title: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

summary: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

family: Gibson

full_name: Peter G. Gibson

given: Peter G.

family: Prazma

full_name: Charlene M. Prazma

given: Charlene M.

family: Chupp

full_name: Geoffrey L. Chupp

given: Geoffrey L.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Forshag

full_name: Mark Forshag

given: Mark

family: Mallett

full_name: Stephen A. Mallett

given: Stephen A.

family: Yancey

full_name: Steve W. Yancey

given: Steve W.

full_name: Steven G. Smith

given: Steven G.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

currency_apc_doaj: GBP

journal_name: Respiratory Research

ReferenceCitation: Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

full_name: Steven W. Yancey

given: Steven W.

family: Ortega

full_name: Hector G. Ortega

given: Hector G.

family: Keene

full_name: Oliver N. Keene

given: Oliver N.

journal_name: Allergy, Asthma & Clinical Immunology

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

ReferenceCitation: Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther. 2016 Sep;38(9):2058-2070.e1. doi: 10.1016/j.clinthera.2016.07.010. Epub 2016 Aug 21.

location_country:
Italy
United States
Chile
Mexico
Netherlands
Germany
Spain
France
Czechia
Japan
Poland
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
Ukraine


ReferenceType: derived

ReferenceCitation: Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24. Erratum in: Lancet. 2017 Mar 4;389(10072):908.

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

sequence: first

family: Tan

full_name: Daniel S W Tan

given: Daniel S W

sequence: additional

family: Chiari

full_name: Rita Chiari

given: Rita

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Wolf

full_name: Juergen Wolf

given: Juergen

family: Geater

full_name: Sarayut L Geater

given: Sarayut L

family: Orlov

full_name: Sergey Orlov

given: Sergey

family: Cortinovis

full_name: Diego Cortinovis

given: Diego

family: Yu

full_name: Chong-Jen Yu

given: Chong-Jen

family: Hochmair

full_name: Maximillian Hochmair

given: Maximillian

family: Cortot

full_name: Alexis B Cortot

given: Alexis B

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Campelo

full_name: Rosario G Campelo

given: Rosario G

family: McCulloch

full_name: Tracey McCulloch

given: Tracey

family: Sen

full_name: Paramita Sen

given: Paramita

family: Dugan

full_name: Margaret Dugan

given: Margaret

family: Pantano

full_name: Serafino Pantano

given: Serafino

family: Branle

full_name: Fabrice Branle

given: Fabrice

family: Massacesi

full_name: Cristian Massacesi

given: Cristian

family: de Castro

full_name: Gilberto de Castro

given: Gilberto

suffix: Jr

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: First-line ceritinib versus platinum-based chemotherapy in advanced ALK -rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. Review.

title: Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non–Small-Cell Lung Cancer: Analysis and Literature Review

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:
Greece
Australia
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Thailand
Norway
Korea, Republic of
Colombia
Sweden
Netherlands
Singapore
Ireland
Portugal
China
Germany
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Spain
Turkey

title: A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

summary: The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378 after confirmed progressive disease (PD).


ReferenceCitation: Jacobsen AA, Kydd AR, Strasswimmer J. Practical management of the adverse effects of Hedgehog pathway inhibitor therapy for basal cell carcinoma. J Am Acad Dermatol. 2017 Apr;76(4):767-768. doi: 10.1016/j.jaad.2016.04.063.

family: Jacobsen

full_name: Audrey A. Jacobsen

given: Audrey A.

family: Kydd

full_name: Andre R. Kydd

given: Andre R.

family: Strasswimmer

full_name: John Strasswimmer

given: John

journal_name: Journal of the American Academy of Dermatology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

ReferenceCitation: Dréno B, Kunstfeld R, Hauschild A, Fosko S, Zloty D, Labeille B, Grob JJ, Puig S, Gilberg F, Bergström D, Page DR, Rogers G, Schadendorf D. Two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas (MIKIE): a randomised, regimen-controlled, double-blind, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):404-412. doi: 10.1016/S1470-2045(17)30072-4. Epub 2017 Feb 8.

