ReferenceCitation: Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Køber LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.

ReferenceCitation: Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.

family: Pfeffer

full_name: Marc A. Pfeffer

given: Marc A.

family: Claggett

full_name: Brian Claggett

given: Brian

family: Diaz

full_name: Rafael Diaz

given: Rafael

family: Dickstein

full_name: Kenneth Dickstein

given: Kenneth

family: Gerstein

full_name: Hertzel C. Gerstein

given: Hertzel C.

family: Køber

full_name: Lars V. Køber

given: Lars V.

family: Lawson

full_name: Francesca C. Lawson

given: Francesca C.

family: Ping

full_name: Lin Ping

given: Lin

family: Wei

full_name: Xiaodan Wei

given: Xiaodan

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Probstfield

full_name: Jeffrey L. Probstfield

given: Jeffrey L.

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

full_name: Scott D. Solomon

given: Scott D.

family: Tardif

full_name: Jean-Claude Tardif

given: Jean-Claude

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Wijkman MO, Claggett B, Diaz R, Gerstein HC, Køber L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.

family: Wijkman

full_name: Magnus O. Wijkman

given: Magnus O.

ReferenceCitation: Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.

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

name: University of Texas Health Science Center  Houston TX USA

name: Estudios Clínicos Latinoamérica  Rosario Argentina

name: University of Bergen, Stavanger University Hospital  Stavanger Norway

name: Department of Medicine and Population Health Research Institute McMaster University and Hamilton Health Sciences  Ontario Canada

name: Rigshospitalet Copenhagen University Hospital  Copenhagen Denmark

name: Research Center of the Italian Association of Hospital Cardiologists  Florence Italy

name: British Heart Foundation Cardiovascular Research Centre University of Glasgow  Glasgow UK

name: University of Washington Medical Center  Seattle WA USA

name: Oregon Health and Science University  Portland OR USA

name: Montreal Heart Institute, Université de Montréal  Montreal Canada

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Køber LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.

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

name: Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

name: Estudios Clínicos Latinoamérica, Rosario, Argentina

name: McMaster University, Hamilton, ON, Canada

name: Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark

name: Research Center of the Italian Association of Hospital Cardiologists, Florence, Italy

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK

name: University of Washington Medical Center, Seattle, WA, USA

name: Oregon Health and Science University, Portland, OR, USA

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

repository_institution: Australian Catholic University - Research Bank

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

ReferenceCitation: Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Køber L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6). pii: e004743. doi: 10.1161/JAHA.116.004743.

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

name: Department of Cardiology, Rigshospitalet, Copenhagen, Denmark

name: University of Bergen Stavanger University Hospital, Stavanger, Norway

name: Division of Endocrinology & Metabolism, McMaster University, Hamilton, Ontario, Canada

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom

name: Division of Cardiology, University of Washington Medical Center, Seattle, WA

name: Division of Endocrinology, Oregon Health and Science University, Portland, OR

journal_name: Journal of the American Heart Association

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

title: Role of B‐Type Natriuretic Peptide and N‐Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus

ReferenceCitation: Wohlfart P, Linz W, Hübschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.

repository_institution: University of Dundee - Discovery Research Portal

location_country:
Peru
Guatemala
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Ecuador
India
Spain
France
Japan
Lithuania
Panama
Poland
Norway
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
United Arab Emirates
Switzerland
Netherlands
Philippines
Bulgaria
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Georgia
Tunisia
Egypt
Belarus
Estonia
Latvia

