title: A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

acronym: ENSURE-AF

summary: The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

ReferenceCitation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

repository_institution: Radboud University - Radboud Repository

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

ReferenceCitation: Goette A, Kwong WJ, Ezekowitz MD, Banach M, Hjortshoj SP, Zamoryakhin D, Lip GYH. Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study. Europace. 2018 Dec 1;20(12):1936-1943. doi: 10.1093/europace/euy141.

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Goette A, Merino JL, Ezekowitz MD, Zamoryakhin D, Melino M, Jin J, Mercuri MF, Grosso MA, Fernandez V, Al-Saady N, Pelekh N, Merkely B, Zenin S, Kushnir M, Spinar J, Batushkin V, de Groot JR, Lip GY; ENSURE-AF investigators. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016 Oct 22;388(10055):1995-2003. doi: 10.1016/S0140-6736(16)31474-X. Epub 2016 Aug 30. Erratum In: Lancet. 2016 Oct 22;388(10055):1984.

ReferenceCitation: Lip GY, Merino J, Ezekowitz M, Ellenbogen K, Zamoryakhin D, Lanz H, Jin J, Al-Saadi N, Mercuri M, Goette A. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart J. 2015 May;169(5):597-604.e5. doi: 10.1016/j.ahj.2015.02.009. Epub 2015 Feb 21.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repositories_concat: Pure (Denmark)

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Poland
Czechia
France
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Bulgaria
Russian Federation
Israel

location_facility:
Bad Friedrichshall
Second site in
First site in
Third site in


study_start_date_type: Actual

acronym: CREDENCE

intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

summary: The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

ReferenceType: derived

ReferenceCitation: Sarraju A, Bakris G, Cannon CP, Cherney D, Damaraju CV, Figtree GA, Gogate J, Greene T, Heerspink HJL, Januzzi JL Jr, Neal B, Jardine MJ, Blais J, Kosiborod M, Levin A, Lingvay I, Weir MR, Perkovic V, Mahaffey KW. Cardiovascular Effects of Canagliflozin in Relation to Renal Function and Albuminuria. J Am Coll Cardiol. 2022 Nov 1;80(18):1721-1731. doi: 10.1016/j.jacc.2022.08.772.

oa_colors: green hybrid

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

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license_normalized: public-domain

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Li JW, Arnott C, Heerspink HJL, MBiostat QL, Cannon CP, Wheeler DC, Charytan DM, Barraclough J, Figtree GA, Agarwal R, Bakris G, de Zeeuw D, Greene T, Levin A, Pollock C, Zhang H, Zinman B, Mahaffey KW, Perkovic V, Neal B, Jardine MJ. Effect of Canagliflozin on Total Cardiovascular Burden in Patients With Diabetes and Chronic Kidney Disease: A Post Hoc Analysis From the CREDENCE Trial. J Am Heart Assoc. 2022 Aug 16;11(16):e025045. doi: 10.1161/JAHA.121.025045. Epub 2022 Aug 5.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

license_normalized: no license

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

license: cc-by

license_normalized: cc-by

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery
pure.rug.nl

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Charytan DM, Yu J, Jardine MJ, Cannon CP, Agarwal R, Bakris G, Greene T, Levin A, Pollock C, Powe NR, Arnott C, Mahaffey KW; CREDENCE study investigators. Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial. Clin J Am Soc Nephrol. 2022 Mar;17(3):361-373. doi: 10.2215/CJN.08980621. Epub 2022 Jan 21.

oa_colors: green other

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repositories_concat: PubMed Central

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ReferenceCitation: Heerspink HJL, Oshima M, Zhang H, Li J, Agarwal R, Capuano G, Charytan DM, Craig J, de Zeeuw D, Di Tanna GL, Levin A, Neal B, Perkovic V, Wheeler DC, Yavin Y, Jardine MJ. Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial. Am J Kidney Dis. 2022 Feb;79(2):244-256.e1. doi: 10.1053/j.ajkd.2021.05.005. Epub 2021 May 23.

oa_host_type: repository

repository_institution: Imperial College London - Spiral

version: submittedVersion

unpaywall_oa_status: green

ReferenceCitation: Zhou Z, Jardine MJ, Li Q, Neuen BL, Cannon CP, de Zeeuw D, Edwards R, Levin A, Mahaffey KW, Perkovic V, Neal B, Lindley RI; CREDENCE Trial Investigators*. Effect of SGLT2 Inhibitors on Stroke and Atrial Fibrillation in Diabetic Kidney Disease: Results From the CREDENCE Trial and Meta-Analysis. Stroke. 2021 May;52(5):1545-1556. doi: 10.1161/STROKEAHA.120.031623. Epub 2021 Apr 20.

evidence: open (via page says license)

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;pure.rug.nl;spiral.imperial.ac.uk

ReferenceCitation: Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.