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

family: Kunstfeld

full_name: Rainer Kunstfeld

given: Rainer

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Fosko

full_name: Scott Fosko

given: Scott

family: Zloty

full_name: David Zloty

given: David

family: Labeille

full_name: Bruno Labeille

given: Bruno

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Puig

full_name: Susana Puig

given: Susana

family: Gilberg

full_name: Frank Gilberg

given: Frank

family: Bergström

full_name: Daniel Bergström

given: Daniel

family: Page

full_name: Damian R Page

given: Damian R

family: Rogers

full_name: Gary Rogers

given: Gary

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

journal_name: The Lancet Oncology

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Hoffmann-La Roche

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
Austria
Mexico
Netherlands
Germany
France
Russian Federation
Spain
United States
Canada

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Università di Brescia; Dipartimento di Dermatologia

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Dermatology and Laser Center of Charleston PA

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Washington University School of Medicine

location_facility: VU MEDISCH CENTRUM;Afdeling Dermatologie

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Maastricht University Medical Centre; Dermatologie

location_facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

location_facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

location_facility: Hospital General Dr. Manuel Gea Gonzalez; Dermatology

location_facility: Hospital Costa Del Sol; Servicio de Dermatologia

location_facility: Skin and Cancer Associates and the Center for Cosmetic Enhancement

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Long Island Skin Cancer and Dermatologic Surgery

location_facility: Arcispedale Santa Maria Nuova; Dermatologia

location_facility: Beverly Hospital;Oncology Center Pharmacy

location_facility: FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed

location_facility: Blokhin Cancer Research Center; General Oncology Department

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Saint Louis University School of Medicine; Department of Dermatology

location_facility: LKH Innsbruck; Universitätsklinik für Dermatologie

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: UBC Department of Dermatology & Skin Sciences

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: California Pacific Medical Center Research Institute

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

summary: This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

lead_sponsor_type: industriel


title: A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

acronym: Galaxy 2

summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

status: Terminated

lead_sponsor: Synta Pharmaceuticals Corp.

location_country:
Italy
Austria
United States
Bosnia and Herzegovina
Serbia
United Kingdom
Netherlands
Germany
Croatia
France
Poland
Slovenia
Romania
Hungary
Belgium
Russian Federation
Spain
Canada
Czech Republic
Ukraine

location_facility: Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

location_facility: University of Miami Health System Sylvester at Deerfield Beach

location_facility: Pneumologisches Forschungsinstitut an der Lungenclinic Gross

location_facility: St. Louis Cancer Care, LLP - North County

location_facility: Cancer Care Specialists of Central Illinois, S.C.

location_facility: Országos Korányi TBC és Pulmonológiai Intézet

location_facility: Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera

location_facility: Emory University - Winship Cancer Institute

location_facility: Sint Antoniusziekenhuis, location Utrecht

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Algemeen Stedelijk Ziekenhuis - Campus Aalst

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: Medizinische Fakultät Mannheim Uni Heidelberg

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: University Of North Carolina At Chapel Hill

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: Institute for pulmonary diseases of Vojvodine

location_facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Univerzitetna klinika za pljucne bolesti in alergijo Golnik

location_facility: Clinical Center University of Sarajevo, Clinic of Oncology

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital d

location_facility: Sozialmedizinisches Zentrum Baumgartner Höhe

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena

location_facility: Eastern Connecticut Hematology Associates

location_facility: Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

location_facility: INDC Entité Jolimontoise - Polyclinique de Jolimont

location_facility: Synta Pharmaceuticals Investigational Site

location_facility: Novant Health Presbyterian Medical Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: New Hanover Regional Medical Center - Zimmer Cancer Center

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca

location_facility: Houston Methodist Hospital Research Institute

location_facility: North Shore Hematology Oncology Associates

location_facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: UC Davis Medical Center - UC Davis Comprehensive Cancer

location_facility: Synta Pharmaceuticals Investigative Site

location_facility: University of South Florida - H. Lee Moffitt

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Erlanger Institute for Clinical Research

location_facility: Gemeinschaftspraxis fuer Haematologie und Onkologie

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Fort Wayne Medical Oncology and Hematology Inc

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Johann Wolfgang Goethe University Clinic Frankfurt

location_facility: Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach

location_facility: City of Hope Comprehensive Breast Cancer Center

location_facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia, Universi

location_facility: Hospital de Mataró, Consorci Sanitari del Maresme

location_facility: Green Bay Oncology, Ltd. - St. Mary's Site

location_facility: The Center for Cancer and Blood Disorders (CCBD) - Bethesda

location_facility: St. Joseph Hospital, Center for Cancer Prevention and Treatment

location_facility: Centre Hosptalier De Villefranche-Sur-Saone

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Providence Regional Medical Center Everett

status_simplified: Unknown


title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).

