title: A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

summary: This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Wolinsky JS, Arnold DL, Brochet B, Hartung HP, Montalban X, Naismith RT, Manfrini M, Overell J, Koendgen H, Sauter A, Bennett I, Hubeaux S, Kappos L, Hauser SL. Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):998-1009. doi: 10.1016/S1474-4422(20)30342-2. Epub 2020 Oct 29. Erratum in: Lancet Neurol. 2020 Nov 17;:.

family: Wolinsky

full_name: Jerry S Wolinsky

given: Jerry S

family: Arnold

full_name: Douglas L Arnold

given: Douglas L

family: Brochet

full_name: Bruno Brochet

given: Bruno

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Montalban

full_name: Xavier Montalban

given: Xavier

family: Naismith

full_name: Robert T Naismith

given: Robert T

family: Manfrini

full_name: Marianna Manfrini

given: Marianna

family: Overell

full_name: James Overell

family: Koendgen

full_name: Harold Koendgen

given: Harold

family: Sauter

full_name: Annette Sauter

given: Annette

family: Bennett

full_name: Iain Bennett

given: Iain

family: Hubeaux

full_name: Stanislas Hubeaux

given: Stanislas

family: Hauser

full_name: Stephen L Hauser

given: Stephen L

journal_name: The Lancet Neurology

ReferenceCitation: Fox EJ, Markowitz C, Applebee A, Montalban X, Wolinsky JS, Belachew S, Fiore D, Pei J, Musch B, Giovannoni G. Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial. Mult Scler. 2018 Dec;24(14):1862-1870. doi: 10.1177/1352458518808189. Epub 2018 Nov 12.

name: Central Texas Neurology Consultants and Dell Medical School, The University of Texas at Austin, Round Rock, TX, USA

family: Fox

full_name: Edward J Fox

given: Edward J

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

family: Markowitz

full_name: Clyde Markowitz

given: Clyde

name: Department of Neurology, St. Peter’s Health Partners, Albany, NY, USA

family: Applebee

full_name: Angela Applebee

given: Angela

name: Division of Neurology, St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada/ Department of Neurology/Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Hospital Universitari Vall d’Hebron, Barcelona, Spain

name: McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

family: Belachew

full_name: Shibeshih Belachew

given: Shibeshih

name: Genentech, Inc., South San Francisco, CA, USA

family: Fiore

name: Department of Neurology, Queen Mary University of London, London, UK

ReferenceCitation: Wolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C, Deol-Bhullar G, Garren H, Chin P, Belachew S, Kappos L. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018 Oct;84(4):527-536. doi: 10.1002/ana.25313.

name: McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth); Houston TX

name: Division of Neurology; University of Toronto; Toronto ON Canada

name: Vall d'Hebron University Hospital; Barcelona Spain

name: University of California; San Francisco, San Francisco CA

name: Queen Mary University of London; London United Kingdom

name: University of Lille, CHU Lille, LIRIC-INSERM U995; Lille France

name: F. Hoffmann-La Roche Ltd; Basel Switzerland

name: University Hospital Basel, University of Basel; Basel Switzerland

repository_institution: California Digital Library - eScholarship

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.

repository_institution: Queen Mary University of London - Queen Mary Research Online

repositories_institution: Queen Mary University of London - Queen Mary Research Online

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Ukraine
Uruguay
France
Poland
Lithuania
Norway
Canada
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research

location_facility: Vero Beach Neurology and Research Institute

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

location_facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: University of New Mexico; MS Specialty Clinic

location_facility: Indiana University Medical Center; Department of Neurology

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Michigan Institute for Neurological Disorders

location_facility: Heinrich Heine Universität Düsseldorf; Neurologische Klinik

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)

location_facility: Uni of British Columbia Hospital; Ms Clinical Research Group

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

location_facility: Research Medical Complex "Vashe Zdorovie"; Neurology Department

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny

location_facility: Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro

location_facility: Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

location_facility: Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology

location_facility: Timisoara Emergency County Clinical Hospital

location_facility: Universitätsklinikum Gießen und Marburg GmbH; Neurologie

location_facility: Washington University School of Medicine; Department of Neurology

location_facility: Krajska zdravotni, a. s. - Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Trustees of the University of Pennsylvania; Neurology

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Walton Center For Neurology & Neurosurgery; Clinical Trials Unit

location_facility: Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología

location_facility: Swedish Neuroscience Institute; Multiple Sclerosis Center

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Uni Hospital Queens Medical Centre; Neurology

location_facility: Univ of CA San Francisco; Department of Neurology

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Medical Center Ziv Safed; Neurology Department

location_facility: Henry Ford Health System; Neurology & Neurosurgery

location_facility: Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Charité - Universitätsmedizin Berlin; Klinik für Neurologie

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Instituto Nacional de Neurologia y Neurocirugia

location_facility: Dnipropetrovsk State Medical Academy; Dept of Neurology

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic

location_facility: Groupe Hospitalo-Universitaire Caremeau; Service Neurologie

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii

location_facility: University of Colorado; Anschutz Medical Campus Department of Neurology

location_facility: Bukovinian Medical State University; Department of Neurology

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Centro de Estudios Clinicos y Espec. Med. SC

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Hadassah University Hospital Ein Kerem; Neurology Department

location_facility: Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö

location_facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Weill Medical College of Cornell University; Judith Jaffe MS Ctr

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Rabin Medical Center; Multiple Sclerosis Clinic

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie

location_facility: Turku University Central Hospital; Pharmacy

location_facility: Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

location_facility: Klinikum rechts der Isar der TU München; Neurologische Klinik und Poliklinik

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Wayne State University; Department of Neurology

location_facility: Oklahoma Medical Research Foundation; MS Center of Excellence

location_facility: Montreal Neurological Institute and Hospital

location_facility: Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika

location_facility: Royal Victoria Infirmary; Neurology Dept.

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Hospital de Basurto; Servicio de Neurologia

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

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

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

location_facility: Klinikum Bayreuth GmbH; Neurologische Klinik

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Fakultni nemocnice Brno; Interni kardiologicka klinika

location_facility: Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3

location_facility: Lviv Regional Clinical Hospital; Department of Neurology

location_facility: University of Minnesota; Clin. Neuro Research Unit

location_facility: University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center

location_facility: Comprehensive MS Care Center at South Shore Neurologic Assoc.

location_facility: Fövárosi Önkormányzat uzsoki utcai Kórház

location_facility: Elias Emergency University Hospital Neurology Dept; Neurology Department

location_facility: Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling

location_facility: Hopital Purpan; Fédération de neurologie

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: The Ohio State University Wexner Medical Center; Department of Neurology

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: Mount Sinai School of Medicine; Neurology

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: Barzilai Medical Center; Neurology Department

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Wellington Hospital; Department of Neurology

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie


ReferenceType: derived

ReferenceCitation: Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.

name: Yale University School of Medicine  New Haven Connecticut USA

family: Inzucchi

full_name: Silvio E. Inzucchi

given: Silvio E.

sequence: first

name: Diabetes Research Centre, University of Leicester  Leicester UK

family: Davies

full_name: Melanie J. Davies

given: Melanie J.

sequence: additional

family: Khunti

full_name: Kamlesh Khunti

given: Kamlesh

name: Boehringer Ingelheim International GmbH  Ingelheim Germany

family: Trivedi

full_name: Prabhav Trivedi

given: Prabhav

family: George

full_name: Jyothis T. George

given: Jyothis T.