location_facility:
Investigational Site Number 484022
Investigational Site Number 376003
Investigational Site Number 124007
Investigational Site Number 380013
Investigational Site Number 840061
Investigational Site Number 152018
Investigational Site Number 826021
Investigational Site Number 840585
Investigational Site Number 158005
Investigational Site Number 840564
Investigational Site Number 100002
Investigational Site Number 710002
Investigational Site Number 788002
Investigational Site Number 804003
Investigational Site Number 840536
Investigational Site Number 840633
Investigational Site Number 320011
Investigational Site Number 642012
Investigational Site Number 380019
Investigational Site Number 840150
Investigational Site Number 840348
Investigational Site Number 752004
Investigational Site Number 840631
Investigational Site Number 840056
Investigational Site Number 170009
Investigational Site Number 076003
Investigational Site Number 591001
Investigational Site Number 156032
Investigational Site Number 356020
Investigational Site Number 792002
Investigational Site Number 156006
Investigational Site Number 710004
Investigational Site Number 840351
Investigational Site Number 428002
Investigational Site Number 392013
Investigational Site Number 643028
Investigational Site Number 643055
Investigational Site Number 840309
Investigational Site Number 840621
Investigational Site Number 124003
Investigational Site Number 156019
Investigational Site Number 620006
Investigational Site Number 440006
Investigational Site Number 056001
Investigational Site Number 840432
Investigational Site Number 840007
Investigational Site Number 320006
Investigational Site Number 826040
Investigational Site Number 840497
Investigational Site Number 840343
Investigational Site Number 233005
Investigational Site Number 392019
Investigational Site Number 608003
Investigational Site Number 840205
Investigational Site Number 528005
Investigational Site Number 840009
Investigational Site Number 170026
Investigational Site Number 320001
Investigational Site Number 032020
Investigational Site Number 376006
Investigational Site Number 032050
Investigational Site Number 752011
Investigational Site Number 036009
Investigational Site Number 428007
Investigational Site Number 643002
Investigational Site Number 840582
Investigational Site Number 032054
Investigational Site Number 840001
Investigational Site Number 124021
Investigational Site Number 076019
Investigational Site Number 604013
Investigational Site Number 840395
Investigational Site Number 076002
Investigational Site Number 840533
Investigational Site Number 840430
Investigational Site Number 604018
Investigational Site Number 276024
Investigational Site Number 642030
Investigational Site Number 643009
Investigational Site Number 788001
Investigational Site Number 840266
Investigational Site Number 643048
Investigational Site Number 840217
Investigational Site Number 788003
Investigational Site Number 840439
Investigational Site Number 036015
Investigational Site Number 356014
Investigational Site Number 840281
Investigational Site Number 840493
Investigational Site Number 840393
Investigational Site Number 840519
Investigational Site Number 170014
Investigational Site Number 643026
Investigational Site Number 840162
Investigational Site Number 643031
Investigational Site Number 032058
Investigational Site Number 643057
Investigational Site Number 604014
Investigational Site Number 643020
Investigational Site Number 170025
Investigational Site Number 840037
Investigational Site Number 152020
Investigational Site Number 643030
Investigational Site Number 840382
Investigational Site Number 840484
Investigational Site Number 826044
Investigational Site Number 233002
Investigational Site Number 840698
Investigational Site Number 380010
Investigational Site Number 076024
Investigational Site Number 076020
Investigational Site Number 591004
Investigational Site Number 840314
Investigational Site Number 032065
Investigational Site Number 320004
Investigational Site Number 152041
Investigational Site Number 076012
Investigational Site Number 840511
Investigational Site Number 642019
Investigational Site Number 840212
Investigational Site Number 643049
Investigational Site Number 840470
Investigational Site Number 792004
Investigational Site Number 710008
Investigational Site Number 840578
Investigational Site Number 840318
Investigational Site Number 276011
Investigational Site Number 840456
Investigational Site Number 380002
Investigational Site Number 484031
Investigational Site Number 643044
Investigational Site Number 643052
Investigational Site Number 100015
Investigational Site Number 152010
Investigational Site Number 840184
Investigational Site Number 440003
Investigational Site Number 276020
Investigational Site Number 643054
Investigational Site Number 032027
Investigational Site Number 826006
Investigational Site Number 840681
Investigational Site Number 608008
Investigational Site Number 840506
Investigational Site Number 840543
Investigational Site Number 724013
Investigational Site Number 032043
Investigational Site Number 152038
Investigational Site Number 688004
Investigational Site Number 032049
Investigational Site Number 440002
Investigational Site Number 484007
Investigational Site Number 152015
Investigational Site Number 840178
Investigational Site Number 032017
Investigational Site Number 616005
Investigational Site Number 840107
Investigational Site Number 392027
Investigational Site Number 484016
Investigational Site Number 484002
Investigational Site Number 826033
Investigational Site Number 032040
Investigational Site Number 804007
Investigational Site Number 826009
Investigational Site Number 376008
Investigational Site Number 840119
Investigational Site Number 032034
Investigational Site Number 840449
Investigational Site Number 840401
Investigational Site Number 840551
Investigational Site Number 112003
Investigational Site Number 840487
Investigational Site Number 152035
Investigational Site Number 032022
Investigational Site Number 124028
Investigational Site Number 040001
Investigational Site Number 643041
Investigational Site Number 156013
Investigational Site Number 688003
Investigational Site Number 156016
Investigational Site Number 840413
Investigational Site Number 268004
Investigational Site Number 826011
Investigational Site Number 642029
Investigational Site Number 643003
Investigational Site Number 380014
Investigational Site Number 840560
Investigational Site Number 616007
Investigational Site Number 604016
Investigational Site Number 170008
Investigational Site Number 604007
Investigational Site Number 840299
Investigational Site Number 616032
Investigational Site Number 840672
Investigational Site Number 528001
Investigational Site Number 233004
Investigational Site Number 840702
Investigational Site Number 156024
Investigational Site Number 380016
Investigational Site Number 112001
Investigational Site Number 410006
Investigational Site Number 840164
Investigational Site Number 643022
Investigational Site Number 724015
Investigational Site Number 643019
Investigational Site Number 840223
Investigational Site Number 100003
Investigational Site Number 246010
Investigational Site Number 643010
Investigational Site Number 724011
Investigational Site Number 356028
Investigational Site Number 724001
Investigational Site Number 156022
Investigational Site Number 804002
Investigational Site Number 792011
Investigational Site Number 840352
Investigational Site Number 643024
Investigational Site Number 643017
Investigational Site Number 840480
Investigational Site Number 032055
Investigational Site Number 643025
Investigational Site Number 380005
Investigational Site Number 040002
Investigational Site Number 620003
Investigational Site Number 710025
Investigational Site Number 840415
Investigational Site Number 840499
Investigational Site Number 152011
Investigational Site Number 792012
Investigational Site Number 410008
Investigational Site Number 643034
Investigational Site Number 616031
Investigational Site Number 076013
Investigational Site Number 152040
Investigational Site Number 276022
Investigational Site Number 410012
Investigational Site Number 752012
Investigational Site Number 158004
Investigational Site Number 276003
Investigational Site Number 840093
Investigational Site Number 840121
Investigational Site Number 032012
Investigational Site Number 276021
Investigational Site Number 792015
Investigational Site Number 840213
Investigational Site Number 484041
Investigational Site Number 710014
Investigational Site Number 688007
Investigational Site Number 840045
Investigational Site Number 840042
Investigational Site Number 428003
Investigational Site Number 250002
Investigational Site Number 604010
Investigational Site Number 032019
Investigational Site Number 484026
Investigational Site Number 710015
Investigational Site Number 840313
Investigational Site Number 643056
Investigational Site Number 826005
Investigational Site Number 840335
Investigational Site Number 643058
Investigational Site Number 840303
Investigational Site Number 840219
Investigational Site Number 032029
Investigational Site Number 380023
Investigational Site Number 840131
Investigational Site Number 826042
Investigational Site Number 620005
Investigational Site Number 642013
Investigational Site Number 688005
Investigational Site Number 124016
Investigational Site Number 428005
Investigational Site Number 826048
Investigational Site Number 840295
Investigational Site Number 032036
Investigational Site Number 840262
Investigational Site Number 032009