acronym: COMPASS

summary:
The primary objectives of this study are:

To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.

family: Anand

full_name: Sonia S. Anand

given: Sonia S.

family: Caron

full_name: Francois Caron

given: Francois

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

family: Bosch

full_name: Jackie Bosch

given: Jackie

family: Dyal

full_name: Leanne Dyal

given: Leanne

family: Aboyans

full_name: Victor Aboyans

given: Victor

family: Abola

full_name: Maria Teresa Abola

given: Maria Teresa

family: Branch

full_name: Kelley R.H. Branch

given: Kelley R.H.

family: Keltai

full_name: Katalin Keltai

given: Katalin

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Verhamme

full_name: Peter Verhamme

given: Peter

family: Fox

full_name: Keith A.A. Fox

given: Keith A.A.

family: Cook-Bruns

full_name: Nancy Cook-Bruns

given: Nancy

family: Lanius

full_name: Vivian Lanius

given: Vivian

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Yusuf

full_name: Salim Yusuf

given: Salim

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease

ReferenceCitation: Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.

full_name: Sonia S Anand

given: Sonia S

full_name: John W Eikelboom

given: John W

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

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

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10. Erratum in: Lancet. 2017 Dec 21;:.

ReferenceCitation: Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Störk S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.

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

repository_institution: University College London - UCL Discovery

repositories_institution: University College London - UCL Discovery

title: Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

ReferenceCitation: Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Félix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083.

ReferenceCitation: Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Jun 16. doi: 10.1001/jamacardio.2021.1686. [Epub ahead of print] Erratum in: JAMA Cardiol. 2021 Aug 18;:null.

name: Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada

name: Department of Surgery, McMaster University, Hamilton, Ontario, Canada

name: Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

name: Department of Medicine, McMaster University, Hamilton, Ontario, Canada

name: Department of Cardiovascular Surgery, Fuwai Hospital, Beijing, China

name: Department of Cardiac Surgery, Quebec Heart and Lung Institute affiliated with Laval University, Quebec City, Quebec, Canada

name: Department of Cardiac Surgery, Centre Hospitalier de l’Universite de Montreal, Montreal, Quebec, Canada

name: Department of Thoracic and Cardiovascular Surgery, Nanjing First Hospital affiliated with Nanjing Medical University, Nanjing, China

name: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio

name: Department of Cardiac Surgery, Fakultní Nemocnice Hradec Králové, Hradec Králové, Královéhradecký, Czech Republic

ReferenceCitation: Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21.

ReferenceCitation: Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA(2)DS(2)-VASc and CHADS(2) scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3.

title: Risk stratification of cardiovascular complications using CHA2DS2-VASc and CHADS2 scores in chronic atherosclerotic cardiovascular disease

ReferenceCitation: Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061.

ReferenceCitation: Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Störk S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21. Erratum in: Stroke. 2021 Jan;52(2):e90.

name: Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).

name: Hotchkiss Brain Institute, University of Calgary, AB, Canada (E.E.S.).

name: School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada (J.B.).

name: Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario, Argentina (R.D.).

name: Research Institute, FOSCAL-Bucaramanga, Colombia (P.L.-J.).

name: Comprehensive Heart Failure Center, University and University Hospital, Würzburg, Germany (G.E., S.S.).

name: Institut Universitaire de Cardiologie et Pneumologie de Quebec, Quebec City, Canada (G.R.D.).

name: Karolinska Institutet, Stockholm, Sweden (L.R.).

name: Monash University, Melbourne, Australia (A.M.T., J.D.V.).

name: Brigham and Women’s Hospital Heart and Vascular Center, Harvard, Medical School, Boston, MA (D.L.B.).

name: University of Washington Medical Centre, Seattle (K.R.H.B.).

name: University of Washington, Seattle (K.R.H.B., J.L.P.).

name: The Catholic University of Korea, Seoul, Korea (J.-H.K.).

name: National University of Ireland Galway, Galway, Ireland (M.O.).

name: University of Medicine and Pharmacology Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.).

name: Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom (K.A.A.F.).

name: FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).

name: National Medical Research Center of Cardiology, Moscow, Russia (N.P.).

name: ANMCO Research Center, Florence, Italy (A.P.M.).

name: Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil (A.A.).

name: University of Sao Paulo, Sao Paulo, Brazil (L.S.P.).

name: Semmelweis University, Budapest, Hungary (K.K., M.K.).