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

family: Zwiener

full_name: Isabella Zwiener

given: Isabella

name: Boehringer Ingelheim Norway KS  Asker Norway

family: Johansen

full_name: Odd Erik Johansen

given: Odd Erik

name: Institute of Cardiovascular & Medical Sciences, University of Glasgow  Glasgow UK

family: Sattar

full_name: Naveed Sattar

given: Naveed

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes, Obesity and Metabolism

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Empagliflozin treatment effects across categories of baseline HbA1c , body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes

ReferenceCitation: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

family: Cherney

full_name: David Cherney

given: David

family: Lund

full_name: Søren S. Lund

given: Søren S.

family: Perkins

full_name: Bruce A. Perkins

given: Bruce A.

family: Groop

full_name: Per-Henrik Groop

given: Per-Henrik

family: Cooper

full_name: Mark E. Cooper

given: Mark E.

family: Kaspers

full_name: Stefan Kaspers

given: Stefan

family: Pfarr

full_name: Egon Pfarr

given: Egon

family: Woerle

full_name: Hans J. Woerle

given: Hans J.

family: von Eynatten

full_name: Maximilian von Eynatten

given: Maximilian

journal_name: Diabetologia

evidence: open (via free pdf)

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Häring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.

name: on behalf of the EMPA-REG METSU Trial Investigators

title: Empagliflozin as Add-on to Metformin Plus Sulfonylurea in Patients With Type 2 Diabetes: A 24-week, randomized, double-blind, placebo-controlled trial

location_country:
United States
India
Mexico
France
Korea, Republic of
Slovakia
China
Turkey
Germany
Slovenia
Canada
Taiwan

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location_facility: 1245.23.86042 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86038 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86032 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20036 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88021 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33045 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20022 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86049 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86051 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33020 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10123 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86036 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20023 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20035 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91101 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10127 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10143 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20040 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86043 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86041 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10156 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10106 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20028 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20037 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20029 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10148 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33019 Boehringer Ingelheim Investigational Site

title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.


title: Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI

acronym: GAINED

summary:
This study is designed to investigate:

the interest of a new monoclonal antibody (GA101)versus rituximab
the interest of PET to identify early responders

Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm.

The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Jullien M, Tessoulin B, Ghesquières H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Villemagne B, Gressin R, Bouabdallah K, Haioun C, Damaj G, Fornecker LM, Schiano De Colella JM, Feugier P, Hermine O, Cartron G, Bonnet C, André M, Bailly C, Casasnovas RO, Le Gouill S. Deep-Learning Assessed Muscular Hypodensity Independently Predicts Mortality in DLBCL Patients Younger Than 60 Years. Cancers (Basel). 2021 Sep 7;13(18). pii: 4503. doi: 10.3390/cancers13184503.

family: Jullien

full_name: Maxime Jullien

given: Maxime

family: Tessoulin

full_name: Benoit Tessoulin

given: Benoit

family: Ghesquières

full_name: Hervé Ghesquières

given: Hervé

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Tilly

full_name: Hervé Tilly

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Lamy

full_name: Thierry Lamy

given: Thierry

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Villemagne

full_name: Bruno Villemagne

given: Bruno

family: Gressin

full_name: Rémy Gressin

given: Rémy

family: Bouabdallah

full_name: Kamal Bouabdallah

given: Kamal

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Fornecker

full_name: Luc-Matthieu Fornecker

given: Luc-Matthieu

family: Schiano De Colella

full_name: Jean-Marc Schiano De Colella

given: Jean-Marc

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Hermine

full_name: Olivier Hermine

given: Olivier

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Bonnet

full_name: Christophe Bonnet

given: Christophe

family: André

full_name: Marc André

given: Marc

family: Bailly

full_name: Clément Bailly

given: Clément

family: Casasnovas

full_name: René-Olivier Casasnovas

given: René-Olivier

ReferenceCitation: Le Gouill S, Ghesquières H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Maisonneuve H, Gressin R, Bouhabdallah K, Haioun C, Damaj G, Fornecker L, Bouhabdallah R, Feugier P, Sibon D, Cartron G, Bonnet C, André M, Chartier L, Ruminy P, Kraeber-Bodéré F, Bodet-Milin C, Berriolo-Riedinger A, Brière J, Jais JP, Molina TJ, Itti E, Casasnovas RO. Obinutuzumab vs rituximab for advanced DLBCL: a PET-guided and randomized phase 3 study by LYSA. Blood. 2021 Apr 29;137(17):2307-2320. doi: 10.1182/blood.2020008750.

name: Service d’Hématologie, Clinique du Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France;

name: Center for Research in Cancerology and Immunology Nantes/Angers (CRCINA), Nantes, France;

name: Nantes Excellence Trajectory (NeXT), Université de Nantes, INSERM, Nantes, France;

name: Department of Hematology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Pierre Bénite, Lyon, France;

name: Service d’Hématologie, Institut Universitaire du Cancer (IUC) Toulouse Oncopole, Toulouse, France;

name: Department of Hematology, CHU Lille, Université de Lille, Lille, France;

name: Équipe d’ Accueil (EA) 7365, Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Lille, France;

name: Department of Hematology, Centre Henri Becquerel, Rouen, France;

name: Department of Hematology, Gustave Roussy, Université Paris-Saclay, Villejuif, France;

name: Department of Hematology, University Hospital of Rennes, Rennes, France;

name: Department of Hematology, Hôpital Saint-Louis, Assistance Publique–Hôpitaux de Paris (AP-HP), Université Paris Diderot, Paris, France;

name: Department of Hematology, Hopital Departemental de Vendée, La Roche sur Yon, France;

name: Department of Hematology, CHU Grenoble, Grenoble, France;

name: Department of Hematology, University Hospital of Bordeaux, Bordeaux, France;

name: Department of Hematology, Hôpital H. Mondor, Creteil, France;

name: Department of Hematology, Institut d’Hématologie de Basse Normandie, Caen, France;