ReferenceCitation: Jardine M, Zhou Z, Lambers Heerspink HJ, Hockham C, Li Q, Agarwal R, Bakris GL, Cannon CP, Charytan DM, Greene T, Levin A, Li JW, Neuen BL, Neal B, Oh R, Oshima M, Pollock C, Wheeler DC, de Zeeuw D, Zhang H, Zinman B, Mahaffey KW, Perkovic V. Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria: A CREDENCE Secondary Analysis. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):384-395. doi: 10.2215/CJN.15260920. Epub 2021 Feb 22.

ReferenceCitation: Ye N, Jardine MJ, Oshima M, Hockham C, Heerspink HJL, Agarwal R, Bakris G, Schutte AE, Arnott C, Chang TI, Gorriz JL, Cannon CP, Charytan DM, de Zeeuw D, Levin A, Mahaffey KW, Neal B, Pollock C, Wheeler DC, Luca Di Tanna G, Cheng H, Perkovic V, Neuen BL. Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease: Insights From the CREDENCE Trial. Circulation. 2021 May 4;143(18):1735-1749. doi: 10.1161/CIRCULATIONAHA.120.048740. Epub 2021 Feb 8.

ReferenceCitation: Sarraju A, Li J, Cannon CP, Chang TI, Agarwal R, Bakris G, Charytan DM, de Zeeuw D, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Perkovic V, Jardine M, Mahaffey KW. Effects of canagliflozin on cardiovascular, renal, and safety outcomes in participants with type 2 diabetes and chronic kidney disease according to history of heart failure: Results from the CREDENCE trial. Am Heart J. 2021 Mar;233:141-148. doi: 10.1016/j.ahj.2020.12.008. Epub 2020 Dec 22.

ReferenceCitation: Durkin M, Blais J. Linear Projection of Estimated Glomerular Filtration Rate Decline with Canagliflozin and Implications for Dialysis Utilization and Cost in Diabetic Nephropathy. Diabetes Ther. 2021 Feb;12(2):499-508. doi: 10.1007/s13300-020-00953-4. Epub 2020 Dec 18.

ReferenceCitation: Willis M, Nilsson A, Kellerborg K, Ball P, Roe R, Traina S, Beale R, Newell I. Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model. Diabetes Ther. 2021 Jan;12(1):313-328. doi: 10.1007/s13300-020-00968-x. Epub 2020 Dec 2.

ReferenceCitation: Willis M, Asseburg C, Slee A, Nilsson A, Neslusan C. Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data. Diabetes Ther. 2020 Nov;11(11):2657-2676. doi: 10.1007/s13300-020-00923-w. Epub 2020 Sep 15.

ReferenceCitation: Jardine MJ, Zhou Z, Mahaffey KW, Oshima M, Agarwal R, Bakris G, Bajaj HS, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Di Tanna GL, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Qiu R, Sun T, Wheeler DC, Zhang H, Zinman B, Rosenthal N, Perkovic V; CREDENCE Study Investigators. Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial. J Am Soc Nephrol. 2020 May;31(5):1128-1139. doi: 10.1681/ASN.2019111168.

ReferenceCitation: Cannon CP, Perkovic V, Agarwal R, Baldassarre J, Bakris G, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Jardine MJ, Levin A, Li JW, Neal B, Pollock C, Wheeler DC, Zhang H, Zinman B, Mahaffey KW. Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%: Results From the CREDENCE Trial. Circulation. 2020 Feb 4;141(5):407-410. doi: 10.1161/CIRCULATIONAHA.119.044359. Epub 2019 Nov 11. No abstract available.

ReferenceCitation: Mahaffey KW, Jardine MJ, Bompoint S, Cannon CP, Neal B, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Capuano G, de Zeeuw D, Greene T, Levin A, Pollock C, Sun T, Wheeler DC, Yavin Y, Zhang H, Zinman B, Rosenthal N, Brenner BM, Perkovic V. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups. Circulation. 2019 Aug 27;140(9):739-750. doi: 10.1161/CIRCULATIONAHA.119.042007. Epub 2019 Jul 11.