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline

ReferenceCitation: Catanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10.

title: Oral factor Xa inhibitors and risk of subdural hematoma

ReferenceCitation: Steffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21. Erratum in: Circulation. 2020 Jul 7;142(1):e23.

name: Department of Cardiology, University Heart Center Zurich, Switzerland (J.S.).

name: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada (J.W.E., S.S.A., O.S., S.Y.).

name: Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).

title: The COMPASS Trial

ReferenceCitation: Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimský P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28.

name: Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School Boston, MA (D.L.B.).

name: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., S.S.A., J.B., O.S., S.Y.).

name: Université de Paris and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).

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

name: University of Washington Medical Centre, Seattle (K.R.H.B., J.P.).

name: School of Rehabilitation Science, Mc-Master University, Hamilton, Ontario, Canada (J.B.).

name: State University of New York, Downstate School of Public Health, Brooklyn (M.S.).

name: Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (P.W.).

name: Hospital Alemão Oswaldo Cruz, São Paulo, Brazil (A.A.).

name: Estudios Clínicos Latino América, Rosario, Argentina (R.D.).

name: Instituto Cardiovascular de Rosario, Argentina (R.D.).

name: Lady Davis Carmel Medical Centre and the Technion-Israel Institute of Technology, Haifa (B.S.L.).

name: Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden (L.R.).

ReferenceCitation: Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17. Erratum in: Circulation. 2020 Jun 9;141(23):e905.

name: Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (K.R.B., R.C.W.).

name: Population Heath Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (S.J.C., T.M., J.B., S.Y., J.W.E.).

name: Department of Medicine, University of Edinburgh, UK (K.A.A.F.).

name: Assistance Publique–Hôpitaux de Paris, France (P.G.S.).

name: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania (D.V.).

name: Bayer AG, Parsippany, NJ (S.D.B., J.M.F.).

name: University of Washington, Seattle (J.L.P., K.R.B.).

name: Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.).

name: Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Argentina (R.D.).

name: Charles University, Prague, Czech Republic (P.W.).

name: Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).

ReferenceCitation: Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065.

ReferenceCitation: Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984.

name: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada

title: Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes

ReferenceCitation: Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Rydén L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12.

name: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada (J.W.E., S.J.C., J.B., O.S., S.S.A., R.G.H., P.M., S.Y.).

name: School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada (J.B.).

name: Department of Cardiology, Dupuytren University Hospital, Limoges, France (V.A.).

name: Amphia Ziekenhuis and WCN, Utrecht, the Netherlands (M.A.).

name: Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).

name: Bayer AG, Leverkusen, Germany (N.C.-B.).

name: Facultad de Ciencias de la Salud Eugenio Espejo–Universidad UTE, Quito, Ecuador (C.F.).

name: Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.).

name: FuWai Hospital, CAMS & PUMC, Beijing, China (J.Z.).

title: Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis

ReferenceCitation: Branch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5.

name: Cardiology Division, University of Washington, Seattle (K.R.B., J.L.P., R.K.C.).

name: Population Health Research Institute, McMaster University and Hamilton Health Sciences, ON, Canada (J.W.E., J.B., S.J.C., O.S., S.Y.).

name: National Association of Hospital Cardiologists Research Center (ANMCO), Firenze, Italy (A.P.M.).

name: Dante Pazzanese Institute of Cardiology and Hospital Alemão Oswaldo Cruz, São Paulo, Brazil (A.A.).

name: Centre for Cardiovascular Science, University of Edinburgh, Scotland (K.A.A.F.).

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Störk S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.

ReferenceCitation: Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Störk S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2.