name: Department of Hematology, University Hospital of Strasbourg, Strasbourg, France;

name: Department of Hematology, Institut P. Calmette, Marseille, France;

name: Department of Hematology, University Hospital of Nancy, Vandoeuvre les Nancy, France;

name: Department of Hematology, Hôpital Necker, Paris, France;

name: Department of Hematology, University Hospital of Montpellier, Montpellier, France;

name: Department of Hematology, CHU Liege, Liege, Belgium;

name: Department of Hematology, CHU Université Catholique de Louvain (UCL) Namur, Yvoir, Belgium;

name: Department of Biostatistics, The Lymphoma Academic Research Organisation (LYSARC), Lyon, France;

name: INSERM U1245, Centre Henri Becquerel, Rouen, France;

name: Department of Nuclear Medicine, University Hospital of Nantes, Nantes, France;

name: Department of Nuclear Medicine, Centre Georges-François Leclerc, Dijon, France;

name: Department of Biostatistics, Hôpital Necker, University of Paris, Paris, France;

name: Institut Imagine, Unité INSERM 1163, Paris, France;

name: Department of Pathology, Hôpital Necker, University of Paris 3, Paris, France;

name: Department of Nuclear Medicine, Hôpital H. Mondor, Creteil, France;

name: Department of Hematology, University Hospital F. Mitterrand, Dijon, France; and

name: Unité Mixte de Recherche (UMR) 1231, INSERM, Dijon, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

ReferenceCitation: Blanc-Durand P, Jégou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodéré F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: AZ GROENINGE - Oncology Centre - Campus Maria's Voorzienigheid

location_facility: Clinique Saint Joseph -Hôpital de Warquignies

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: Hôpital de Bayonne - CHU de la Côte Basque


title: A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness

summary: This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Domenech C, Pastore A, Altamura AC, Bernasconi C, Corral R, Elkis H, Evans J, Malla A, Margari F, Krebs MO, Nordstroem AL, Zink M, Haro JM. Correlation of Health-Related Quality of Life in Clinically Stable Outpatients with Schizophrenia. Neuropsychiatr Dis Treat. 2019 Dec 20;15:3475-3486. doi: 10.2147/NDT.S218578. eCollection 2019.

family: Domenech

full_name: Cristina Domenech

given: Cristina

family: Pastore

full_name: Adriana Pastore

given: Adriana

family: Altamura

full_name: A Carlo Altamura

given: A Carlo

family: Bernasconi

full_name: Corrado Bernasconi

given: Corrado

family: Corral

full_name: Ricardo Corral

given: Ricardo

family: Elkis

full_name: Helio Elkis

given: Helio

family: Evans

full_name: Jonathan Evans

given: Jonathan

family: Malla

full_name: Ashok Malla

given: Ashok

family: Margari

full_name: Francesco Margari

given: Francesco

family: Krebs

full_name: Marie-Odile Krebs

given: Marie-Odile

family: Nordstroem

full_name: Anna-Lena Nordstroem

given: Anna-Lena

family: Zink

full_name: Mathias Zink

given: Mathias

family: Haro

full_name: Josep Maria Haro

given: Josep Maria

currency_apc_doaj: USD

journal_name: Neuropsychiatric Disease and Treatment

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

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

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Franklin M, Mukuria C, Mulhern B, Tran I, Brazier J, Watson S. Measuring the Burden of Schizophrenia Using Clinician and Patient-Reported Measures: An Exploratory Analysis of Construct Validity. Patient. 2019 Aug;12(4):405-417. doi: 10.1007/s40271-019-00358-x.

family: Franklin

full_name: Matthew Franklin

journal_name: The Patient - Patient-Centered Outcomes Research

repository_institution: University of Technology Sydney - Open Publications Of UTS Scholars

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Domenech C, Bernasconi C, Moneta MV, Nordstroem AL, Cristobal-Narvaez P, Vorstenbosch E, Cobo J, Ochoa S, Haro JM. Health-related quality of life associated with different symptoms in women and in men who suffer from schizophrenia. Arch Womens Ment Health. 2019 Jun;22(3):357-365. doi: 10.1007/s00737-018-0896-0. Epub 2018 Aug 7.

location_country:
Italy
Brazil
Germany
France
Argentina
Spain
Canada
United Kingdom


type: EudraCT Number

title: Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

summary: This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.

ReferenceCitation: Saad F, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Nilsson S, Miller K, Wirth M, Reeves J, Seger M, Carles J, Heidenreich A. Disease Characteristics and Completion of Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Radium-223 in an International Early Access Program. Clin Genitourin Cancer. 2019 Oct;17(5):348-355.e5. doi: 10.1016/j.clgc.2019.05.012. Epub 2019 May 31.

family: Saad

full_name: Fred Saad

given: Fred

family: Gillessen

full_name: Silke Gillessen

given: Silke

family: Heinrich

full_name: Daniel Heinrich

given: Daniel

family: Keizman

full_name: Daniel Keizman

family: O’Sullivan

full_name: Joe M. O’Sullivan

given: Joe M.

family: Nilsson

full_name: Sten Nilsson

given: Sten

family: Miller

full_name: Kurt Miller

given: Kurt

family: Wirth

full_name: Manfred Wirth

given: Manfred

family: Reeves

full_name: John Reeves

given: John

family: Seger

full_name: Monica Seger

given: Monica

family: Carles

full_name: Joan Carles

given: Joan

family: Heidenreich

full_name: Axel Heidenreich

given: Axel

journal_name: Clinical Genitourinary Cancer

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Queen's University Belfast - Research Portal

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Heidenreich A, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Carles J, Wirth M, Miller K, Reeves J, Seger M, Nilsson S, Saad F. Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program. BMC Cancer. 2019 Jan 7;19(1):12. doi: 10.1186/s12885-018-5203-y.