Investigational Site Number 826027
Investigational Site Number 756003
Investigational Site Number 376009
Investigational Site Number 826019
Investigational Site Number 840694
Investigational Site Number 840606
Investigational Site Number 152024
Investigational Site Number 156005
Investigational Site Number 804004
Investigational Site Number 156008
Investigational Site Number 356025
Investigational Site Number 840625
Investigational Site Number 724005
Investigational Site Number 840642
Investigational Site Number 124026
Investigational Site Number 840640
Investigational Site Number 356012
Investigational Site Number 643023
Investigational Site Number 528008
Investigational Site Number 380012
Investigational Site Number 840471
Investigational Site Number 724012
Investigational Site Number 156001
Investigational Site Number 152032
Investigational Site Number 643045
Investigational Site Number 158008
Investigational Site Number 376010
Investigational Site Number 840573
Investigational Site Number 840411
Investigational Site Number 233001
Investigational Site Number 170017
Investigational Site Number 380001
Investigational Site Number 840091
Investigational Site Number 840307
Investigational Site Number 484017
Investigational Site Number 826039
Investigational Site Number 826052
Investigational Site Number 428001
Investigational Site Number 608007
Investigational Site Number 643001
Investigational Site Number 840170
Investigational Site Number 276019
Investigational Site Number 591003
Investigational Site Number 642009
Investigational Site Number 642031
Investigational Site Number 840431
Investigational Site Number 840613
Investigational Site Number 840135
Investigational Site Number 591002
Investigational Site Number 608009
Investigational Site Number 724022
Investigational Site Number 840639
Investigational Site Number 170003
Investigational Site Number 643033
Investigational Site Number 840337
Investigational Site Number 356029
Investigational Site Number 250011
Investigational Site Number 484008
Investigational Site Number 032023
Investigational Site Number 826020
Investigational Site Number 826049
Investigational Site Number 484006
Investigational Site Number 840636
Investigational Site Number 152037
Investigational Site Number 076015
Investigational Site Number 170021
Investigational Site Number 724014
Investigational Site Number 380006
Investigational Site Number 804006
Investigational Site Number 124006
Investigational Site Number 356034
Investigational Site Number 528007
Investigational Site Number 840473
Investigational Site Number 688006
Investigational Site Number 076014
Investigational Site Number 826046
Investigational Site Number 076023
Investigational Site Number 604015
Investigational Site Number 840308
Investigational Site Number 152019
Investigational Site Number 076005
Investigational Site Number 250006
Investigational Site Number 840361
Investigational Site Number 158006
Investigational Site Number 840094
Investigational Site Number 840174
Investigational Site Number 840258
Investigational Site Number 152031
Investigational Site Number 840555
Investigational Site Number 643008
Investigational Site Number 642007
Investigational Site Number 710023
Investigational Site Number 840293
Investigational Site Number 840680
Investigational Site Number 036011
Investigational Site Number 484032
Investigational Site Number 620007
Investigational Site Number 528003
Investigational Site Number 076021
Investigational Site Number 410002
Investigational Site Number 642022
Investigational Site Number 840066
Investigational Site Number 356018
Investigational Site Number 642016
Investigational Site Number 152003
Investigational Site Number 840678
Investigational Site Number 036005
Investigational Site Number 152004
Investigational Site Number 356019
Investigational Site Number 356013
Investigational Site Number 276005
Investigational Site Number 840198
Investigational Site Number 840322
Investigational Site Number 643005
Investigational Site Number 643036
Investigational Site Number 156028
Investigational Site Number 840044
Investigational Site Number 208001
Investigational Site Number 156015
Investigational Site Number 840312
Investigational Site Number 688001
Investigational Site Number 840481
Investigational Site Number 032018
Investigational Site Number 100007
Investigational Site Number 608002
Investigational Site Number 356017
Investigational Site Number 642018
Investigational Site Number 616013
Investigational Site Number 840550
Investigational Site Number 840286
Investigational Site Number 410014
Investigational Site Number 643029
Investigational Site Number 100010
Investigational Site Number 410004
Investigational Site Number 032006
Investigational Site Number 616008
Investigational Site Number 792008
Investigational Site Number 376012
Investigational Site Number 642033
Investigational Site Number 604009
Investigational Site Number 840388
Investigational Site Number 380020
Investigational Site Number 356026
Investigational Site Number 840459
Investigational Site Number 156004
Investigational Site Number 642010
Investigational Site Number 356010
Investigational Site Number 152008
Investigational Site Number 032047
Investigational Site Number 208004
Investigational Site Number 276017
Investigational Site Number 710019
Investigational Site Number 840677
Investigational Site Number 840047
Investigational Site Number 032002
Investigational Site Number 208002
Investigational Site Number 792014
Investigational Site Number 208010
Investigational Site Number 410007
Investigational Site Number 840581
Investigational Site Number 032024
Investigational Site Number 642002
Investigational Site Number 392025
Investigational Site Number 840028
Investigational Site Number 410009
Investigational Site Number 100006
Investigational Site Number 208005
Investigational Site Number 643013
Investigational Site Number 032004
Investigational Site Number 276016
Investigational Site Number 643037
Investigational Site Number 826045
Investigational Site Number 528006
Investigational Site Number 356027
Investigational Site Number 840414
Investigational Site Number 032037
Investigational Site Number 170020
Investigational Site Number 616012
Investigational Site Number 032045
Investigational Site Number 250001
Investigational Site Number 484003
Investigational Site Number 276009
Investigational Site Number 840628
Investigational Site Number 392001
Investigational Site Number 246005
Investigational Site Number 840608
Investigational Site Number 208011
Investigational Site Number 032011
Investigational Site Number 484021
Investigational Site Number 156009
Investigational Site Number 578002
Investigational Site Number 792013
Investigational Site Number 124001
Investigational Site Number 100005
Investigational Site Number 840328
Investigational Site Number 356004
Investigational Site Number 840152
Investigational Site Number 356022
Investigational Site Number 804011
Investigational Site Number 392018
Investigational Site Number 643027
Investigational Site Number 250007
Investigational Site Number 840385
Investigational Site Number 170004
Investigational Site Number 643059
Investigational Site Number 642020
Investigational Site Number 032051
Investigational Site Number 320002
Investigational Site Number 804008
Investigational Site Number 784001
Investigational Site Number 826036
Investigational Site Number 840381
Investigational Site Number 410010
Investigational Site Number 124027
Investigational Site Number 320015
Investigational Site Number 208007
Investigational Site Number 840232
Investigational Site Number 268003
Investigational Site Number 032035
Investigational Site Number 380011
Investigational Site Number 840353
Investigational Site Number 392022
Investigational Site Number 616014
Investigational Site Number 840250
Investigational Site Number 840656
Investigational Site Number 792001
Investigational Site Number 840046
Investigational Site Number 840545
Investigational Site Number 158007
Investigational Site Number 840422
Investigational Site Number 076025
Investigational Site Number 170012
Investigational Site Number 152028
Investigational Site Number 484020
Investigational Site Number 380004
Investigational Site Number 440001
Investigational Site Number 152014
Investigational Site Number 840592
Investigational Site Number 643040
Investigational Site Number 170022
Investigational Site Number 158002
Investigational Site Number 840504
Investigational Site Number 840261
Investigational Site Number 840096
Investigational Site Number 688010
Investigational Site Number 124024
Investigational Site Number 124005
Investigational Site Number 156023
Investigational Site Number 616011
Investigational Site Number 643039
Investigational Site Number 688008
Investigational Site Number 752002
Investigational Site Number 840565
Investigational Site Number 840624
Investigational Site Number 032005
Investigational Site Number 840654
Investigational Site Number 356016
Investigational Site Number 076001
Investigational Site Number 268002
Investigational Site Number 643043
Investigational Site Number 643060
Investigational Site Number 643038
Investigational Site Number 826008
Investigational Site Number 484025
Investigational Site Number 356032
Investigational Site Number 152022
Investigational Site Number 484005
Investigational Site Number 840275
Investigational Site Number 724020
Investigational Site Number 218001
Investigational Site Number 840268
Investigational Site Number 032028
Investigational Site Number 840290
Investigational Site Number 246003
Investigational Site Number 392011
Investigational Site Number 604006
Investigational Site Number 608005