ReferenceCitation: Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864.

name: McMaster University/Population Health Research Institute, Hamilton, Canada (M.S., R.G.H., S.J.C., J.B., O.S., K.K.H.N., L.C., S.Y., J.W.E.).

name: Semmelweis University, Budapest, Hungary (K.K.).

name: Dupuytren University Hospital, Limoges, France (V.A.).

name: Amphia Ziekenhuis and Werkgroep Cardiologische centra Nederland, Utrecht, Nederlands (M.A.).

name: Yonsei University College of Medicine, Seoul, Korea (J.-W.H.).

name: Monash University, Clayton, Melbourne, Australia (J.V., A.T.).

name: National University of Ireland, Galway, Ireland (M.O.).

name: Brigham and Women’s Hospital, Boston, MA (D.L.B.).

name: University of Edinburgh, Scotland (K.F.).

name: Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.M.).

name: Bayer AG, Wuppertal, Germany (S.D.B., N.C.B.).

title: Stroke Outcomes in the COMPASS Trial

ReferenceCitation: Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.

title: Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion

ReferenceCitation: Bhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12.

name: Department of Medicine, McMaster University, Hamilton, ON, L8S 4K1, Canada.

name: Population Health Research Institute, Hamilton, ON, L8L 2X2, Canada

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Finland
Malaysia
Romania
Belgium
Australia
Russian Federation
Denmark
Ukraine
Ecuador
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Philippines
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel


title: A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

summary: The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

ReferenceType: background

ReferenceCitation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.

ReferenceCitation: Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceCitation: Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.

ReferenceCitation: Robinson JG, Nedergaard BS, Rogers WJ, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014 May 14;311(18):1870-82. doi: 10.1001/jama.2014.4030.

ReferenceCitation: Robinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30.

ReferenceCitation: Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.

ReferenceCitation: Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.

ReferenceCitation: Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, López JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

ReferenceCitation: Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.

lead_sponsor: Amgen

location_country:
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Spain

status_simplified: Completed


ReferenceCitation: Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.

name: Centro Paulista De Dor, São Paulo, Brazil;

family: Palladini

full_name: Mariana Palladini

given: Mariana

name: Innovation Unit Pain – Clinical Science, Grünenthal GmbH, Aachen, Germany;

family: Boesl

full_name: Irmgard Boesl

given: Irmgard

family: Koenig

full_name: Simone Koenig

given: Simone

name: Biostatistics, Grünenthal GmbH, Aachen, Germany;

family: Buchheister

full_name: Bettina Buchheister

given: Bettina

name: Université Versailles Saint Quentin en Yvelines, Versailles, France

family: Attal

full_name: Nadine Attal

given: Nadine

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Grünenthal GmbH

location_country:
Italy
Austria
Brazil
France
Belgium
Spain
Denmark
United Kingdom

title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain

summary: The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.


title: A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
France
Korea, Republic of
Spain
United States
Canada

location_facility: University of California, San Diego Medical Center

location_facility: Yale University School of Medicine-Yale Cancer Center

location_facility: University of Cincinnati Cancer Institute

location_facility: University of Nebraska Medical Center Eppley Cancer Center

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: Centre Hospitalier Regional Universitaire Besancon

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Washington University School of Medicine

location_facility: Hospital Regional Universitario de Malaga

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Indiana University Melvin and and Bren Simon Cancer Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Pennsylvania State University-Penn State

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Sharp Clinical Oncology Research-Sharp Memorial Hospital

location_facility: University of Texas Southwestern Medical Center


type: Other Identifier

title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

acronym: RA-BEAM

summary: The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

ReferenceCitation: Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2021 Oct 27. pii: annrheumdis-2021-221276. doi: 10.1136/annrheumdis-2021-221276. [Epub ahead of print]

family: Taylor

full_name: Peter C Taylor

given: Peter C

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Durez

full_name: Patrick Durez

given: Patrick

family: Smolen

full_name: Josef S Smolen

given: Josef S

family: Deberdt

full_name: Walter Deberdt

given: Walter

family: Issa

full_name: Maher Issa

given: Maher

family: Terres

full_name: Jorge Ross Terres

given: Jorge Ross

family: Bello

full_name: Natalia Bello

given: Natalia

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

host_type: repository

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2021 Sep 15. pii: jrheum.210346. doi: 10.3899/jrheum.210346. [Epub ahead of print]

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Kartman

full_name: Cynthia E. Kartman

given: Cynthia E.

family: Xie

full_name: Li Xie

given: Li

family: Beattie

full_name: Scott Beattie

given: Scott

family: Schlichting

full_name: Douglas Schlichting

given: Douglas

family: Mo

full_name: Daojun Mo

given: Daojun

family: Tanaka

full_name: Yoshiya Tanaka

title: Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND

ReferenceCitation: Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum in: Arthritis Res Ther. 2020 Jul 2;22(1):166.