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

ReferenceCitation: Saad F, Carles J, Gillessen S, Heidenreich A, Heinrich D, Gratt J, Lévy J, Miller K, Nilsson S, Petrenciuc O, Tucci M, Wirth M, Federhofer J, O'Sullivan JM; Radium-223 International Early Access Program Investigators. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 Sep;17(9):1306-16. doi: 10.1016/S1470-2045(16)30173-5. Epub 2016 Jul 26.

location_country:
Italy
Sweden
Switzerland
Mexico
Netherlands
Germany
United Kingdom
Finland
France
Poland
Israel
Norway
Ireland
Belgium
Russian Federation
Spain
Denmark
Canada
Czech Republic


ReferenceCitation: Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiełło-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortés J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaër S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2. Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18.

family: Campone

full_name: Mario Campone

given: Mario

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

family: Clemons

full_name: Mark Clemons

given: Mark

family: Ito

full_name: Yoshinori Ito

given: Yoshinori

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Chia

full_name: Stephen Chia

given: Stephen

family: Jagiełło-Gruszfeld

full_name: Agnieszka Jagiełło-Gruszfeld

given: Agnieszka

family: Pistilli

full_name: Barbara Pistilli

given: Barbara

family: Tseng

full_name: Ling-Ming Tseng

given: Ling-Ming

family: Hurvitz

full_name: Sara Hurvitz

given: Sara

family: Masuda

full_name: Norikazu Masuda

given: Norikazu

family: Cortés

full_name: Javier Cortés

given: Javier

family: De Laurentiis

full_name: Michele De Laurentiis

given: Michele

family: Arteaga

full_name: Carlos L. Arteaga

given: Carlos L.

family: Jiang

full_name: Zefei Jiang

given: Zefei

family: Jonat

full_name: Walter Jonat

given: Walter

family: Le Mouhaër

full_name: Sylvie Le Mouhaër

given: Sylvie

family: Sankaran

full_name: Banu Sankaran

given: Banu

family: Bourdeau

full_name: Laurence Bourdeau

given: Laurence

family: El-Hashimy

full_name: Mona El-Hashimy

given: Mona

family: Sellami

full_name: Dalila Sellami

given: Dalila

family: Baselga

full_name: José Baselga

given: José

journal_name: European Journal of Cancer

ReferenceCitation: Baselga J, Im SA, Iwata H, Cortés J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiełło-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):904-916. doi: 10.1016/S1470-2045(17)30376-5. Epub 2017 May 30. Erratum in: Lancet Oncol. 2019 Feb;20(2):e71-e72.

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Peru
Greece
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Switzerland
Netherlands
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: University of Rochester Medical Center Univ Rochester

location_facility: Arizona Oncology Associates Dept of Oncology

location_facility: MD Anderson Cancer Center - Orlando MD Orlando

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins

location_facility: Levine Cancer Institute Levine Cancer Institute

location_facility: Ventura County Hematology and Oncology PMK Medical Group

location_facility: Shapiro and Stafford and Yee and Polanski Study Coordinator

location_facility: University of California at Los Angeles Dept. of UCLA

location_facility: Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

location_facility: University of California San Diego - Moores Cancer Center UCSD 3

location_facility: St Joseph Heritage Healthcare Dept. of RRMG (4)

location_facility: Charleston Hematology Oncology Association PA

location_facility: Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology

location_facility: Cancer Specialists of North Florida SC - F2302

location_facility: Central Coast Medical Oncology Corporation

location_facility: Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint

location_facility: St. Luke's Hospital and Health Network St Luke's (2)

location_facility: Santa Barbara Hematolgy Oncology Medical Group

location_facility: Cancer Care Associates Dept.ofCancerCareAssoc.

location_facility: Frederick Memorial Hospital Fred. Mem. Hosp.

location_facility: Washington University School of Medicine Regulatory

location_facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center

location_facility: Vanderbilt University Medical Center Vanderbilt - Thompson Ln

location_facility: USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)

location_facility: Oncology Hematology Associates of Southeast Virginia Salem VA Branch

location_facility: Los Angeles Hematology/Oncology Medical Group LA Cancer Network

location_facility: Dean Health System Dean Hematology Oncology

location_facility: University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)

location_facility: Cancer Care and Hematology Specialists of Chicagoland Niles

location_facility: Texas Oncology P A TX Onc - Med City Dallas

location_facility: West Michigan Cancer Center Dept of Oncology

location_facility: Oncology Consultants Oncology Consultants, P.A.

location_facility: Northwest Cancer Specialists Portland Loc

title: A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

summary: This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.


title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100

summary: This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

name: Glenn Heller, Martin Fleisher, and Howard I. Scher, Memorial Sloan Kettering Cancer Center; Howard I. Scher, Weill Cornell Medical College, New York, NY; Robert McCormack, Janssen Research & Development, Raritan, NJ; Thian Kheoh and Arturo Molina, Janssen Research & Development, Los Angeles; Dana T. Aftab, Exelixis, South San Francisco; Mohammad Hirmand, Medivation, San Francisco, CA; Matthew R. Smith, Massachusetts General Hospital, Boston; Ana Limon, Takeda Oncology, Cambridge, MA; Robert Dreicer,...

family: Heller

full_name: Glenn Heller

given: Glenn

family: McCormack

full_name: Robert McCormack

given: Robert

family: Kheoh

full_name: Thian Kheoh

given: Thian

family: Molina

full_name: Arturo Molina

given: Arturo

family: Smith

full_name: Matthew R. Smith

given: Matthew R.

family: Dreicer

full_name: Robert Dreicer

family: Saad

full_name: Fred Saad

given: Fred

family: de Wit

full_name: Ronald de Wit

given: Ronald

family: Aftab

full_name: Dana T. Aftab

given: Dana T.

family: Hirmand

full_name: Mohammad Hirmand

given: Mohammad

family: Limon

full_name: Ana Limon

given: Ana

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Fleisher

full_name: Martin Fleisher

given: Martin

family: de Bono

full_name: Johann S. de Bono

given: Johann S.

family: Scher

full_name: Howard I. Scher

given: Howard I.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Smith M, De Bono J, Sternberg C, Le Moulec S, Oudard S, De Giorgi U, Krainer M, Bergman A, Hoelzer W, De Wit R, Bögemann M, Saad F, Cruciani G, Thiery-Vuillemin A, Feyerabend S, Miller K, Houédé N, Hussain S, Lam E, Polikoff J, Stenzl A, Mainwaring P, Ramies D, Hessel C, Weitzman A, Fizazi K. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1. J Clin Oncol. 2016 Sep 1;34(25):3005-13. doi: 10.1200/JCO.2015.65.5597. Epub 2016 Jul 11.

name: Matthew Smith, Massachusetts General Hospital, Boston, MA; Johann De Bono, Royal Marsden Hospital, Sutton; Syed Hussain, University of Liverpool, Liverpool, United Kingdom; Cora Sternberg, San Camillo and Forlanini Hospitals, Rome; Ugo De Giorgi, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori–Istituto di Ricovero e Cura a Carattere Scientifico, Meldola; Giorgio Cruciani, Istituto Tumori Romagna, Lugo di Romagna, Italy; Sylvestre Le Moulec, Hôpital d’Instruction des Armées Val-de-Grâce;...

full_name: Matthew Smith

given: Matthew

family: De Bono

full_name: Johann De Bono

given: Johann

family: Sternberg

full_name: Cora Sternberg

given: Cora

family: Le Moulec

full_name: Sylvestre Le Moulec

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Ireland
Australia
Belgium
Puerto Rico
Spain
Canada
United Kingdom


title: (Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

acronym: APEX

summary: The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

primary_purpose: Prevention

ReferenceCitation: Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.