Investigational Site Number 170010
Investigational Site Number 840240
Investigational Site Number 218002
Investigational Site Number 376001
Investigational Site Number 250014
Investigational Site Number 376005
Investigational Site Number 032039
Investigational Site Number 804013
Investigational Site Number 724016
Investigational Site Number 840454
Investigational Site Number 484024
Investigational Site Number 840210
Investigational Site Number 604011
Investigational Site Number 643042
Investigational Site Number 036001
Investigational Site Number 356006
Investigational Site Number 840696
Investigational Site Number 032066
Investigational Site Number 100004
Investigational Site Number 840404
Investigational Site Number 356024
Investigational Site Number 392020
Investigational Site Number 840575
Investigational Site Number 392017
Investigational Site Number 250012
Investigational Site Number 840310
Investigational Site Number 484011
Investigational Site Number 840199
Investigational Site Number 484034
Investigational Site Number 643016
Investigational Site Number 840623
Investigational Site Number 356015
Investigational Site Number 840576
Investigational Site Number 356023
Investigational Site Number 392002
Investigational Site Number 616028
Investigational Site Number 616024
Investigational Site Number 076016
Investigational Site Number 616001
Investigational Site Number 642011
Investigational Site Number 380009
Investigational Site Number 356030
Investigational Site Number 724004
Investigational Site Number 840360
Investigational Site Number 484014
Investigational Site Number 643061
Investigational Site Number 710020
Investigational Site Number 642001
Investigational Site Number 840513
Investigational Site Number 320012
Investigational Site Number 826023
Investigational Site Number 752006
Investigational Site Number 840503
Investigational Site Number 840326
Investigational Site Number 804012
Investigational Site Number 643035
Investigational Site Number 840692
Investigational Site Number 392010
Investigational Site Number 643018
Investigational Site Number 840455
Investigational Site Number 826007
Investigational Site Number 818001
Investigational Site Number 250005
Investigational Site Number 392021
Investigational Site Number 608006
Investigational Site Number 840534
Investigational Site Number 246007
Investigational Site Number 356031
Investigational Site Number 710006
Investigational Site Number 376004
Investigational Site Number 710011
Investigational Site Number 152036
Investigational Site Number 484033
Investigational Site Number 156034
Investigational Site Number 840251
Investigational Site Number 604002
Investigational Site Number 826034
Investigational Site Number 840509
Investigational Site Number 840706
Investigational Site Number 410011
Investigational Site Number 804005
Investigational Site Number 170024
Investigational Site Number 392007
Investigational Site Number 578001
Investigational Site Number 152029
Investigational Site Number 032046
Investigational Site Number 268001
Investigational Site Number 840196
Investigational Site Number 840350
Investigational Site Number 156033
Investigational Site Number 642014
Investigational Site Number 840008
Investigational Site Number 616023
Investigational Site Number 840346
Investigational Site Number 410001
Investigational Site Number 320014
Investigational Site Number 392012
Investigational Site Number 826018
Investigational Site Number 032052
Investigational Site Number 643006
Investigational Site Number 392004
Investigational Site Number 356002
Investigational Site Number 792003
Investigational Site Number 428006
Investigational Site Number 620001
Investigational Site Number 752009
Investigational Site Number 032030
Investigational Site Number 392003
Investigational Site Number 840043
Investigational Site Number 840241
Investigational Site Number 788005
Investigational Site Number 208003
Investigational Site Number 792007
Investigational Site Number 036016
Investigational Site Number 208008
Investigational Site Number 484018
Investigational Site Number 642015
Investigational Site Number 112002
Investigational Site Number 826037
Investigational Site Number 246009
Investigational Site Number 152002
Investigational Site Number 643047
Investigational Site Number 484023
Investigational Site Number 826038
Investigational Site Number 724017
Investigational Site Number 840520
Investigational Site Number 076018
Investigational Site Number 804009
Investigational Site Number 152023
Investigational Site Number 356021
Investigational Site Number 616020
Investigational Site Number 642034
Investigational Site Number 392015
Investigational Site Number 604017
Investigational Site Number 840023
Investigational Site Number 158003
Investigational Site Number 643012
Investigational Site Number 233006
Investigational Site Number 152034
Investigational Site Number 840180
Investigational Site Number 484013
Investigational Site Number 710005
Investigational Site Number 076008
Investigational Site Number 818002
Investigational Site Number 170002
Investigational Site Number 233003
Investigational Site Number 156020
Investigational Site Number 152001
Investigational Site Number 392016
Investigational Site Number 840285
Investigational Site Number 826026
Investigational Site Number 840128
Investigational Site Number 784002
Investigational Site Number 392008
Investigational Site Number 840168
Investigational Site Number 124002
Investigational Site Number 616029
Investigational Site Number 032015
Investigational Site Number 616022
Investigational Site Number 752007
Investigational Site Number 076004
Investigational Site Number 710017
Investigational Site Number 642026
Investigational Site Number 724003
Investigational Site Number 710001
Investigational Site Number 643011
Investigational Site Number 840072
Investigational Site Number 032063
Investigational Site Number 356009
Investigational Site Number 826002
Investigational Site Number 376011
Investigational Site Number 840676
Investigational Site Number 410013
Investigational Site Number 208006
Investigational Site Number 840206
Investigational Site Number 840019
Investigational Site Number 578003
Investigational Site Number 840466
Investigational Site Number 484001
Investigational Site Number 724008
Investigational Site Number 840446
Investigational Site Number 604019
Investigational Site Number 124025
Investigational Site Number 710010
Investigational Site Number 604005
Investigational Site Number 804010
Investigational Site Number 100016
Investigational Site Number 428004
Investigational Site Number 642003
Investigational Site Number 276018
Investigational Site Number 392005
Investigational Site Number 158001
Investigational Site Number 826016
Investigational Site Number 032062
Investigational Site Number 484028
Investigational Site Number 826010
Investigational Site Number 608001
Investigational Site Number 840464
Investigational Site Number 643062
Investigational Site Number 076010
Investigational Site Number 032033
Investigational Site Number 616019
Investigational Site Number 528004
Investigational Site Number 840344
Investigational Site Number 392014
Investigational Site Number 032038
Investigational Site Number 170013
Investigational Site Number 604001
Investigational Site Number 032042
Investigational Site Number 276028
Investigational Site Number 688009
Investigational Site Number 840671
Investigational Site Number 250008
Investigational Site Number 032056
Investigational Site Number 320008
Investigational Site Number 840477
Investigational Site Number 076006
Investigational Site Number 643004
Investigational Site Number 840529
Investigational Site Number 076026
Investigational Site Number 840689
Investigational Site Number 392023
Investigational Site Number 380024
Investigational Site Number 032003
Investigational Site Number 170019
Investigational Site Number 840447
Investigational Site Number 643014
Investigational Site Number 840368
Investigational Site Number 320007
Investigational Site Number 032008
Investigational Site Number 840465
Investigational Site Number 840427
Investigational Site Number 152042
Investigational Site Number 840657
Investigational Site Number 156014
Investigational Site Number 276007
Investigational Site Number 826017
Investigational Site Number 152013
Investigational Site Number 643051
Investigational Site Number 246012
Investigational Site Number 208009
Investigational Site Number 724018
Investigational Site Number 616025
Investigational Site Number 276026
Investigational Site Number 840445
Investigational Site Number 840637
Investigational Site Number 840524
Investigational Site Number 840530
Investigational Site Number 440005
Investigational Site Number 840400
Investigational Site Number 840667
Investigational Site Number 152025
Investigational Site Number 100011
Investigational Site Number 218005
Investigational Site Number 392009
Investigational Site Number 840345
Investigational Site Number 276025
Investigational Site Number 616021
Investigational Site Number 840663
Investigational Site Number 616006
Investigational Site Number 376002
Investigational Site Number 688002
Investigational Site Number 484004
Investigational Site Number 710007
Investigational Site Number 788004
Investigational Site Number 170007
Investigational Site Number 170005
Investigational Site Number 440004
Investigational Site Number 840532
Investigational Site Number 392024
Investigational Site Number 056003
Investigational Site Number 840589
Investigational Site Number 076007
Investigational Site Number 100001
Investigational Site Number 276014
Investigational Site Number 484035