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Jardine MJ, Mahaffey KW, Neal B, Agarwal R, Bakris GL, Brenner BM, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Levin A, Pollock C, Wheeler DC, Xie J, Zhang H, Zinman B, Desai M, Perkovic V; CREDENCE study investigators. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics. Am J Nephrol. 2017 Dec 13;46(6):462-472. doi: 10.1159/000484633. Online ahead of print.

sponsor_collaborators: The George Institute for Global Health, Australia

title: A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
Serbia
France
Lithuania
Colombia
Slovakia
Hungary
United States
Ukraine
India
Romania
China
Malaysia
Puerto Rico
Philippines
Guatemala
United Kingdom
Mexico
United Arab Emirates
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


acronym: LuxLung 5

lead_sponsor: Boehringer Ingelheim

summary: The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

ReferenceCitation: Schuler M, Yang JC, Park K, Kim JH, Bennouna J, Chen YM, Chouaid C, De Marinis F, Feng JF, Grossi F, Kim DW, Liu X, Lu S, Strausz J, Vinnyk Y, Wiewrodt R, Zhou C, Wang B, Chand VK, Planchard D; LUX-Lung 5 Investigators. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial. Ann Oncol. 2016 Mar;27(3):417-23. doi: 10.1093/annonc/mdv597. Epub 2015 Dec 8.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;pure.eur.nl;spiral.imperial.ac.uk

location_facility: Boehringer Ingelheim Investigational Site

status: Completed

title: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
France
Hungary
Ukraine
India
Belgium
China
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Amgen

summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

ReferenceType: background

ReferenceCitation: Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.

ReferenceCitation: Avet-Loiseau H, Fonseca R, Siegel D, Dimopoulos MA, Spicka I, Masszi T, Hajek R, Rosinol L, Goranova-Marinova V, Mihaylov G, Maisnar V, Mateos MV, Wang M, Niesvizky R, Oriol A, Jakubowiak A, Minarik J, Palumbo A, Bensinger W, Kukreti V, Ben-Yehuda D, Stewart AK, Obreja M, Moreau P. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma. Blood. 2016 Sep 1;128(9):1174-80. doi: 10.1182/blood-2016-03-707596. Epub 2016 Jul 20.

ReferenceCitation: Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Ro S, Aggarwal S, Moreau P, Palumbo A. Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. Blood Cancer J. 2017 Apr 21;7(4):e554. doi: 10.1038/bcj.2017.31.

ReferenceCitation: Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, Moreau P. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study. Br J Haematol. 2017 May;177(3):404-413. doi: 10.1111/bjh.14549. Epub 2017 Feb 17.

ReferenceCitation: Jakubowiak AJ, Campioni M, Benedict A, Houisse I, Tichy E, Giannopoulou A, Aggarwal SK, Barber BL, Panjabi S. Cost-effectiveness of adding carfilzomib to lenalidomide and dexamethasone in relapsed multiple myeloma from a US perspective. J Med Econ. 2016 Nov;19(11):1061-1074. doi: 10.1080/13696998.2016.1194278. Epub 2016 Jun 16.

ReferenceCitation: Stewart AK, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Buchanan J, Cocks K, Yang X, Xing B, Zojwalla N, Tonda M, Moreau P, Palumbo A. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921-3930. doi: 10.1200/JCO.2016.66.9648.

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.

ReferenceCitation: Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

ReferenceCitation: Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

ReferenceCitation: Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.

ReferenceCitation: Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

ReferenceCitation: Siegel DS, Dimopoulos MA, Ludwig H, Facon T, Goldschmidt H, Jakubowiak A, San-Miguel J, Obreja M, Blaedel J, Stewart AK. Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 10;36(8):728-734. doi: 10.1200/JCO.2017.76.5032. Epub 2018 Jan 17.

ReferenceCitation: Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.

ReferenceCitation: Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: Massachusetts Medical Society

location_facility: SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Maria Sklodowska-Curie Institute of Oncology

location_facility: University of Szeged, Albert Szent-Gyorgi Clinical Center

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

location_facility: Hospital Universitario y Politeecnico La Fe

location_facility: University Clinical Centre, Department of Hematologii Transplantologii

location_facility: The University of Michigan - Comprehensive Cancer Center

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment

location_facility: Federal State Budget Institution: Hematology Research Center under MoH

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.

location_facility: Nicolaus Copernicus Municipal Specialist Hospital

location_facility: Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin

location_facility: University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main

location_facility: Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie

location_facility: Froedtert & Medical College of Wisconsin

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare

location_facility: General Hospital, Health Sciences Centre

location_facility: Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach

location_facility: Military Medical Academy, Clinic of Hematology

location_facility: University Hospital Brno, Department of Internal Medicine - Hematooncology

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: State Medical Institution Komi Republican Oncological Center

location_facility: Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation

location_facility: Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Clinical Center Nis, Clinic of Hematology

location_facility: Karolinska Universitetsjukhuset i Huddinge

location_facility: FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov

location_facility: The Don & Sybil Harrington Cancer Center

location_facility: University Hospital Kralovske Vinohrady - Prague

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

location_facility: Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare

location_facility: UT Southwestern Medical Center at Dallas

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi"

location_facility: Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

location_facility: Nottingham University Hospitals (City Campus)

location_facility: Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: Azienda Ospedllero Maggiore della Carita

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Sir Mortimer B. Davis - Jewish General Hospital

location_facility: Independent Public Teaching Hospital of Medical University of Silesia in Katowice

location_facility: McGill University Health Center, Royal Victoria Hospital

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

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

title: A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

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


title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

acronym: EinsteinChoice

summary:
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

primary_purpose: Prevention

ReferenceCitation: Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.