family: Jamil

full_name: Adeel Jamil

given: Adeel

full_name: Umer Jamil

given: Umer

family: Singh

full_name: Kamaldeep Singh

given: Kamaldeep

family: Khan

full_name: Faris Khan

given: Faris

family: Chi

full_name: Gerald Chi

given: Gerald

journal_name: Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Yee MK, Gibson CM, Nafee T, Kerneis M, Daaboul Y, Korjian S, Chi G, AlKhalfan F, Hernandez AF, Hull RD, Cohen AT, Goldhaber SZ. Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial. TH Open. 2019 Apr 17;3(2):e103-e108. doi: 10.1055/s-0039-1685496. eCollection 2019 Apr.

name: Boston Clinical Research Institute, Newton, Massachusetts, United States

family: Yee

full_name: Megan Yee

given: Megan

family: Gibson

full_name: C. Gibson

given: C.

family: Nafee

full_name: Tarek Nafee

given: Tarek

name: PERFUSE Study Group, Division of Cardiovascular, Departments of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States

family: Kerneis

full_name: Mathieu Kerneis

given: Mathieu

family: Daaboul

full_name: Yazan Daaboul

given: Yazan

family: Korjian

full_name: Serge Korjian

given: Serge

family: AlKhalfan

full_name: Fahad AlKhalfan

given: Fahad

name: Duke University and Duke Clinical Research Institute, Durham, North Carolina, United States

family: Hernandez

full_name: Adrian Hernandez

given: Adrian

name: Division of Cardiology, R.A.H. Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada

family: Hull

full_name: Russell Hull

given: Russell

name: Department of Haematological Medicine, Guy's and St Thomas' Hospitals, London, United Kingdom

family: Cohen

full_name: Alexander Cohen

given: Alexander

name: Division of Cardiovascular, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States

family: Goldhaber

full_name: Samuel Goldhaber

given: Samuel

journal_name: TH Open

oa_colors: green other

license: cc-by

license_normalized: cc-by

title: Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial

ReferenceCitation: Guy H, Laskier V, Fisher M, Bucior I, Deitelzweig S, Cohen AT. Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom. Expert Rev Pharmacoecon Outcomes Res. 2020 Jun;20(3):259-267. doi: 10.1080/14737167.2019.1629905. Epub 2019 Jun 19.

name: HEOR and Access, FIECON Ltd, St Albans, UK

name: Medical Affairs, Portola Pharmaceuticals, Inc, South San Francisco, CA, USA

name: Ochsner Clinical School, Ochsner Clinic Foundation and The University of Queensland School of Medicine, New Orleans, LA, USA

name: Department of Haematological Medicine, Guy’s and St. Thomas’ Hospitals, London, UK

journal_name: Expert Review of Pharmacoeconomics & Outcomes Research

ReferenceCitation: Chi G, Gibson CM, Kalayci A, Cohen AT, Hernandez AF, Hull RD, Kahe F, Jafarizade M, Sharfaei S, Liu Y, Harrington RA, Goldhaber SZ. Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy. Intensive Care Med. 2019 Apr;45(4):477-487. doi: 10.1007/s00134-019-05565-6. Epub 2019 Feb 18.

ReferenceCitation: Kalayci A, Gibson CM, Chi G, Yee MK, Korjian S, Datta S, Nafee T, Gurin M, Haroian N, Qamar I, Hull RD, Hernandez AF, Cohen AT, Harrington RA, Goldhaber SZ. Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial. Thromb Haemost. 2018 Dec;118(12):2046-2052. doi: 10.1055/s-0038-1675606. Epub 2018 Nov 12.

name: Division of Cardiovascular, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States

name: Division of Cardiology, R.A.H Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada

name: Duke Clinical Research Institute, Durham, North Carolina, United States

name: Department of Haematological Medicine, Guy's and St Thomas' Hospitals, King's College, London, United Kingdom

name: Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California, United States

ReferenceCitation: Chi G, Gibson CM, Liu Y, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ. Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial. Am J Hematol. 2019 Jan;94(1):21-28. doi: 10.1002/ajh.25296. Epub 2018 Oct 17.

name: Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center; Harvard Medical School; Boston Massachusetts

name: Baim Institute for Clinical Research; Boston Massachusetts

name: Duke University and Duke Clinical Research Institute; Durham North Carolina

name: Division of Cardiology, Faculty of Medicine; University of Calgary; Alberta Canada

name: Department of Haematological Medicine; Guy's and St Thomas’ Hospitals, King's College; London United Kingdom

name: Division of Cardiovascular Medicine, Department of Medicine; Stanford University; Stanford California

name: Division of Cardiovascular Medicine; Brigham and Women's Hospital, Harvard Medical School; Boston Massachusetts

ReferenceCitation: Chi G, Goldhaber SZ, Hull RD, Hernandez AF, Kerneis M, Al Khalfan F, Cohen AT, Harrington RA, Gibson CM. Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial. Thromb Haemost. 2017 Dec;117(12):2389-2395. doi: 10.1160/TH17-08-0538. Epub 2017 Dec 6.

ReferenceCitation: Yee MK, Nafee T, Daaboul Y, Korjian S, AlKhalfan F, Kerneis M, Wiest C, Goldhaber SZ, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Gibson CM. Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial. J Thromb Thrombolysis. 2018 Jan;45(1):1-8. doi: 10.1007/s11239-017-1583-0.

ReferenceCitation: Chi G, Januzzi JL, Korjian S, Daaboul Y, Goldhaber SZ, Hernandez AF, Hull RD, Gold A, Cohen AT, Harrington RA, Gibson CM. N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy. J Thromb Thrombolysis. 2017 Nov;44(4):457-465. doi: 10.1007/s11239-017-1552-7.