ReferenceCitation: Schlueter M, Finn E, Díaz S, Dilla T, Inciarte-Mundo J, Fakhouri W. Cost-effectiveness analysis of baricitinib versus adalimumab for the treatment of moderate-to-severe rheumatoid arthritis in Spain. Clinicoecon Outcomes Res. 2019 Jun 6;11:395-403. doi: 10.2147/CEOR.S201621. eCollection 2019.

ReferenceCitation: Michaud K, Pope JE, Emery P, Zhu B, Gaich CL, DeLozier AM, Zhang X, Dickson CL, Smolen JS. Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial. Rheumatol Ther. 2019 Sep;6(3):409-419. doi: 10.1007/s40744-019-0164-4. Epub 2019 Jun 21.

ReferenceCitation: Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.

ReferenceCitation: Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0. Erratum in: Trials. 2019 Jun 4;20(1):322.

ReferenceCitation: Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum in: J Rheumatol. 2019 Dec;46(12):1648-1649.

ReferenceCitation: Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

name: University of Occupational and Environmental Health Japan Kitakyushu Japan

name: Botnar Research Centre and University of Oxford Oxford UK

name: Eli Lilly and Company Indianapolis Indiana

name: NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, and University of Leeds Leeds UK

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

repository_institution: The University of Glasgow - Enlighten: Publications

title: Characterization and Changes of Lymphocyte Subsets in Baricitinib‐Treated Patients With Rheumatoid Arthritis

ReferenceCitation: Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.

ReferenceCitation: Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20. Review.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, Zamora JV, Cobos JAC, Rooney T, Bono S, Arora V, Linetzky B, Weinblatt ME. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017 Nov;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259. Epub 2017 Aug 10.

ReferenceCitation: Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.

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

location_country:
Greece
Romania
Belgium
Russian Federation
Taiwan
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Switzerland
Hungary
Puerto Rico
China
Portugal
United States
Germany
United Kingdom
Mexico
Czechia
Spain
Latvia

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Rheumatology Associates of Central Florida

location_facility: Clinical Research Center of Reading, LLP

location_facility: Asheville Rheumatology & Osteoporosis Research Assoc, PA

location_facility: Carolina Rheumatology and Neurology Associates

location_facility: (AOA) Arthritis & Osteoporosis Associates


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

ReferenceCitation: Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Oct 2. doi: 10.1007/s13555-021-00618-5. [Epub ahead of print]

family: Kokolakis

full_name: Georgios Kokolakis

given: Georgios

family: Vadstrup

full_name: Kasper Vadstrup

given: Kasper

family: Hansen

full_name: Jes B. Hansen

given: Jes B.

family: Carrascosa

full_name: Jose Manuel Carrascosa

given: Jose Manuel

journal_name: Dermatology and Therapy

evidence: oa journal (via doaj)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

family: Gottlieb

full_name: Alice Gottlieb

given: Alice

family: Lebwohl

full_name: Mark Lebwohl

given: Mark

family: Liu

full_name: Clive Liu

given: Clive

family: Israel

full_name: Robert J. Israel

given: Robert J.

family: Jacobson

full_name: Abby Jacobson

given: Abby

journal_name: American Journal of Clinical Dermatology

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

ReferenceCitation: McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.

family: McMichael

full_name: Amy McMichael

given: Amy

family: Desai

full_name: Seemal R. Desai

given: Seemal R.

family: Qureshi

full_name: Aamir Qureshi

given: Aamir

family: Rastogi

ReferenceCitation: Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.

name: University of Southern California Los Angeles CA U.S.A

name: Icahn School of Medicine at Mount Sinai New York NY U.S.A

name: Oregon Medical Research Center Portland OR U.S.A

name: Temple University School of Medicine Philadelphia PA U.S.A

name: University of Texas Health Science Center Houston TX U.S.A

name: Ortho Dermatologics Bridgewater NJ U.S.A

name: Dow Pharmaceutical Sciences Petaluma CA U.S.A

name: Valeant Pharmaceuticals North America LLC Bridgewater NJ U.S.A

ReferenceCitation: Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

location_country:
Austria
United States
Netherlands
Spain
France
Czechia
Poland
Hungary
Australia
Portugal
Canada


title: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

summary:
The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.