ReferenceCitation: Flumignan CD, Nakano LC, Baptista-Silva JC, Flumignan RL. Antiplatelet agents for the treatment of deep venous thrombosis. Cochrane Database Syst Rev. 2022 Jul 25;7(7):CD012369. doi: 10.1002/14651858.CD012369.pub2.

publisher_dissemination: Wiley

ReferenceCitation: Weitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Freitas MCS, Holberg G, Kakkar AK, Haskell L, van Bellen B, Pap AF, Berkowitz SD, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017 Mar 30;376(13):1211-1222. doi: 10.1056/NEJMoa1700518. Epub 2017 Mar 18.

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

repository_institution: King's College London - Research Portal

repository_institution: Université de Lausanne - SERVAL

repositories_institution: University College London - UCL Discovery

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Janssen Scientific Affairs, LLC

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Vietnam
Turkey
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
China
Philippines
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


lead_sponsor: Novartis Pharmaceuticals

summary:
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

ReferenceCitation: San-Miguel JF, Einsele H, Moreau P. The Role of Panobinostat Plus Bortezomib and Dexamethasone in Treating Relapsed or Relapsed and Refractory Multiple Myeloma: A European Perspective. Adv Ther. 2016 Nov;33(11):1896-1920. doi: 10.1007/s12325-016-0413-7. Epub 2016 Sep 27.

repository_institution: Würzburg University - Online Publication Service of Würzburg University

publisher_dissemination: Springer-Nature

ReferenceCitation: San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Binlich F, Richardson PG. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Nov;3(11):e506-e515. doi: 10.1016/S2352-3026(16)30147-8. Epub 2016 Oct 14.

oa_host_type: closed

ReferenceCitation: Richardson PG, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Guenther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Corrado C, Binlich F, San-Miguel JF. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment. Blood. 2016 Feb 11;127(6):713-21. doi: 10.1182/blood-2015-09-665018. Epub 2015 Dec 2. Erratum In: Blood. 2016 Jun 30;127(26):3460.

publisher_dissemination: American Society of Hematology

ReferenceCitation: San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Corradini P, Chuncharunee S, Lee JJ, Schlossman RL, Shelekhova T, Yong K, Tan D, Numbenjapon T, Cavenagh JD, Hou J, LeBlanc R, Nahi H, Qiu L, Salwender H, Pulini S, Moreau P, Warzocha K, White D, Blade J, Chen W, de la Rubia J, Gimsing P, Lonial S, Kaufman JL, Ocio EM, Veskovski L, Sohn SK, Wang MC, Lee JH, Einsele H, Sopala M, Corrado C, Bengoudifa BR, Binlich F, Richardson PG. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1195-206. doi: 10.1016/S1470-2045(14)70440-1. Epub 2014 Sep 18. Erratum In: Lancet Oncol. 2015 Jan;16(1):e6.

title: A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Hong Kong
Denmark
United States
Lebanon
Belgium
China
Egypt
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

evidence: open (via free pdf)

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Diabetes Association

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_facility: 1245.33.44002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01042 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01062 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44009 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01014 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01020 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01044 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01023 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01028 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01040 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35303 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01016 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01013 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01022 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01011 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01025 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01043 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01048 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01049 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01024 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01050 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35304 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35302 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01027 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3308A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35107 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01029 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01031 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35102 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01019 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01061 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01035 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01010 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01026 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01012 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01018 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01037 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35101 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01045 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01017 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01054 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01041 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01038 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01032 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01009 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01051 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01056 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45011 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01036 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01046 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01059 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35106 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35104 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01033 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01058 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44010 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01047 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01060 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01055 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45013 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01015 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01030 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01003 Boehringer Ingelheim Investigational Site

title: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

location_country:
Ireland
Portugal
United Kingdom
Denmark
United States
Korea, Republic of
France


lead_sponsor: Abbott

summary: The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

ReferenceCitation: Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.

version: acceptedVersion

repository_institution: University of Cambridge - Apollo

repositories:
PubMed Central
Pure (Denmark)
www.repository.cam.ac.uk

repositories_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, Kudo M, Kang YK, Chen PJ, Toh HC, Gorbunova V, Eskens FA, Qian J, McKee MD, Ricker JL, Carlson DM, El-Nowiem S. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015 Jan 10;33(2):172-9. doi: 10.1200/JCO.2013.54.3298. Epub 2014 Dec 8. Erratum In: J Clin Oncol. 2017 Aug 1;35(22):2590.

