: Jie

family: Miao

full_name: Lin Miao

given: Lin

family: Ye

full_name: Binqi Ye

given: Binqi

family: Schepers

full_name: Cornelia Schepers

given: Cornelia

family: Plat

full_name: Arian Plat

given: Arian

family: Shi

full_name: Yongquan Shi

given: Yongquan

journal_name: Diabetes Therapy

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

location_country:
Sweden
India
Mexico
Netherlands
Croatia
France
Lithuania
Tunisia
Romania
Russian Federation
Estonia
Germany
Canada
Ukraine

location_facility: 1218.46.3306C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2161A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91012 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91013 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91018 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2163A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91017 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31011 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91014 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91016 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2163B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38505 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2162A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31015 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37202 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31012 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31016 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38502 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38503 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38501 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91015 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37203 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38504 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2161B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37201 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304H Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91019 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38506 Boehringer Ingelheim Investigational Site

title: A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control

summary: The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks


ReferenceType: background

ReferenceCitation: Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.

ReferenceCitation: Dizier B et al. (2019) A T-helper 1/interferon-ϒ gene signature is prognostic in the adjuvant setting of resectable high-risk melanoma but not in non-small cell lung cancer. Clin Cancer Res. pii: clincanres.3717.2018. doi: 10.1158/1078-0432.CCR-18-3717. [Epub ahead of print].

status: Terminated

study_start_date_type: Actual

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

lead_sponsor: GlaxoSmithKline

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

acronym: MAGE3-AS15-MEL-005 (ADJ)

ipd_sharing: Yes

title: GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

summary:
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

status_simplified: Unknown


ReferenceCitation: Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1701-1710. doi: 10.2215/CJN.01380219. Epub 2019 Aug 16.

family: Locatelli

full_name: Francesco Locatelli

given: Francesco

family: Hannedouche

full_name: Thierry Hannedouche

given: Thierry

family: Fishbane

full_name: Steven Fishbane

given: Steven

family: Morgan

full_name: Zoe Morgan

given: Zoe

family: Oguey

full_name: Delphine Oguey

given: Delphine

family: White

full_name: William B. White

given: William B.

journal_name: Clinical Journal of the American Society of Nephrology

oa_colors: green other

evidence: open (via free pdf)

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

lead_sponsor: Hoffmann-La Roche

location_country:
Malaysia
Greece
Belgium
Australia
Russian Federation
Taiwan
Croatia
France
Lithuania
Panama
Poland
Thailand
Argentina
Korea, Republic of
Sweden
Philippines
Singapore
Germany
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

acronym: Post Authorization Safety Study (PASS)

location_facility: Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn

location_facility: Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie

location_facility: Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi

location_facility: Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi

location_facility: Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia

location_facility: Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi

location_facility: A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi

location_facility: The Ipswich Hospital Nhs Trust; The Renal Unit

location_facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

location_facility: Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi

location_facility: S.P. Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi

location_facility: Buddhachinaraj Hospital Renal Division; Dept of Medicine

location_facility: Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi

location_facility: ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS

location_facility: Monash Medical Centre; Renal Transplant Unit

location_facility: Hospital de Navarra; Servicio de Nefrologia

location_facility: Samsung Medical Center; Nephrology Department

location_facility: National Taiwan Uni Hospital; Nephrology Dept

location_facility: Chang Gung Medical Fundation Kaohsiung Branch; Nephrology

location_facility: Hospital das Clinicas - FMUSP; Nefrologia

location_facility: UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV

location_facility: Leicester General Hospital; Dept of Nephrology

location_facility: Cukurova University School of Medicine; Nefrology Department

location_facility: Ospedale Civile; Divisione de Nefrologia E Dialisi

location_facility: Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny

location_facility: Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: Klinicki Bolnicki Centar Zagreb; Dialysis

location_facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny

location_facility: Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu

location_facility: Univeristy Hospital of Larissa; Nephrology

location_facility: Hospital Infanta Sofia; Servico de Nefrologia

location_facility: P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach

location_facility: Uppsala University Hospital; Department of Internal Medicine, Nephrology Section

location_facility: National University Hospital; Dept of Medicine

location_facility: King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine

location_facility: Stacja Dializ NZOZ Centrum Medyczne MEDYK

location_facility: KFH Nierenzentrum Bad Hersfeld; Nephrologie

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Hospital Kuala Lumpur; Department of Medicine

location_facility: Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi

location_facility: A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi

location_facility: Hospital de Galdakano; Servicio de Nefrologia

location_facility: Tan Tock Seng Hospital; Department of Renal Medicine

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: Vilnius University Hospital Santariskiu Clinic, Nephrology Center

location_facility: Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.