ReferenceCitation: Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, Goldhaber SZ, Harrington RA, Gold A, Cohen AT, Gibson CM. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445-450. doi: 10.1002/pst.1823. Epub 2017 Aug 24.

name: Cardiovascular Division, Department of Medicine; Beth Israel Deaconess Medical Center, Harvard Medical Center; Boston MA USA

name: Duke University and Duke Clinical Research Institute; Durham NC USA

name: R.A.H. Faculty of Medicine; Division of Cardiology, University of Calgary; Calgary AB Canada

name: Cardiovascular Division; Brigham and Women's Hospital, Harvard Medical School; Boston MA USA

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

name: Portola Pharmaceuticals Inc.; South San Francisco CA USA

name: Guy's and St. Thomas Hospitals; London UK

title: Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

name: Cardiovascular Division; Departments of Medicine; Beth Israel Deaconess Medical Center; Harvard Medical School; Boston MA USA

name: Cardiovascular Division; Brigham and Women's Hospital; Harvard Medical School; Boston MA USA

name: Department of Biostatistics and Informatics; Colorado School of Public Health; University of Colorado Anschutz Medical Campus; Aurora CO USA

name: Department of Medicine; Hamilton Health Sciences; General Division; Hamilton Ontario Canada

name: Division of Cardiology; R. A. H. Faculty of Medicine; University of Calgary; Calgary Alberta Canada

name: Department of Haematological Medicine; Guy's and St Thomas' Hospitals; King's College; London UK

name: Division of Cardiovascular Medicine; Department of Medicine; Stanford University; Stanford CA USA

ReferenceCitation: Gibson CM, Korjian S, Chi G, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Lopes RD, Gold A, Cohen AT, Harrington RA; APEX Investigators. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy. J Am Heart Assoc. 2017 Jul 11;6(7). pii: e006015. doi: 10.1161/JAHA.117.006015.

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

name: Division of Cardiology, R.A.H Faculty of Medicine, University of Calgary, Alberta, Canada

name: Duke University and Duke Clinical Research Institute, Durham, NC

name: Portola Pharmaceuticals Inc., South San Francisco, CA

name: Guy's and St Thomas’ Hospitals, London, United Kingdom

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

journal_name: Journal of the American Heart Association

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

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

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

repositories_institution: Università Cattolica del Sacro Cuore - PubliCatt

title: Comparison of Fatal or Irreversible Events With Extended‐Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy

ReferenceCitation: Gibson CM, Goldhaber SZ, Cohen AT, Nafee T, Hernandez AF, Hull R, Korjian S, Daaboul Y, Chi G, Yee M, Harrington RA. When academic research organizations and clinical research organizations disagree: Processes to minimize discrepancies prior to unblinding of randomized trials. Am Heart J. 2017 Jul;189:1-8. doi: 10.1016/j.ahj.2017.03.018. Epub 2017 Mar 31.

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

name: Department of Neurology, University of Arkansas for Medical Sciences, Little Rock, AR, USA

name: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA

name: Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

ReferenceCitation: Gibson CM, Chi G, Halaby R, Korjian S, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Gold A, Bandman O, Harrington RA, Cohen AT; APEX Investigators. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Circulation. 2017 Feb 14;135(7):648-655. doi: 10.1161/CIRCULATIONAHA.116.025427. Epub 2016 Nov 14.

name: From Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.M.G., G.C., R. Halaby, S.K., Y.D., P.J., D.A.); Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.Z.G.); Faculty of Medicine, Division of Cardiology, University of Calgary, AB, Canada (R. Hull); Duke University and Duke Clinical Research Institute Durham, NC (A.F.H.); Portola Pharmaceuticals Inc, South San Francisco, CA (A.G., O...

ReferenceCitation: Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.

repository_institution: St George's University of London - St George's Online Research Archive

repositories_institution: St George's University of London - St George's Online Research Archive

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

title: Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

ReferenceCitation: Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335-41. doi: 10.1016/j.ahj.2013.11.006. Epub 2013 Dec 10.

location_country:
Montserrat
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
South Africa
Chile
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
Georgia
Spain
Estonia
Latvia


ReferenceCitation: Schrieks IC, Nozza A, Stähli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Rydén L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.

family: Schrieks

full_name: Ilse C. Schrieks

given: Ilse C.

family: Nozza

full_name: Anna Nozza

given: Anna

family: Stähli

full_name: Barbara E. Stähli

given: Barbara E.

family: Buse

full_name: John B. Buse

given: John B.

family: Henry

full_name: Robert R. Henry

given: Robert R.

family: Malmberg

full_name: Klas Malmberg

given: Klas

family: Neal

full_name: Bruce Neal

given: Bruce

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

family: Rydén

full_name: Lars Rydén

given: Lars

family: Mellbin

full_name: Linda Mellbin

given: Linda

family: Svensson

full_name: Anders Svensson

given: Anders

family: Wedel

full_name: Hans Wedel

given: Hans

family: Weichert

full_name: Arlette Weichert

given: Arlette

family: Lincoff

full_name: A. Michael Lincoff

given: A. Michael

family: Tardif

full_name: Jean-Claude Tardif

given: Jean-Claude

family: Grobbee

full_name: Diederick E. Grobbee

given: Diederick E.

family: Schwartz

full_name: Gregory G. Schwartz

given: Gregory G.

journal_name: Diabetes Care

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repository_institution: Imperial College London - Spiral

version: submittedVersion

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.

name: Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio

name: Montreal Heart Institute Coordinating Center, Université de Montréal, Montreal, Canada

name: Veterans Affairs Medical Center and University of Colorado School of Medicine, Denver

name: South Australian Health and Medical Research Institute, University of Adelaide, Adelaide

name: George Institute for Global Health, University of Sydney, Sydney, Australia

name: Department of Medicine, Karolinska Institutet, Stockholm, Sweden7F. Hoffman-La Roche Ltd, Basel, Switzerland

name: Nordic School of Public Health, Frolunda, Sweden

name: University of North Carolina School of Medicine, Chapel Hill

name: University of California San Diego, San Diego

name: Julius Center for Health Sciences and Primary Care and Julius Clinical, University Medical Center Utrecht, Utrecht, the Netherlands

title: Effect of Aleglitazar on Cardiovascular Outcomes After Acute Coronary Syndrome in Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Rydén L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.

title: Evaluation of the dual peroxisome proliferator–activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: Rationale and design of the AleCardio trial

location_country:
Malaysia
Romania
Australia
Russian Federation
Denmark
Czech Republic
India
Grenada
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Ireland
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
New Zealand
Spain

title: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

summary: This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.


type: Other Grant/Funding Number

title: Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial

acronym: PEXIVAS

summary:
The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen.

The FDA-OOPD is one of the funding sources for this study.

ReferenceType: background

ReferenceCitation: Walsh M, Merkel PA, Peh CA, Szpirt W, Guillevin L, Pusey CD, De Zoysa J, Ives N, Clark WF, Quillen K, Winters JL, Wheatley K, Jayne D; PEXIVAS Investigators. Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial. Trials. 2013 Mar 14;14:73. doi: 10.1186/1745-6215-14-73.