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility:
Site Reference ID/Investigator# 23425
Site Reference ID/Investigator# 23194
Site Reference ID/Investigator# 43444
Site Reference ID/Investigator# 23842
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status: Terminated

title: An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

location_country:
Germany
New Zealand
Argentina
Australia
Japan
Chile
Canada
France
Czech Republic
Hong Kong
Denmark
United States
Romania
Belgium
China
Malaysia
Puerto Rico
Egypt
Italy
Norway
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

status_simplified: Unknown


title: A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies

summary: The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

design_allocation: Non-Randomized

ipd_sharing: No

location_country:
Germany
Italy
Israel
Singapore
Australia
Netherlands
Austria
United States
Korea, Republic of
Spain
Thailand
Turkey
Taiwan
France

location_facility: Thomas Jefferson University Hospital Onc Dept

location_facility: University of Colorado Dept. of Anschutz Cancer (3)

location_facility: Memorial Sloan Kettering Cancer Center Onc. Dept..


summary: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

ReferenceCitation: Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7.

location_facility: 1218.61.01027 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3312A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63002 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01023 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01017 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01031 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01028 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01001 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01046 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3311A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01030 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3313A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01009 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01005 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3309A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01043 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01048 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01020 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01008 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91005 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01040 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3310A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01014 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01042 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01024 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01007 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01053 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01015 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01006 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01018 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01049 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01052 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01044 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01016 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91007 Boehringer Ingelheim Investigational Site

title: A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone

location_country:
United States
India
Philippines
France


acronym: LUX-Lung 3

summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

ReferenceCitation: Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

repository_institution: Queensland University of Technology - QUT ePrints

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

ReferenceCitation: Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Marten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. doi: 10.1093/annonc/mdw322. Epub 2016 Sep 6.

ReferenceCitation: Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.

ReferenceCitation: Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.

ReferenceCitation: Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.

ReferenceCitation: Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.

ReferenceCitation: Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.

ReferenceCitation: Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.

location_facility: Lviv State Oncological Regional Treatment & Diagnostic CTR

location_facility: Hospital Dirección de Previsión de Carabineros

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Instituto Clínico Oncológico del Sur - ICOS

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Republic Clinical Oncology Dispensary, Dept. Chemotherapy

location_facility: First Pavlov State Medical University Saint Petersburg

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Cross Cancer Institute (University of Alberta)

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Pusat Perubatan University Kebangsaan Malaysia

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Instituto Oncológico Limitada Viña del Mar

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: FSBSI "N.N Blokhin Medical Research Center of Oncology"

location_facility: Universitätsklinikum Benjamin Franklin, Berlin

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Centro de Pesquisas Clínicas em Oncología

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: UNIFESP Departamento de Medicina de Pneumologia

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Clinical Trials and Research Associates Inc

location_facility: City Clinical Hospital #4, Dnipropetrovsk State Medical Academy

location_facility: Innovative Medical Research of South Florida

location_facility: Hospital São Lucas da Pontifícia Universidade Católica

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: Centro de Pesquisa do Hospital Lifecenter

location_facility: McGill University, Department of Oncology

location_facility: Instituto de Medicina Nuclear de Bahía Blanca

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hematologiste et oncologue medical CHUM - Hopital Notre-Dame

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

location_facility: Lehigh Valley Hospital / Lehigh Valley Health Network

location_facility: Markusovszky County Hospital, Szombathely

location_facility: South Texas Institute of Cancer, Northwest Cancer Center

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Canada
France
Hungary
Hong Kong
United States
Ukraine
Romania
Belgium
Malaysia
Peru
Philippines
Italy
United Kingdom
Austria
Korea, Republic of
Taiwan
Russian Federation


acronym: PROSPER

lead_sponsor: Pfizer

summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

ReferenceCitation: De Giorgi U, Hussain M, Shore N, Fizazi K, Tombal B, Penson D, Saad F, Efstathiou E, Madziarska K, Steinberg J, Sugg J, Lin X, Shen Q, Sternberg CN. Which traits affect how long patients with advanced prostate cancer live when treated with enzalutamide? Future Oncol. 2022 Nov;18(35):3867-3874. doi: 10.2217/fon-2022-0661. Epub 2022 Oct 13.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

ReferenceCitation: Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.

ReferenceCitation: De Giorgi U, Hussain M, Shore N, Fizazi K, Tombal B, Penson D, Saad F, Efstathiou E, Madziarska K, Steinberg J, Sugg J, Lin X, Shen Q, Sternberg CN. Consistent survival benefit of enzalutamide plus androgen deprivation therapy in men with nonmetastatic castration-resistant prostate cancer: PROSPER subgroup analysis by age and region. Eur J Cancer. 2021 Dec;159:237-246. doi: 10.1016/j.ejca.2021.10.015. Epub 2021 Nov 14.