In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.

After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).

Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient first treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. Once the study is analyzed for survival at 4 years after last patient started study treatment, any patient still on treatment may continue to be treated and followed under a separate provision to be determined (e.g. roll-over-study). The end of study notification to Health Authorities will be based on the completion of the collection of survival data.

The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceCitation: Dreyling M, Morschhauser F, Bouabdallah K, Bron D, Cunningham D, Assouline SE, Verhoef G, Linton K, Thieblemont C, Vitolo U, Hiemeyer F, Giurescu M, Garcia-Vargas J, Gorbatchevsky I, Liu L, Koechert K, Peña C, Neves M, Childs BH, Zinzani PL. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. doi: 10.1093/annonc/mdx289.

family: Dreyling

full_name: M. Dreyling

given: M.

family: Morschhauser

full_name: F. Morschhauser

given: F.

family: Bouabdallah

full_name: K. Bouabdallah

given: K.

family: Bron

full_name: D. Bron

given: D.

family: Cunningham

full_name: D. Cunningham

family: Assouline

full_name: S.E. Assouline

family: Verhoef

full_name: G. Verhoef

given: G.

family: Linton

full_name: K. Linton

family: Thieblemont

full_name: C. Thieblemont

given: C.

family: Vitolo

full_name: U. Vitolo

given: U.

family: Hiemeyer

full_name: F. Hiemeyer

family: Giurescu

full_name: M. Giurescu

family: Garcia-Vargas

full_name: J. Garcia-Vargas

given: J.

family: Gorbatchevsky

full_name: I. Gorbatchevsky

given: I.

full_name: L. Liu

given: L.

family: Koechert

full_name: K. Koechert

family: Peña

full_name: C. Peña

family: Neves

full_name: M. Neves

family: Childs

full_name: B.H. Childs

family: Zinzani

full_name: P.L. Zinzani

journal_name: Annals of Oncology

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
dipot.ulb.ac.be

ReferenceCitation: Panayiotidis P, Follows GA, Mollica L, Nagler A, Özcan M, Santoro A, Stevens D, Trevarthen D, Hiemeyer F, Garcia-Vargas J, Childs BH, Zinzani PL, Dreyling M. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. doi: 10.1182/bloodadvances.2020002910.

name: First Department of Propaedeutic Internal Medicine, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece;

name: Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom;

name: Maisonneuve-Rosemont Hospital Research Centre, Montréal, QC, Canada;

name: Chaim Sheba Medical Center, Tel Aviv University, Tel HaShomer, Israel;

name: Faculty of Medicine, Ankara University, Ankara, Turkey;

name: Humanitas Clinical and Research Center Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Department of Biomedical Sciences, Humanitas University, Rozzano, Italy;

name: Norton Cancer Institute, Louisville, KY;

name: Comprehensive Cancer Care and Research Institute of Colorado, Englewood, CO;

name: Pharmaceutical Division, Bayer AG, Berlin, Germany;

name: Bayer HealthCare Pharmaceuticals, Inc, Whippany, NJ;

name: IRCCS, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy;

name: Istituto di Ematologia “Seràgnoli," Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università degli Studi, Bologna, Italy; and

name: LMU Hospital, Department of Medicine III, Munich, Germany

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
France
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Bulgaria
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Israel
New Zealand
Spain
Turkey


ReferenceCitation: Lugtenburg P, Avivi I, Berenschot H, Ilhan O, Marolleau JP, Nagler A, Rueda A, Tani M, Turgut M, Osborne S, Smith R, Pfreundschuh M. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.