ReferenceType: result

ReferenceCitation: Walsh M, Merkel PA, Peh CA, Szpirt WM, Puéchal X, Fujimoto S, Hawley CM, Khalidi N, Floßmann O, Wald R, Girard LP, Levin A, Gregorini G, Harper L, Clark WF, Pagnoux C, Specks U, Smyth L, Tesar V, Ito-Ihara T, de Zoysa JR, Szczeklik W, Flores-Suárez LF, Carette S, Guillevin L, Pusey CD, Casian AL, Brezina B, Mazzetti A, McAlear CA, Broadhurst E, Reidlinger D, Mehta S, Ives N, Jayne DRW; PEXIVAS Investigators. Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis. N Engl J Med. 2020 Feb 13;382(7):622-631. doi: 10.1056/NEJMoa1803537.

name: From the Population Health Research Institute, McMaster University–Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph’s Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael’s Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai...

family: Walsh

full_name: Michael Walsh

given: Michael

family: Merkel

full_name: Peter A. Merkel

given: Peter A.

family: Peh

full_name: Chen-Au Peh

given: Chen-Au

family: Szpirt

full_name: Wladimir M. Szpirt

given: Wladimir M.

family: Puéchal

full_name: Xavier Puéchal

given: Xavier

family: Fujimoto

full_name: Shouichi Fujimoto

given: Shouichi

family: Hawley

full_name: Carmel M. Hawley

given: Carmel M.

family: Khalidi

full_name: Nader Khalidi

given: Nader

family: Floßmann

full_name: Oliver Floßmann

given: Oliver

family: Wald

full_name: Ron Wald

given: Ron

family: Girard

full_name: Louis P. Girard

given: Louis P.

family: Levin

full_name: Adeera Levin

given: Adeera

family: Gregorini

full_name: Gina Gregorini

given: Gina

family: Harper

full_name: Lorraine Harper

given: Lorraine

family: Clark

full_name: William F. Clark

given: William F.

family: Pagnoux

full_name: Christian Pagnoux

given: Christian

family: Specks

full_name: Ulrich Specks

given: Ulrich

family: Smyth

full_name: Lucy Smyth

given: Lucy

family: Tesar

full_name: Vladimir Tesar

given: Vladimir

family: Ito-Ihara

full_name: Toshiko Ito-Ihara

given: Toshiko

family: de Zoysa

full_name: Janak Rashme de Zoysa

given: Janak Rashme

family: Szczeklik

full_name: Wojciech Szczeklik

given: Wojciech

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories:
PubMed Central
Pure (Denmark)
ora.ox.ac.uk

location_country:
Italy
United States
Sweden
Mexico
France
Czechia
Greece
Japan
Norway
Belgium
Australia
New Zealand
Denmark
Canada
United Kingdom

location_facility: CHU De Toulouse-Hotel Dieu Saint Jacques

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Instituto Nacional de Enfermedades Respiratorias

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: St Olavs Hospital, Trondheim University Hospital

location_facility: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Holstebro Hospital and University of Aarhus

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Washington University School of Medicine

location_facility: Brighton and Sussex University Hospitals


type: Other Identifier

title: A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

acronym: SQUIRE

summary: The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

ReferenceCitation: Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafrański W, Ramlau R, Bálint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.

family: Ciuleanu

full_name: Tudor Ciuleanu

given: Tudor

family: Socinski

full_name: Mark A. Socinski

given: Mark A.

family: Obasaju

full_name: Coleman Obasaju

given: Coleman

family: Luft

full_name: Alexander V. Luft

given: Alexander V.

family: Szczesna

full_name: Aleksandra Szczesna

given: Aleksandra

family: Szafrański

full_name: Wojciech Szafrański

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Bálint

full_name: Beatrix Bálint

given: Beatrix

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Depenbrock

full_name: Henrik Depenbrock

given: Henrik

family: Nanda

full_name: Shivani Nanda

given: Shivani

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Thatcher

full_name: Nick Thatcher

given: Nick

journal_name: Clinical Lung Cancer

title: Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non–Small-Cell Lung Cancer

ReferenceCitation: Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20.

full_name: L. Paz-Ares

given: L.

full_name: M.A. Socinski

family: Shahidi

full_name: J. Shahidi

given: J.

family: Hozak

full_name: R.R. Hozak

family: Soldatenkova

full_name: V. Soldatenkova

given: V.

family: Kurek

full_name: R. Kurek

given: R.

family: Varella-Garcia

full_name: M. Varella-Garcia

given: M.

title: Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine–cisplatin plus necitumumab versus gemcitabine–cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer

ReferenceCitation: Reck M, Socinski MA, Luft A, Szczęsna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.

ReferenceCitation: Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Bálint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Croatia
France
Poland
Slovakia
Thailand
Canada
Korea, Republic of
South Africa
Philippines
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Spain

location_facility:
ImClone Investigational site
ImClone Investigational Site


title: A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

summary: The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

ReferenceCitation: Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.

family: Diamant

full_name: Michaela Diamant

given: Michaela

family: Nauck

full_name: Michael A. Nauck

given: Michael A.

family: Shaginian

full_name: Rimma Shaginian

given: Rimma

family: Malone

full_name: James K. Malone

given: James K.

family: Cleall

full_name: Simon Cleall

given: Simon

family: Reaney

full_name: Matthew Reaney

given: Matthew

family: de Vries

full_name: Danielle de Vries

given: Danielle

family: Hoogwerf

full_name: Byron J. Hoogwerf

given: Byron J.

family: MacConell

full_name: Leigh MacConell

given: Leigh

family: Wolffenbuttel

full_name: Bruce H.R. Wolffenbuttel

given: Bruce H.R.

oa_host_type: publisher

title: Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Type 2 Diabetes

lead_sponsor: AstraZeneca

location_country:
Italy
Sweden
Mexico
Netherlands
Spain
Finland
France
Greece
Romania
Belgium
Argentina
Puerto Rico
Portugal
Estonia
Russian Federation
Germany
United Kingdom
Korea, Republic of

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Verstovsek S, Gotlib J, Mesa RA, Vannucchi AM, Kiladjian JJ, Cervantes F, Harrison CN, Paquette R, Sun W, Naim A, Langmuir P, Dong T, Gopalakrishna P, Gupta V. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017 Sep 29;10(1):156. doi: 10.1186/s13045-017-0527-7.

family: Verstovsek

full_name: Srdan Verstovsek

given: Srdan

family: Gotlib

full_name: Jason Gotlib

given: Jason

family: Mesa

full_name: Ruben A. Mesa

given: Ruben A.

family: Vannucchi

full_name: Alessandro M. Vannucchi

given: Alessandro M.