ReferenceCitation: Saad F, Sternberg CN, Efstathiou E, Fizazi K, Modelska K, Lin X, Sugg J, Steinberg J, Noerby B, Shore ND, Hussain M. Prostate-specific Antigen Progression in Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer: Any Rise in Prostate-specific Antigen May Require Closer Monitoring. Eur Urol. 2020 Dec;78(6):847-853. doi: 10.1016/j.eururo.2020.08.025. Epub 2020 Oct 1.

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

ReferenceCitation: Sternberg CN, Fizazi K, Saad F, Shore ND, De Giorgi U, Penson DF, Ferreira U, Efstathiou E, Madziarska K, Kolinsky MP, Cubero DIG, Noerby B, Zohren F, Lin X, Modelska K, Sugg J, Steinberg J, Hussain M; PROSPER Investigators. Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2197-2206. doi: 10.1056/NEJMoa2003892. Epub 2020 May 29.

ReferenceCitation: Tombal B, Saad F, Penson D, Hussain M, Sternberg CN, Morlock R, Ramaswamy K, Ivanescu C, Attard G. Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Apr;20(4):556-569. doi: 10.1016/S1470-2045(18)30898-2. Epub 2019 Feb 12.

repositories_concat: UCL Discovery

ReferenceCitation: Hussain M, Fizazi K, Saad F, Rathenborg P, Shore N, Ferreira U, Ivashchenko P, Demirhan E, Modelska K, Phung D, Krivoshik A, Sternberg CN. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2018 Jun 28;378(26):2465-2474. doi: 10.1056/NEJMoa1800536.

sponsor_collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

location_facility: Kyiv City Clinical Hospital #3, Department of Urology

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"

location_facility: Farmacia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga

location_facility: Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of Urology

location_facility: Vzw Algemeen Ziekenhuis Maria Middelares

location_facility: Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)

location_facility: Central City Clinical Hospital, City Oncological Center

location_facility: University of California, Irvine Medical Center

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Krankenhaus Barmherzige Schwestern Linz, Abteilung Radiologie

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Integrated Clinical Oncology Network (ICON)

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson

location_facility: UROEXAM spol. s r.o. urologicka ambulancia

location_facility: Urological Associates of Southern Arizona, PC

location_facility: Vanderbilt University Medical Center, Dept. of Urologic Surgery

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: U.O. di Oncologia Medica, Ospedale Santa Chiara

location_facility: Fakultna nemocnica s Poliklinikou Skalica a.s

location_facility: Chonnam National University Hwasun Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: SBHI "Saint-Petersburg clinical scientific

location_facility: GAMMALAB, spol.s.r.o., Oddelenie nuklearnej mediciny

location_facility: U.O. di Oncologia, Ospedale Civile Umberto I

location_facility: CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut nuklearnej a molekularnej mediciny

location_facility: Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat Heidelberg

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

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Universiti Kebangsaan Malaysia Medical Centre

location_facility: Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: CI Dnipropetrovsk I.I. Mechnykov RCH, Department of Urology #2

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Epic Pharmacy Port Macquarie base hospital

location_facility: Premier Medical Group of the Hudson Valley

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

location_facility: Helsingin yliopistollinen keskussairaala, Meilahden sairaala

location_facility: Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP

location_facility: UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSR

location_facility: IAMSPE-Inst. de Assist. ao Servidor Publico Estadual

location_facility: Hospital Universitario Pedro Ernesto - UERJ

location_facility: Clinical Center "Bezanijska Kosa", Department of Urology

location_facility: COIBA(Centro de Oncologia e Investigacion Buenos Aires)

location_facility: Institut de Cancerologie de I'Ouest - Rene Gauducheau

location_facility: GAMMALAB, spol. s.r.o., Oddelenie nuklearnej mediciny

location_facility: C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-Pierantoni

location_facility: Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: GU Research Network/ Wichita Urology Group

location_facility: Institut de Cancerologie de l'Ouest - Paul Papin

location_facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Bratislavske radiodiagnosticke centrum, a.s.

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Servizio Farmacia, Istituto Europeo di Oncologia

location_facility: The Male/Female Health and Research Centre

location_facility: Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbH

location_facility: Qingdao Municipal Hospital (East Hospital)

location_facility: Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Clinique Pasteur- Service Imagerie et Radiologie

location_facility: Cabrini Hospital- Education and Research Precinct

location_facility: Diagnostiskt centrum for bild- och funktionsmedicin

location_facility: U.O. di Medicina Nucleare e Centro PET, Ospedale San Raffaele

location_facility: Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Farmacia Ospedaliera, AOU San Luigi Gonzaga