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

summary:
Primary Objective:

- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.
composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.
urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.


type: Other Identifier

title: Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"

acronym: COMBO-DN

summary: This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Sweden
Switzerland
Mexico
Netherlands
Croatia
France
Greece
Korea, Republic of
Poland
Australia
Spain
Turkey
Germany
United Kingdom
Canada

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.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.

name: Cardiovascular Division Brigham & Women’s Hospital Harvard Medical School Boston MA

name: Faculdade Ciências Médicas de Minas Gerais Fundação Educacional Lucas Machado Belo Horizonte Minas Gerais Brazil

family: Malachias

full_name: Marcus V. B. Malachias

given: Marcus V. B.

sequence: first

name: Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom

family: Jhund

full_name: Pardeep S. Jhund

given: Pardeep S.

sequence: additional

full_name: Brian L. Claggett

given: Brian L.

name: Department of Internal Medicine and Department of Health, Medicine and Caring Sciences Linköping University Norrköping Sweden

name: Massachusetts General Hospital Harvard Medical School Boston MA

family: Bentley‐Lewis

full_name: Rhonda Bentley‐Lewis

given: Rhonda

name: MRC Unit for Lifelong Health and Ageing at UCL Institute for Cardiovascular Sciences University College London London United Kingdom

family: Chaturvedi

full_name: Nishi Chaturvedi

given: Nishi

family: Desai

full_name: Akshay S. Desai

given: Akshay S.

name: Department of Medicine and Clinical Epidemiology University of Texas Health Science Center San Antonio TX

family: Haffner

full_name: Steven M. Haffner

given: Steven M.

name: Department of Medical Endocrinology Rigshospitalet University of Copenhagen Denmark

family: Parving

full_name: Hans‐Henrik Parving

given: Hans‐Henrik

family: Prescott

full_name: Margaret F. Prescott

given: Margaret F.

family: Solomon

name: Department of Clinical Pharmacy and Pharmacology University Medical Center Groningen University of Groningen the Netherlands

family: De Zeeuw

full_name: Dick De Zeeuw

given: Dick

full_name: John J. V. McMurray

given: John J. V.

full_name: Marc A. Pfeffer

given: Marc A.

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license_normalized: no license

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

repository_institution: Linkoping University - DiVA

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

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_institution: The University of Glasgow - Enlighten: Publications

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: NT‐proBNP by Itself Predicts Death and Cardiovascular Events in High‐Risk Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Heerspink HJ, Persson F, Brenner BM, Chaturvedi N, Brunel P, McMurray JJ, Desai AS, Solomon SD, Pfeffer MA, Parving HH, de Zeeuw D. Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi: 10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.

ReferenceCitation: Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

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

title: Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes

ReferenceCitation: Lambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31. doi: 10.1097/HJH.0b013e3283310f92. Review.

location_country:
Peru
Guatemala
Finland
Greece
Belgium
Denmark
Czech Republic
Taiwan
India
France
Japan
Lithuania
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Switzerland
Netherlands
Singapore
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Venezuela
Spain
Turkey

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

summary:
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.


title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

summary: The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

ReferenceCitation: Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

name: Faculty of Pharmacy; The University of Jordan; Amman Jordan

family: Saleh

full_name: Mohammad I Saleh

given: Mohammad I

name: Jordan Royal Medical Services; Amman Jordan

family: Obeidat

full_name: Abdullah R Obeidat

given: Abdullah R

family: Anter

full_name: Hanan A Anter

given: Hanan A

name: Department of Medicine; Division of Haematology and Oncology; The University of Texas Medical Branch; Galveston Texas USA

family: Khanfar

full_name: Anas A Khanfar

given: Anas A

journal_name: Clinical and Experimental Pharmacology and Physiology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gómez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

name: Department of Internal Medicine University of Genoa  Genoa Italy

family: Giannini

full_name: Edoardo G Giannini

given: Edoardo G

name: Division of Gastroenterology Beth Israel Deaconess Medical Center and Harvard Medical School  Boston Massachusetts USA

family: Afdhal

full_name: Nezam H Afdhal

given: Nezam H

name: Department of Medicine New York University School of Medicine  New York New York USA

family: Sigal

full_name: Samuel H Sigal

given: Samuel H

name: Duke Clinical Research Institute, Division of Gastroenterology Duke University Medical Center  Durham North Carolina USA

family: Muir

full_name: Andrew J Muir

given: Andrew J

name: University of Pennsylvania School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA

family: Reddy

full_name: K Rajender Reddy

given: K Rajender

name: Department of Medical Gastroenterology Sri Ramachandra University  Chennai India

family: Vijayaraghavan

full_name: Shanthi Vijayaraghavan

given: Shanthi

name: Department of Hepatology Toronto Liver Center  Toronto Canada

family: Elkashab

full_name: Magdy Elkashab

given: Magdy

name: Unit for Medical and Surgical Management of Digestive Diseases and CIBERehd, Valme University Hospital University of Seville  Sevilla Spain

family: Romero‐Gómez

full_name: Manuel Romero‐Gómez

given: Manuel

name: Centre for Hepatology University College London Medical School  London UK

family: Dusheiko

full_name: Geoffrey M Dusheiko

given: Geoffrey M

name: GlaxoSmithKline  Collegeville Pennsylvania USA

family: Iyengar

full_name: Malini Iyengar

given: Malini

family: Vasey

full_name: Sandra Y Vasey

given: Sandra Y

name: GlaxoSmithKline Stockley Park  Uxbridge UK

family: Campbell

full_name: Fiona M Campbell

given: Fiona M

name: GlaxoSmithKline Research Triangle Park  North Carolina USA

family: Theodore

full_name: Dickens Theodore

given: Dickens

journal_name: Journal of Gastroenterology and Hepatology

oa_colors: green hybrid

evidence: open (via crossref license)

title: Non‐cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy

ReferenceCitation: Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

title: Eltrombopag Increases Platelet Numbers in Thrombocytopenic Patients With HCV Infection and Cirrhosis, Allowing for Effective Antiviral Therapy

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
India
Pakistan
France
Poland
Slovakia
Canada
Korea, Republic of
Puerto Rico
United States
Germany
Italy
Brazil
Israel
Egypt
Spain


title: A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Midazolam for Continuous Sedation of Ventilated Patients in Intensive Care Unit

acronym: MIDEX

summary:
Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Midazolam is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation)

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study, dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam.

in this study we hope to show that: dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable, and that they are able to co-operate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.

ReferenceCitation: Turunen H, Jakob SM, Ruokonen E, Kaukonen KM, Sarapohja T, Apajasalo M, Takala J. Dexmedetomidine versus standard care sedation with propofol or midazolam in intensive care: an economic evaluation. Crit Care. 2015 Feb 19;19:67. doi: 10.1186/s13054-015-0787-y.

family: Turunen

full_name: Heidi Turunen

given: Heidi

family: Jakob

full_name: Stephan M Jakob

given: Stephan M

family: Ruokonen

full_name: Esko Ruokonen

given: Esko

family: Kaukonen

full_name: Kirsi-Maija Kaukonen

given: Kirsi-Maija

family: Sarapohja

full_name: Toni Sarapohja

given: Toni

family: Apajasalo

full_name: Marjo Apajasalo

given: Marjo

family: Takala

full_name: Jukka Takala

given: Jukka

currency_apc_doaj: GBP

journal_name: Critical Care

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repositories_institution: University Library Bern - BORIS - Bern Open Repository and Information System

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.

full_name: Stephan M. Jakob

given: Stephan M.