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

family: Cervantes

full_name: Francisco Cervantes

given: Francisco

family: Harrison

full_name: Claire N. Harrison

given: Claire N.

family: Paquette

full_name: Ronald Paquette

given: Ronald

family: Sun

full_name: William Sun

given: William

family: Naim

full_name: Ahmad Naim

given: Ahmad

family: Langmuir

full_name: Peter Langmuir

given: Peter

family: Dong

full_name: Tuochuan Dong

given: Tuochuan

family: Gopalakrishna

full_name: Prashanth Gopalakrishna

given: Prashanth

family: Gupta

full_name: Vikas Gupta

given: Vikas

currency_apc_doaj: GBP

journal_name: Journal of Hematology & Oncology

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: McMullin MF, Harrison CN, Niederwieser D, Demuynck H, Jäkel N, Gopalakrishna P, McQuitty M, Stalbovskaya V, Recher C, Theunissen K, Gisslinger H, Kiladjian JJ, Al-Ali HK. The use of erythropoiesis-stimulating agents with ruxolitinib in patients with myelofibrosis in COMFORT-II: an open-label, phase 3 study assessing efficacy and safety of ruxolitinib versus best available therapy in the treatment of myelofibrosis. Exp Hematol Oncol. 2015 Sep 15;4:26. doi: 10.1186/s40164-015-0021-2. eCollection 2015.

family: McMullin

full_name: Mary Frances McMullin

given: Mary Frances

repositories_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Vannucchi AM, Kantarjian HM, Kiladjian JJ, Gotlib J, Cervantes F, Mesa RA, Sarlis NJ, Peng W, Sandor V, Gopalakrishna P, Hmissi A, Stalbovskaya V, Gupta V, Harrison C, Verstovsek S; COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015 Sep;100(9):1139-45. doi: 10.3324/haematol.2014.119545. Epub 2015 Jun 11.

repository_institution: University of Florence - Florence Research

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Cervantes F, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Sirulnik A, Stalbovskaya V, McQuitty M, Hunter DS, Levy RS, Passamonti F, Barbui T, Barosi G, Harrison CN, Knoops L, Gisslinger H; COMFORT-II investigators. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013 Dec 12;122(25):4047-53. doi: 10.1182/blood-2013-02-485888. Epub 2013 Oct 30. Erratum in: Blood. 2016 Dec 22;128(25):3013.

name: Hospital Clínic, Hematology Department, Institut d'Investigació Biomédica August Pi i Sunyer, University of Barcelona, Barcelona, Spain;

name: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy;

name: The Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Louis, Centre d'Investigations Cliniques and Department of Clinical Pharmacology, Université Paris Diderot, Paris, France;

name: Division of Hematology and Medical Oncology, University of Leipzig, Leipzig, Germany;

name: Novartis Clinical Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ;

name: Oncology Global Development, Novartis Pharma AG, Basel, Switzerland;

name: Clinical Development, Incyte Corporation, Wilmington, DE;

name: Department of Hematology, Ospedale di Circolo e Fondazione Macchi, Varese, Italy;

name: Department of Hematology, Azienda Ospedaliera Ospedali Riuniti di Bergamo, Bergamo, Italy;

name: Center for the Study of Myelofibrosis, Istituto Di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo Foundation, Pavia, Italy;

name: Department of Haematology, Guy’s and St. Thomas’ National Health Service Foundation Trust, London, United Kingdom;

name: Hematology Unit, Cliniques Universitaires Saint-Luc and de Duve Institute, Université Catholique de Louvain, Brussels, Belgium; and

name: Department of Internal Medicine, Medical University of Vienna, Vienna, Austria

ReferenceCitation: Wilkins BS, Radia D, Woodley C, Farhi SE, Keohane C, Harrison CN. Resolution of bone marrow fibrosis in a patient receiving JAK1/JAK2 inhibitor treatment with ruxolitinib. Haematologica. 2013 Dec;98(12):1872-6. doi: 10.3324/haematol.2013.095109. Epub 2013 Sep 20.

ReferenceCitation: Mesa RA, Kiladjian JJ, Verstovsek S, Al-Ali HK, Gotlib J, Gisslinger H, Levy R, Siulnik A, Gupta V, Khan M, DiPersio JF, McQuitty M, Catalano JV, Hunter DS, Knoops L, Deininger M, Cervantes F, Miller C, Vannucchi AM, Silver RT, Barbui T, Talpaz M, Barosi G, Winton EF, Mendeson E, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Sun W, Sandor V, Kantarjian HM, Harrison C. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014 Feb;99(2):292-8. doi: 10.3324/haematol.2013.087650. Epub 2013 Aug 2.

ReferenceCitation: Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi: 10.1056/NEJMoa1110556.

title: JAK Inhibition with Ruxolitinib versus Best Available Therapy for Myelofibrosis

location_country:
Italy
Austria
Sweden
Netherlands
France
Belgium
Spain
Germany
United Kingdom

title: A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

summary: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).


ReferenceCitation: Gual A, He Y, Torup L, van den Brink W, Mann K; ESENSE 2 Study Group. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 Nov;23(11):1432-42. doi: 10.1016/j.euroneuro.2013.02.006. Epub 2013 Apr 3.

family: Gual

full_name: Antoni Gual

given: Antoni

family: He

full_name: Yuan He

given: Yuan

family: Torup

full_name: Lars Torup

given: Lars

family: van den Brink

full_name: Wim van den Brink

given: Wim

family: Mann

full_name: Karl Mann

given: Karl

journal_name: European Neuropsychopharmacology

ReferenceCitation: Aubin HJ, Reimer J, Nutt DJ, Bladström A, Torup L, François C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.

family: Aubin

full_name: Henri-Jean Aubin

given: Henri-Jean

family: Reimer

full_name: Jens Reimer

given: Jens

family: Nutt

full_name: David J. Nutt

given: David J.

family: Bladström

full_name: Anna Bladström

given: Anna

family: François

full_name: Clément François

given: Clément

family: Chick

full_name: Jonathan Chick

given: Jonathan

journal_name: European Addiction Research

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: Clinical Relevance of As-Needed Treatment with Nalmefene in Alcohol-Dependent Patients

ReferenceCitation: Laramée P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, François C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

family: Laramee

full_name: P. Laramee

given: P.

family: Brodtkorb

full_name: T.-H. Brodtkorb

family: Rahhali

full_name: N. Rahhali

given: N.

family: Knight

full_name: C. Knight

given: C.

family: Barbosa

full_name: C. Barbosa

family: Francois

full_name: C. Francois

family: Toumi

full_name: M. Toumi

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

ReferenceCitation: van den Brink W, Aubin HJ, Bladström A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19. Erratum in: Alcohol Alcohol. 2013 Nov-Dec;48(6):746.

title: Efficacy of As-Needed Nalmefene in Alcohol-Dependent Patients with at Least a High Drinking Risk Level: Results from a Subgroup Analysis of Two Randomized Controlled 6-Month Studies

location_country:
Italy
Spain
France
Poland
Belgium
Portugal
Czech Republic

title: Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.