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: State Budgetary Healthcare Institution City Multifield Hospital No.2

location_facility: SS Medicina Nucleare, AOU San Luigi Gonzaga

location_facility: U.O. di Radiologia, Ospedale Civile Umberto I

location_facility: Medicina Nucleare, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,

location_facility: King Chulalongkorn Memorial Hospital, Chulalongkorn University

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"

location_facility: Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)

location_facility: ICO Girona-Hospital Universitari de Girona Dr. Josep Trueta

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Servizio di Farmacia, Ospedale San Raffaele

location_facility: McMaster Institute of Urology @ St. Joseph's Healthcare Hamilton

location_facility: Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di Oncologia

location_facility: P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research

location_facility: The First Affiliated Hosptial of Wenzhou Medical University

location_facility: Apoteket AB Kliniska Provningar Molnlycke

location_facility: Urology Associates of San Luis Obispo, a Medical Group, Inc

location_facility: Radboud University Nijmegen Medical Centre

location_facility: University General Hospital of Patras, Oncology Department, Internal Medicine Clinic

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Manitoba Prostate Centre CancerCare Manitoba

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza. Korczaka

location_facility: University General Hospital of Heraklion, Urology Clinic

location_facility: Izmir Bozyaka Egitim Arastirma Hastanesi

location_facility: Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenie

location_facility: S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Medicina Nucleare, Istituto Oncologico Veneto (IOV)

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Eastern Clinical Research Unit (Eastern Health)

location_facility: U.O. di Radiologia, Ospedale Civile degli Infermi

location_facility: Urology Associates / Urologic Medical Research

location_facility: Farmacia, Istituto Oncologico Veneto (IOV)

location_facility: London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)

location_facility: IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: University General Hospital of Larissa, Urology Department

location_facility: CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.

location_facility: Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin I

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)

location_facility: S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)

location_facility: Isotopix, Ambulatorium fuer Nuklearmedizin

location_facility: ALTAHIA. Xarxa Assistencial Universitaria de Manresa

location_facility: SCDU Radiodiagnostica, AOU San Luigi Gonzaga

location_facility: Clinique Universitaire de Bruxelles Hopital Erasme

location_facility: Dipartimento di Radiologia, Ospedale San Raffaele

location_facility: Krankenhaus Barmherzige Schwestern Linz, Abteilung Urologie

location_facility: NS Health Authority, Queen Elizabeth II Health Sciences Centre

location_facility: Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: General Hospital of Athens"Korgialeneio-Benakeio EES".Urology Clinic

location_facility: General Hospital" Papageorgiou",B' Univ.Urology Clinic

location_facility: Vanderbilt University Medical Center, The Urologic Clinic

location_facility: General Hospital of Athens "Alexandra", Therapeutic Clinic

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hospital Amaral Carvalho - Fundacao Dr. Amaral Carvalho

location_facility: Smilow Cancer Center at Yale New Haven-Hospital

location_facility: Centre Regional de lutte Contre le Cancer Georges Francois Leclerc

location_facility: Divisione di Radiologia, Istituto Europeo di Oncologia

location_facility: U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"

location_facility: U.O. di Oncologia, Ospedale Civile Degli Infermi

location_facility: Centre Hospitalier Universitaire de Liege, Site du Sart-Tilman

location_facility: University Health Network- Princess Margaret Cancer Centre

location_facility: Liga Paranaense de Combate ao cancer / Hospital Erasto Gaertner

location_facility: RCI Chernivtsi Regional Clinical Hospital

location_facility: Clinical Center Of Serbia, Clinic of Urology

location_facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)

location_facility: Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le Cancer

title: PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

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

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Turkey
Chile
Canada
Serbia
France
Slovakia
Hong Kong
Denmark
United States
Ukraine
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden

collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.


title: An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities

summary: This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

lead_sponsor: Hoffmann-La Roche

collaborators:
German CLL Study Group
Genentech, Inc.

sponsor_collaborators:
Hoffmann-La Roche
German CLL Study Group
Genentech, Inc.

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Croatia
Czechia
Canada
France
Slovakia
Hong Kong
Denmark
Switzerland
United States
Romania
Estonia
Egypt
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation


acronym: SOCRATES

lead_sponsor: AstraZeneca

summary: The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).

ReferenceCitation: Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.

ReferenceCitation: Evans SR, Knutsson M, Amarenco P, Albers GW, Bath PM, Denison H, Ladenvall P, Jonasson J, Easton JD, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC. Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial. Clin Trials. 2020 Dec;17(6):617-626. doi: 10.1177/1740774520941441. Epub 2020 Jul 15.

publisher_dissemination: SAGE Publications

ReferenceCitation: Cucchiara B, George DK, Kasner SE, Knutsson M, Denison H, Ladenvall P, Amarenco P, Johnston SC. Disability after minor stroke and TIA: A secondary analysis of the SOCRATES trial. Neurology. 2019 Aug 13;93(7):e708-e716. doi: 10.1212/WNL.0000000000007936. Epub 2019 Jul 11.