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Dexmedetomidine vs Midazolam or Propofol for Sedation During Prolonged Mechanical Ventilation

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Switzerland
Netherlands
Finland
France
Norway
Belgium
Estonia
Germany
United Kingdom

location_facility: Universitatsklinikum Bonn, Klinik u. Poliklinik f. Anasthesiologie u. Operative Intensivmedizin, Sigmund-Freud-Strasse 25

location_facility: Centre Hospitalier Victor Dupouy Hopital Dupuytren, Service Reanimation Polyvalente, 69, Rue du Lt Colonel Prud'hon

location_facility: North Estonian Regional Hospital, Dept. of Postoperative Intensive Care, J. Sutiste Tee 18

location_facility: Centre Hospitalier Universitaire d'Angers, Reanimation medicale est de Mededicne Hyperbare, 4 Rue Larrey

location_facility: University Hospital Birmingham, Department of Anaesthesia, Queen Elizabeth Hospital,

location_facility: CHU de Liege (Sart Tilman), Domaine de Sart-Tilman

location_facility: Rikshospitalet, Universitetsklinikk, Sognsvannsveien 20

location_facility: Aker Universtetssykehus HF, Anestesiavdelingen, Trondheimsveien 235

location_facility: Universitatsspital Zurich, Klinik fur Innere Medizin, Intensivstation, Ramistrasse 100

location_facility: Viecuri MC voor Noord-Limburg, Locatie Venlo, Dept. Intensieve Zorgen, Tegelseweg 210

location_facility: Derriford Hospital, Dept. of Intensive Care Level 4, Derriford Road

location_facility: Centre Hospitalier Universitaire Limoges Hopital Dupuytren, Service de Reanimation Polyvalente, 2, Avenue Martin Luther King

location_facility: Haukeland University Hospital, Intensive Care Unit, Jonas Liesvei 65

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul, Service de Reanimation Medicale, 27 Rue du Faubourg Saint Jacques

location_facility: Centre Hospitalier La Roche sur Yon CHD les Oudaireis, Service Reanimation CHD la Roche sur Yon, Les Oudairies

location_facility: Centre Hospitalier Universitaire de Grenoble, Service de Reanimation Medicale, Boulevard de la Chantourne, BP 217

location_facility: Ulleval University Hospital, Medical and Surgical ICU, Kirkeveien 166

location_facility: Hopital Foch, Service Renimation, 40 Rue Worth, Suresnes Hauts de Seine

location_facility: North Estonian Regional Hospital, Centre of Intensive Care, J. Sutiste Tee 18

location_facility: Universitatsklinikum Greifswald, Klinik u. Poliklinik f. Anasthesiologie u. Intensivmedizin, Friedrich-Loeffler-Str. 23b

location_facility: Hopital Albert Calmette, Boulevard Du Pr. Jules Leclercq

location_facility: Centre Hospitalier Universitaire de Poitiers, Reanimation Medicale, 2, Rue de la Miletrie

location_facility: Amphia Ziekenhuis, Dept. Intensieve Zorgen, Molengracht 21

location_facility: Isala Klinieken, Locatie Weezenlanden, Groot Wezenland 20

location_facility: Universitatsklinikum Tubingen, Klinik fur Anasthesiologie und Intensivmedizin, Hoppe-Seyler-Strasse 3

location_facility: Gelre Hospitals - Locatie Lucas, A.Schweitzerlaan 32

location_facility: Centre Hospitalier Universitaire d'Orleans, Reanimation Medicale, 1, rue Prote Madeleine, BP 2439

location_facility: Kantonsspital Winterthur, Brauerstrasse 15,

location_facility: Birmingham Heartlands Hospital, Bordesely Green East

location_facility: Saint Elisabeth Ziekenhuis, Dept. Intensieve Zorgen, Hilvarenbeekseweg 60

location_facility: Centre Hospitalier Regional et Universitaire - Hopital Bretonneau Service Reanimation Medicale Polyvalente, 2, Boulevard Tonnelle, Tours cedex 9

location_facility: Tartu University Hospistal, Clinic of Anesthesiology and Intensive Care, L. Puusepa 8

location_facility: Oulu University Hospital, Kajaanintie 50

location_facility: UZ Brussel, Intensive Care Dept. Laarbeeklaan 101

location_facility: Universitaer Ziekenhuis Gent, Intensieve Zorgen, De Pintelaan 185

location_facility: Hopital Bichat-Claude, Dept. D'Anasehesie et Reanimation Chirurgicale, 46, rue Henri-Huchard

location_facility: East Tallinn Central Hospital, Ravi Stret 18

location_facility: Albert Schweitzer Hospital, Locatie Dordwikj, Albert Schweitzerplaats 25


title: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications

summary: No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

family: Grimm

full_name: Michael Grimm

given: Michael

family: Han

full_name: Jenny Han

given: Jenny

family: Weaver

full_name: Carole Weaver

given: Carole

family: Griffin

full_name: Pete Griffin

given: Pete

family: Schulteis

full_name: Christine T. Schulteis

given: Christine T.

family: Dong

full_name: Haiying Dong

given: Haiying

family: Malloy

full_name: Jaret Malloy

given: Jaret

journal_name: Postgraduate Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Efficacy, Safety, and Tolerability of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus: An Integrated Analysis of the DURATION Trials

ReferenceCitation: Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7.

family: Buse

full_name: John B Buse

given: John B

family: Nauck

full_name: Michael Nauck

family: Forst

full_name: Thomas Forst

given: Thomas

family: Sheu

full_name: Wayne H-H Sheu

given: Wayne H-H

family: Shenouda

full_name: Sylvia K Shenouda

given: Sylvia K

family: Heilmann

full_name: Cory R Heilmann

given: Cory R

family: Hoogwerf

full_name: Byron J Hoogwerf

given: Byron J

family: Gao

full_name: Aijun Gao

given: Aijun

family: Boardman

full_name: Marilyn K Boardman

given: Marilyn K

family: Fineman

full_name: Mark Fineman

given: Mark

family: Porter

full_name: Lisa Porter

given: Lisa

family: Schernthaner

full_name: Guntram Schernthaner

given: Guntram

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

location_country:
Greece
Romania
Australia
Belgium
Czech Republic
Taiwan
India
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Hungary
Germany
Italy
Austria
Mexico
Israel
Spain


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. Epub 2016 Sep 27. Review.