location_facility: Hospital Txagorritxu; Servicio de Nefrologia

location_facility: Hospital del Mar; Servicio de Nefrologia

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum

location_facility: Seoul National Uni Hospital; Internal Medicine

location_facility: Uni Hospital of Alexandroupoli; Nephrology Dept.

location_facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico

location_facility: Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii

location_facility: University Hospital of Wales; Institute of Nephrology

location_facility: Baskent University Hospital; Transplantation

location_facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse

location_facility: ASST LARIANA; Divisione di Nefrologia e Dialisi

location_facility: Royal Devon & Exeter Hospital; Dept of Nephrology

location_facility: St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"

location_facility: Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi

location_facility: Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi

location_facility: General Hospital Karlovac; Dept of Haemodialysis

location_facility: Hospital de Cruces; Servicio de Nefrologia

location_facility: Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Nemocnice Strahov; Interni Oddeleni-Strahov

location_facility: Nephrologische Schwerpunktpraxis; Hamburg Barmbek

location_facility: Clinical Hospital Osijek; Dept of Haemodialysis

location_facility: Clinique Lambert; Service de Néphrologie dialyse

location_facility: Service de Nephrologie & D'Immunologie; Clinique

location_facility: Clinical Center Voivodina; Clinic for Immunology and Nephrology

location_facility: Royal Free & University College Medical School; Centre for Nephrology

location_facility: Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie

location_facility: Launceston General Hospital; Diabetes and Renal Research Unit

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

location_facility: Gold Coast Hospital Department of Pharmacology & Therapeutics

location_facility: Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal

location_facility: Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division

location_facility: Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice

location_facility: Hospital Ramon y Cajal; Servicio de Nefrologia

location_facility: General Hospital Josip Bencevic; Department of Haemodialysis

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV

location_facility: Singapore General Hospital; Renal Medicine

location_facility: Clinical Center Nis; Clinic for Nephrology and Hemodialysis

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse

location_facility: Hospital Severo Ochoa; Servicio de Nefrologia

location_facility: Ospedale Civile; Servizio Di Nefrologia E Dialisi

location_facility: Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie

location_facility: Clinical Hospital Center Rijeka; Dialysis

location_facility: Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle

location_facility: Royal Preston Hospital; Department of Renal Medicine

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

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Nefrologia

location_facility: Salford Royal Foundation Trust; Department Of Nephrology

location_facility: Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse

location_facility: ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi

location_facility: Hospital Univ. Pedro Ernesto - Hupe; Nefrologia

location_facility: A.O. Universitaria S. Martino Di Genova; Nefrologia

location_facility: Derriford Hospital; Department Of Renal Medicine

location_facility: Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych

location_facility: Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen

location_facility: Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst

location_facility: University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology

location_facility: DaVita Clinical Research Deutschland GmbH

location_facility: Hospital de Basurto; Servicio de Nefrologia

location_facility: NZOZ Stacja Dializ Hand-Prod w Limanowej

location_facility: Clinica de Medicina Interna e Nefrologia (CMIN)

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".

location_facility: Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12

location_facility: University Malaya Medical Centre; Division of Nephrology, Department of Medicine

location_facility: Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse

location_facility: National Kidney and Transplant Institute

location_facility: Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi

location_facility: Universita' Di Tor Vergata; Clinica Nefrologia Dialisi

location_facility: NZOZ Stacja Dializ Hand-Prod w Gorlicach

location_facility: A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

location_facility: Uni Hospital of Ioannina; Nephrology Dept.

location_facility: Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi

location_facility: Hopital Rangueil; Nephrologie Hemodialyse

title: A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

summary: This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.