ReferenceCitation: Easton JD, Denison H, Evans SR, Knutsson M, Amarenco P, Albers GW, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC; SOCRATES Steering Committee and Investigators. Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial. Int J Stroke. 2019 Dec;14(9):908-914. doi: 10.1177/1747493019851282. Epub 2019 May 15.

ReferenceCitation: Molina CA, Johnston SC, Ladenvall P, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Knutsson M, Minematsu K, Rother J, Wang Y, Wong KSL; SOCRATES Steering Committee and Investigators. Time to Loading Dose and Risk of Recurrent Events in the SOCRATES Trial. Stroke. 2019 Mar;50(3):675-682. doi: 10.1161/STROKEAHA.118.022675. Erratum In: Stroke. 2019 Apr;50(4):e118.

ReferenceCitation: Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor Versus Aspirin in Acute Embolic Stroke of Undetermined Source. Stroke. 2017 Sep;48(9):2480-2487. doi: 10.1161/STROKEAHA.117.017217. Epub 2017 Jul 18.

ReferenceCitation: Easton JD, Aunes M, Albers GW, Amarenco P, Bokelund-Singh S, Denison H, Evans SR, Held P, Jahreskog M, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Circulation. 2017 Sep 5;136(10):907-916. doi: 10.1161/CIRCULATIONAHA.117.028566. Epub 2017 Jun 27.

ReferenceCitation: Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and safety of ticagrelor versus aspirin in acute stroke or transient ischaemic attack of atherosclerotic origin: a subgroup analysis of SOCRATES, a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Apr;16(4):301-310. doi: 10.1016/S1474-4422(17)30038-8. Epub 2017 Feb 23.

ReferenceCitation: Wang Y, Minematsu K, Wong KS, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Molina CA, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Stroke. 2017 Jan;48(1):167-173. doi: 10.1161/STROKEAHA.116.014891. Epub 2016 Nov 29.

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.

ReferenceCitation: Johnston SC, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KS; SOCRATES Steering Committee and Investigators. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Jul 7;375(1):35-43. doi: 10.1056/NEJMoa1603060. Epub 2016 May 10.

title: A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
Switzerland
United States
Ukraine
Romania
Belgium
China
Peru
Philippines
Italy
Sweden
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


acronym: THEMIS

summary: The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

ReferenceCitation: Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstrale W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalan R, Cornel JH, Widimsky P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.

ReferenceCitation: Bhatt DL, Steg PG, Mehta SR, Leiter LA, Simon T, Fox K, Held C, Andersson M, Himmelmann A, Ridderstrale W, Chen J, Song Y, Diaz R, Goto S, James SK, Ray KK, Parkhomenko AN, Kosiborod MN, McGuire DK, Harrington RA; THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019 Sep 28;394(10204):1169-1180. doi: 10.1016/S0140-6736(19)31887-2. Epub 2019 Sep 1.

ReferenceCitation: Bhatt DL, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Andersson M, Himmelmann A, Ridderstrale W, Held C, Steg PG; THEMIS Steering Committee. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study. Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9.

ReferenceCitation: Abtan J, Bhatt DL, Elbez Y, Ducrocq G, Goto S, Smith SC Jr, Ohman EM, Eagle KA, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Petrov I, Sinnaeve PR, Pais P, Lev E, Bueno H, Wilson P, Steg PG; REACH Registry Investigators. External applicability of the Effect of ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) trial: An analysis of patients with diabetes and coronary artery disease in the REduction of Atherothrombosis for Continued Health (REACH) registry. Int J Cardiol. 2023 Jan 1;370:51-57. doi: 10.1016/j.ijcard.2022.10.132. Epub 2022 Oct 19.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Wittbrodt E, Bhalla N, Sundell KA, Hunt P, Wong ND, Kuster M, Mellstrom C. Assessment of The High risk and unmEt Need in patients with CAD and type 2 diabetes (ATHENA): US healthcare resource use, cost, and burden of illness in a commercially insured population. J Diabetes Complications. 2021 Apr;35(4):107859. doi: 10.1016/j.jdiacomp.2021.107859. Epub 2021 Jan 20.

title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
United States
Ukraine
India
Romania
Belgium
China
Peru
Puerto Rico
Philippines
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

summary: The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

ReferenceCitation: Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.

publisher_dissemination: Informa

ReferenceCitation: Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

repository_institution: University of Zaragoza Repository - Zaguan

repositories_concat: PubMed Central;zaguan.unizar.es

location_country:
Germany
Ireland
Poland
Czechia
France
Slovenia
Lithuania
Portugal
Slovakia
Hungary
Denmark
Latvia
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Austria
Spain
Greece
Russian Federation
Sweden