ReferenceCitation: San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Günther 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.

family: San-Miguel

full_name: Jesús F San-Miguel

given: Jesús F

family: Hungria

full_name: Vania T M Hungria

given: Vania T M

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

family: Beksac

full_name: Meral Beksac

given: Meral

family: Dimopoulos

full_name: Meletios A Dimopoulos

given: Meletios A

family: Elghandour

full_name: Ashraf Elghandour

given: Ashraf

family: Jedrzejczak

full_name: Wieslaw W Jedrzejczak

given: Wieslaw W

family: Günther

full_name: Andreas Günther

given: Andreas

family: Nakorn

full_name: Thanyaphong N Nakorn

given: Thanyaphong N

family: Siritanaratkul

full_name: Noppadol Siritanaratkul

given: Noppadol

family: Schlossman

full_name: Robert L Schlossman

given: Robert L

family: Hou

full_name: Jian Hou

given: Jian

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Lonial

full_name: Sagar Lonial

given: Sagar

family: Lee

full_name: Jae H Lee

given: Jae H

family: Einsele

full_name: Hermann Einsele

given: Hermann

family: Sopala

full_name: Monika Sopala

given: Monika

family: Bengoudifa

full_name: Bourras-Rezki Bengoudifa

given: Bourras-Rezki

family: Binlich

full_name: Florence Binlich

given: Florence

family: Richardson

full_name: Paul G Richardson

given: Paul G

journal_name: The Lancet Haematology

publisher_group: Elsevier

publisher_normalized: Elsevier

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.

name: Dana-Farber Cancer Institute, Boston, MA;

full_name: Paul G. Richardson

given: Paul G.

name: Irmandade da Santa Casa de Misericordia de São Paulo, São Paulo, Brazil;

full_name: Vânia T. M. Hungria

given: Vânia T. M.

name: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;

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

name: National and Kapodistrian University of Athens, Athens, Greece;

name: Alexandria University, Alexandria, Egypt;

name: Medical University of Warsaw, Warsaw, Poland;

name: Division of Stem Cell Transplantation and Immunotherapy, 2nd Department of Medicine, University Hospital Schleswig-Holstein and University of Kiel, Kiel, Germany;

name: King Chulalongkorn Memorial Hospital and Chulalongkorn University, Bangkok, Thailand;

name: University Hospital of Nantes, Nantes, France;

name: Winship Cancer Institute, Emory University, Atlanta, GA;

name: Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Republic of Korea;

name: Medizinische Klinik und Poliklinik II, University of Würzburg, Würzburg, Germany;

name: Novartis Pharma SAS, Rueil-Malmaison, France; and

name: Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain

ReferenceCitation: San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Günther 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, Bladé 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.

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

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

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.


lead_sponsor: Boehringer Ingelheim

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

location_facility: 1245.33.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01054 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01031 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01011 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01019 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01015 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01047 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44009 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01058 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01035 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01038 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01046 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01023 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01062 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44010 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01017 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01044 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01051 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01056 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01016 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01061 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01042 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01055 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01045 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35106 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3308A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35101 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01025 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01022 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01041 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01029 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01033 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01040 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01036 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35102 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01059 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01014 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01012 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01013 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01032 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35107 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01010 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35302 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01024 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01020 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45011 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01027 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35104 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45013 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01050 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01043 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01037 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01018 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01028 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01030 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01026 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35303 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35304 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01049 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01060 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01009 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01048 Boehringer Ingelheim Investigational Site

type: EudraCT Number

source: euctr

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

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.


title: Safety and Antiviral Activity of TPV in Hepatitis C or Hepatitis B HIV Coinfected Patients - TDM Randomised Pilot Evaluation

summary: The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

status: Terminated

location_country:
Italy
Brazil
Germany
France
Argentina
Spain
United States

location_facility: 1182.99.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310D Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310H Boehringer Ingelheim Investigational Site

location_facility: 1182.99.4 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310F Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310E Boehringer Ingelheim Investigational Site

location_facility: 1182.99.12 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3306G Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310C Boehringer Ingelheim Investigational Site

location_facility: 1182.99.31 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3304A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.32 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55004 Unidade de Referência em doenças Infecciosas Preveníveis

location_facility: 1182.99.3906 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310G Boehringer Ingelheim Investigational Site

location_facility: 1182.99.1 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3302A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3306K Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55001 Universidade Federal de Sao Paulo

location_facility: 1182.99.4909 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55003 Centro de Referência e Treinamento - DST/AIDS

location_facility: 1182.99.3911 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3304C Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3301A Boehringer Ingelheim Investigational Site

status_simplified: Unknown


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.

family: Kolamunnage-Dona

full_name: Ruwanthi Kolamunnage-Dona

given: Ruwanthi

family: Berhane

full_name: Sarah Berhane

given: Sarah

family: Potts

full_name: Harry Potts

given: Harry

family: Williams

full_name: Edward H. Williams

given: Edward H.

family: Tanner

full_name: James Tanner

given: James

family: Janowitz

full_name: Tobias Janowitz

given: Tobias

family: Hoare

full_name: Matthew Hoare

given: Matthew

family: Johnson

full_name: Philip Johnson

given: Philip

journal_name: Journal of Hepatology

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.

name: Calin Cainap, University of Medicine and Pharmacy Cluj Napoca, Cluj-Napoca, Romania; Shukui Qin, Chinese People's Liberation Army Cancer Center, Bayi Hospital, Beijing; Hongming Pan, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou; Ying Cheng, Tumor Hospital of Jilin Province, Changchun, People's Republic of China; Wen-Tsung Huang, Chi Mei Medical Center, Liouying; Pei-Jer Chen, National Taiwan University Hospital, Taipei, Taiwan, Republic of China; Ik Joo Chung, Chonnam National University,...

family: Cainap

full_name: Calin Cainap

given: Calin

family: Qin

full_name: Shukui Qin

given: Shukui

family: Huang

full_name: Wen-Tsung Huang

given: Wen-Tsung

family: Chung

full_name: Ik Joo Chung

given: Ik Joo

family: Pan

full_name: Hongming Pan

given: Hongming

family: Cheng

full_name: Ying Cheng

given: Ying

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Chen

full_name: Pei-Jer Chen

given: Pei-Jer

family: Toh

full_name: Han-Chong Toh

given: Han-Chong

family: Gorbunova

full_name: Vera Gorbunova

given: Vera

family: Eskens

full_name: Ferry A.L.M. Eskens

given: Ferry A.L.M.

family: Qian

full_name: Jiang Qian

given: Jiang

family: McKee

full_name: Mark D. McKee

given: Mark D.

family: Ricker

repositories_institution:
Erasmus University, Rotterdam - RePub
PubMed Central - Europe PMC

publisher: American Society of Clinical Oncology (ASCO)

title: Linifanib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma: Results of a Randomized Phase III Trial