family: Lugtenburg

full_name: Pieternella Lugtenburg

given: Pieternella

family: Avivi

full_name: Irit Avivi

given: Irit

family: Berenschot

full_name: Henriette Berenschot

given: Henriette

family: Ilhan

full_name: Osman Ilhan

given: Osman

family: Marolleau

full_name: Jean Pierre Marolleau

given: Jean Pierre

family: Nagler

full_name: Arnon Nagler

given: Arnon

family: Rueda

full_name: Antonio Rueda

given: Antonio

family: Tani

full_name: Monica Tani

given: Monica

family: Turgut

full_name: Mehmet Turgut

given: Mehmet

family: Osborne

full_name: Stuart Osborne

given: Stuart

family: Smith

full_name: Rodney Smith

given: Rodney

family: Pfreundschuh

full_name: Michael Pfreundschuh

given: Michael

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

license: publisher-specific license

license_normalized: publisher-specific

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

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

location_country:
Peru
Finland
Greece
Belgium
Russian Federation
Ukraine
France
Poland
Thailand
Argentina
Canada
Colombia
South Africa
Saudi Arabia
Netherlands
Bulgaria
Ireland
Algeria
Portugal
United Kingdom
Italy
Brazil
Serbia
Venezuela
Israel
Spain
Turkey

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

location_facility: Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer

location_facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

location_facility: Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

location_facility: Saint-Petersburg SHI City Clinical Hospital #31

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

location_facility: Meander Medisch Centrum; Locatie Lichtenberg

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

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Hospital Universitario Dr. Peset; Servicio de Hematologia

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Regional health authority A vitalite health network

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Swietokrzyskie Centrum Onkologii; Onkologia Ogolna

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Hematología

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

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

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Hospital Costa del Sol; Servicio de Hematologia

location_facility: Shaare Zedek Medical Center; Hematology Dept.

location_facility: Centre ONCOGARD - Institut de Cancerologie du Gard

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

location_facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

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

location_facility: Hospital de Cruces; Servicio de Hematologia

location_facility: Military Medical Academy; Hematology And Oncology

location_facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia

location_facility: University Hospital of Ioannina; Hematology

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Hospital de Sao Joao; Servico de Hematologia Clinica

location_facility: Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde

location_facility: Haemek Medical Center; Hematology Department

location_facility: Clinical Center Kragujevac;Center for Hematology

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

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

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

location_facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: Az. Osp. Sant'Andrea; U.O. C. Ematologia

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

location_facility: Gaziantep Uni Medical School; Hematology

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia

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

location_facility: Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

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

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Maxima Medisch Centrum; Inwendige Geneeskunde

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Tygerberg Hospital; Haematology Department

location_facility: Hospital Lucus Augusti; Servicio de Hematologia

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Periph. University General Hospital of Heraklion; Hematology

location_facility: Ospedale Di Circolo E Fondazione Macchi; Ematologia

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

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

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

location_facility: City Clinical Hospital #15; Hematology department

location_facility: Hospital de Donostia; Servicio de Hematologia

location_facility: University General Hospital of Alexandroupolis; Haemotology

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: St James' Hospital; Cancer Clinical Trials Office

location_facility: Hopital Yves Le Foll; Hematologie Oncologie

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

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

location_facility: Instituto de Oncologia y Hematologia UCV

location_facility: Diskapi Research And Training Hospital; hematology

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku SUM

location_facility: Rus Med Academy for Postgraduate Education; Oncology Department

location_facility: Hospital Punta Europa; Servicio de Hematologia

location_facility: Hia Sainte Anne; Medecine Interne Oncologie

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

location_facility: Theagenio Anticancer Hospital; Dept. of Haematology

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

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

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Erasmus Mc - Locatie Centrum; Dept of Hematology

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

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

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

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Georgios Papanikolaou Hospital; Hematology Department

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

location_facility: Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

title: A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

summary: This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.


title: A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

summary: The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
South Africa
Guatemala
Mexico
Germany
France
Poland
Lithuania
Georgia
Australia
Russian Federation
New Zealand
Spain
Estonia
Canada
Latvia
Ukraine

location_facility: 1276.10.11001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11033 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11041 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11028 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11034 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11015 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11050 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11051 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11017 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11016 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11048 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37202 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11036 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37104 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11024 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11035 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50202 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11047 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11044 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99501 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37102 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11022 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11030 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99503 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11058 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33011 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11031 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37101 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.64002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11040 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.61002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11027 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11026 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99504 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11055 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50203 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11049 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11012 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11043 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37201 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11042 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37204 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11011 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11029 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50205 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99506 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99502 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37103 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11010 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20010 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.61001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11018 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11013 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50201 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11020 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99505 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.64001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37203 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33014 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50204 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49003 Boehringer Ingelheim Investigational Site