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

location_facility:
Site Reference ID/Investigator# 40624
Site Reference ID/Investigator# 43442
Site Reference ID/Investigator# 33343
Site Reference ID/Investigator# 23457
Site Reference ID/Investigator# 23468
Site Reference ID/Investigator# 24848
Site Reference ID/Investigator# 23184
Site Reference ID/Investigator# 23459
Site Reference ID/Investigator# 43302
Site Reference ID/Investigator# 27998
Site Reference ID/Investigator# 27122
Site Reference ID/Investigator# 23471
Site Reference ID/Investigator# 43203
Site Reference ID/Investigator# 23186
Site Reference ID/Investigator# 36308
Site Reference ID/Investigator# 23608
Site Reference ID/Investigator# 23200
Site Reference ID/Investigator# 27343
Site Reference ID/Investigator# 23165
Site Reference ID/Investigator# 23845
Site Reference ID/Investigator# 24980
Site Reference ID/Investigator# 23461
Site Reference ID/Investigator# 23189
Site Reference ID/Investigator# 29758
Site Reference ID/Investigator# 36964
Site Reference ID/Investigator# 29759
Site Reference ID/Investigator# 23254
Site Reference ID/Investigator# 28187
Site Reference ID/Investigator# 23450
Site Reference ID/Investigator# 26507
Site Reference ID/Investigator# 23270
Site Reference ID/Investigator# 23153
Site Reference ID/Investigator# 39002
Site Reference ID/Investigator# 33346
Site Reference ID/Investigator# 26506
Site Reference ID/Investigator# 43237
Site Reference ID/Investigator# 23603
Site Reference ID/Investigator# 23478
Site Reference ID/Investigator# 23454
Site Reference ID/Investigator# 23463
Site Reference ID/Investigator# 26503
Site Reference ID/Investigator# 23447
Site Reference ID/Investigator# 23849
Site Reference ID/Investigator# 26505
Site Reference ID/Investigator# 27959
Site Reference ID/Investigator# 36782
Site Reference ID/Investigator# 27969
Site Reference ID/Investigator# 44443
Site Reference ID/Investigator# 25262
Site Reference ID/Investigator# 23462
Site Reference ID/Investigator# 23473
Site Reference ID/Investigator# 26509
Site Reference ID/Investigator# 23267
Site Reference ID/Investigator# 23250
Site Reference ID/Investigator# 27968
Site Reference ID/Investigator# 23194
Site Reference ID/Investigator# 23158
Site Reference ID/Investigator# 23852
Site Reference ID/Investigator# 29757
Site Reference ID/Investigator# 23160
Site Reference ID/Investigator# 43443
Site Reference ID/Investigator# 23252
Site Reference ID/Investigator# 24523
Site Reference ID/Investigator# 39614
Site Reference ID/Investigator# 43144
Site Reference ID/Investigator# 23469
Site Reference ID/Investigator# 24042
Site Reference ID/Investigator# 23152
Site Reference ID/Investigator# 23166
Site Reference ID/Investigator# 44063
Site Reference ID/Investigator# 23475
Site Reference ID/Investigator# 24782
Site Reference ID/Investigator# 23190
Site Reference ID/Investigator# 37603
Site Reference ID/Investigator# 23428
Site Reference ID/Investigator# 43145
Site Reference ID/Investigator# 25562
Site Reference ID/Investigator# 26063
Site Reference ID/Investigator# 35702
Site Reference ID/Investigator# 23844
Site Reference ID/Investigator# 23842
Site Reference ID/Investigator# 28345
Site Reference ID/Investigator# 33979
Site Reference ID/Investigator# 39003
Site Reference ID/Investigator# 43102
Site Reference ID/Investigator# 40931
Site Reference ID/Investigator# 23266
Site Reference ID/Investigator# 23198
Site Reference ID/Investigator# 23253
Site Reference ID/Investigator# 26504
Site Reference ID/Investigator# 23183
Site Reference ID/Investigator# 23244
Site Reference ID/Investigator# 23269
Site Reference ID/Investigator# 38902
Site Reference ID/Investigator# 23272
Site Reference ID/Investigator# 42705
Site Reference ID/Investigator# 23472
Site Reference ID/Investigator# 23445
Site Reference ID/Investigator# 23150
Site Reference ID/Investigator# 27242
Site Reference ID/Investigator# 23155
Site Reference ID/Investigator# 23197
Site Reference ID/Investigator# 43482
Site Reference ID/Investigator# 23167
Site Reference ID/Investigator# 40162
Site Reference ID/Investigator# 23444
Site Reference ID/Investigator# 33344
Site Reference ID/Investigator# 23191
Site Reference ID/Investigator# 24525
Site Reference ID/Investigator# 33345
Site Reference ID/Investigator# 23470
Site Reference ID/Investigator# 23247
Site Reference ID/Investigator# 23424
Site Reference ID/Investigator# 23162
Site Reference ID/Investigator# 28347
Site Reference ID/Investigator# 42706
Site Reference ID/Investigator# 41542
Site Reference ID/Investigator# 40930
Site Reference ID/Investigator# 35705
Site Reference ID/Investigator# 36967
Site Reference ID/Investigator# 27970
Site Reference ID/Investigator# 23163
Site Reference ID/Investigator# 23268
Site Reference ID/Investigator# 23442
Site Reference ID/Investigator# 23257
Site Reference ID/Investigator# 26508
Site Reference ID/Investigator# 44062
Site Reference ID/Investigator# 28189
Site Reference ID/Investigator# 23161
Site Reference ID/Investigator# 40448
Site Reference ID/Investigator# 23466
Site Reference ID/Investigator# 23846
Site Reference ID/Investigator# 23460
Site Reference ID/Investigator# 44444
Site Reference ID/Investigator# 23425
Site Reference ID/Investigator# 23449
Site Reference ID/Investigator# 23465
Site Reference ID/Investigator# 23168
Site Reference ID/Investigator# 23467
Site Reference ID/Investigator# 24522
Site Reference ID/Investigator# 24103
Site Reference ID/Investigator# 43202
Site Reference ID/Investigator# 40623
Site Reference ID/Investigator# 27967
Site Reference ID/Investigator# 23159
Site Reference ID/Investigator# 23474
Site Reference ID/Investigator# 26702
Site Reference ID/Investigator# 37602
Site Reference ID/Investigator# 23199
Site Reference ID/Investigator# 42563
Site Reference ID/Investigator# 23843
Site Reference ID/Investigator# 42817
Site Reference ID/Investigator# 23456
Site Reference ID/Investigator# 25482
Site Reference ID/Investigator# 23201
Site Reference ID/Investigator# 33977
Site Reference ID/Investigator# 26543
Site Reference ID/Investigator# 43444
Site Reference ID/Investigator# 23477
Site Reference ID/Investigator# 23609
Site Reference ID/Investigator# 23476
Site Reference ID/Investigator# 41488
Site Reference ID/Investigator# 29756

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)

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.


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.

study_start_date_type: Actual

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

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

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

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

location_facility: Thomas Jefferson University Hospital Onc Dept


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.

family: Bajaj

full_name: M. Bajaj

given: M.

name: Safe Harbor Clinical Research East Providence RI USA

family: Gilman

full_name: R. Gilman

given: R.

family: Patel

full_name: S. Patel

given: S.

name: Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield CT USA

family: Kempthorne‐Rawson

full_name: J. Kempthorne‐Rawson

given: J.

family: Lewis‐D'Agostino

full_name: D. Lewis‐D'Agostino

given: D.

name: Boehringer Ingelheim GmbH and Co. KG Ingelheim Germany

family: Woerle

full_name: H.‐J. Woerle

journal_name: Diabetic Medicine

title: 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

location_country:
Philippines
United States
India
France

location_facility: 1218.61.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01028 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01053 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01020 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91005 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63002 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01031 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01044 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01040 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01017 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01007 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01001 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3312A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01030 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3310A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01014 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01046 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01024 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3309A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01018 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3311A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01005 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01023 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01043 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.63004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.3313A Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01008 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01052 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01006 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01015 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01009 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01049 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01042 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01004 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01027 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01016 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.61.01048 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

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.