title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury

acronym: SyNAPSe

summary: The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

ReferenceCitation: Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007 Apr;49(4):391-402, 402.e1-2. doi: 10.1016/j.annemergmed.2006.07.932. Epub 2006 Sep 29.

ReferenceCitation: Xiao G, Wei J, Yan W, Wang W, Lu Z. Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Crit Care. 2008;12(2):R61. doi: 10.1186/cc6887. Epub 2008 Apr 30.

ReferenceCitation: Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, Nelson NR, Stocchetti N; SYNAPSE Trial Investigators. A clinical trial of progesterone for severe traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2467-76. doi: 10.1056/NEJMoa1411090. Epub 2014 Dec 10.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Tampere University - Tampere University Institutional Repository

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: BHR Pharma, LLC

collaborators:
PRA Health Sciences
Syneos Health

sponsor_collaborators:
BHR Pharma, LLC
PRA Health Sciences
Syneos Health

location_country:
Finland
Germany
Argentina
Thailand
France
Czech Republic
Hungary
United States
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Austria
Spain
Taiwan
Russian Federation
Israel

location_facility: Hospital Universitari i Politecnic La Fé de Valencia

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

location_facility: Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika

location_facility: Faculty of Medicine, Prince of Songkla University

location_facility: Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Centre Hospitalier Universitaire de Grenoble- Hópital Michallon

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: The 2nd Affiliated Hospital of Zhejiang University

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: University of California San Diego Medical Center

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: The Second Hospital of Shandong University

location_facility: Hospital Universitario de Girona Dr. Josep Trueta

location_facility: Hospital Nacional "Profesor Alejandro Posadas"

location_facility: Ziekenhuis Oost-Limburg, Location Sint Jan

location_facility: Texas Tech University Health Sciences Center

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Hospital Regional De Comodoro Rivadavia (HRCR)

location_facility: Wake Forest University-Baptist Medical Center

location_facility: Marshall University Joan C. Edwards School of Medicine

location_facility: Azienda Ospedaliero Universitaria Maggiore della Caritá

location_facility: State Institution "Burdenko Neurosurgical Institute of RAMS"

location_facility: Hospital Clínico Universitario De Valencia

location_facility: University Hospital of the Free University Brussels (UZ Brussel)

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Azienda Ospedaliero Universitaria Integrata di Verona

location_facility: Hospital General Universitario de Alicante

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ

location_facility: University of South Alabama Medical Center

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"

location_facility: Fakultní nemocnice Brno Neurochirurgická klinika

location_facility: University of Massachusetts Memorial Medical Center

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development"

location_facility: Leeds Teaching Hospitals NHS, Leeds General Infirmary

location_facility: State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"

location_facility: State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"

location_facility: Universitätsklinikum Gießen und Marburg gGmbH

location_facility: General Hospital of Tianjin Medical University

location_facility: University of Iowa Hospitals and Clinics

location_facility: Saint Petersburg Healthcare Institution "City Mariinsky Hospital"

location_facility: University of South Carolina School of Medicine

location_facility: Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital de Emergencias Clemente Alvarez (HECA)


type: Other Identifier

title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by

license_normalized: cc-by

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;dash.harvard.edu

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

ReferenceCitation: Schernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: The Endocrine Society

ReferenceCitation: Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

oa_host_type: repository

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

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

unpaywall_oa_status: green

ReferenceCitation: Bailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.

publisher_dissemination: Elsevier

ReferenceCitation: Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.

evidence: open (via page says license)

publisher_dissemination: Springer

ReferenceCitation: Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi M, Canovatchel W, Meininger G. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013 Sep;36(9):2508-15. doi: 10.2337/dc12-2491. Epub 2013 Apr 5. Erratum In: Diabetes Care. 2013 Dec;36(12):4172.

location_country:
Germany
Poland
India
New Zealand
Israel
Singapore
Denmark
Brazil
Netherlands
Austria
Belgium
United States
Korea, Republic of
Malaysia
Canada
Ukraine
France


intervention_type: Drug

lead_sponsor: Boehringer Ingelheim

summary:
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.

The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.

A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.

Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

ReferenceCitation: Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Bocher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Bocher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - @rchiveSIC

evidence: oa repository (semantic scholar lookup)

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Bocher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.

evidence: open (via free article)

version: acceptedVersion

ReferenceCitation: Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Bocher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.

publisher_dissemination: SAGE Publications

location_facility: 1241.21.41001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0011 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.40003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.61001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.64001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35105 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.40002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.41003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.43002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0007 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0008 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.61002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.43003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0013 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.40001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35102 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0010 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0017 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.43001 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0019 Boehringer Ingelheim Investigational Site

location_facility: 1241.21.0012 Boehringer Ingelheim Investigational Site

title: Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)

type: EudraCT Number

source: euctr

location_country:
Germany
Portugal
New Zealand
Romania
Australia
Switzerland
Austria
United States
Spain
France


title: A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder

summary: The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

study_start_date_type: Actual

ReferenceCitation: Newcorn JH, Harpin V, Huss M, Lyne A, Sikirica V, Johnson M, Ramos-Quiroga JA, van Stralen J, Dutray B, Sreckovic S, Bloomfield R, Robertson B. Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study. J Child Psychol Psychiatry. 2016 Jun;57(6):717-28. doi: 10.1111/jcpp.12492. Epub 2016 Feb 12.

oa_host_type: publisher

publisher_dissemination: Wiley

lead_sponsor: Shire

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire d'Amiens, Hôpital Nord

location_facility: Centre Hospitalier Universitaire Bocage-Hôpital d'enfants

location_facility: Hopital Robert Debre Centre pediatrique des pathologies du sommeil

location_facility: Center for Psychiatry and Behavioral Medicine, Inc.

location_facility: Praxis Dr. med. Dipl. Psych. Anton Lindermüller

location_facility: Centre de référence Neuropédiatrique Multidisciplinaire

location_facility: Ziekenhuis Inkendaal Koninklijke Instelling v.z.w.

location_facility: Azienda Osp. Fatebenefratelli - Polo Territoriale UONPIA

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Hopital Gatien de Clocheville CHU de Tours

location_facility: JPM van Stralen Medicine Professional Corporation

location_facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)

location_facility: Hospital Son Llàtzer, Laboratorio de Neurociencias IUNICS

location_facility: Sozialpsychiatrisches Centrum Dr. med. Ralph Meyers

location_facility: Norfolk Community Health and Care NHS Trust

location_facility: Psychiatric Centers at San Diego, Feighner Research

location_facility: Klinikum der Johannes-Gutenberg-Universität Mainz

location_facility: Children's and Women's Health Centre of British Columbia

location_facility: Hopitaux Pediatriques de Nice - CHI Lenval

location_facility: Centenary House Child and Adolescent Mental Health Services

location_facility: Encompass Clinical Research - North Coast

location_facility: Mondriaan Zorggroep Heerlen, Kinder en Jeugdp sychiatrie

location_facility: Instituto Valenciano de Neurología Pediatrica

lead_sponsor_type: industriel

status_simplified: Completed


acronym: BEGIN™

lead_sponsor: Novo Nordisk A/S

summary: This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

ReferenceType: result

ReferenceCitation: Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.

title: A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

location_country:
Hungary
Romania
Netherlands
United States
Bulgaria
Canada
France


acronym: COUPLE

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

summary: The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.

ReferenceCitation: McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, Sharma O, Rivas DA, Aquilina JW. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013 Sep;10(9):2312-25. doi: 10.1111/jsm.12236. Epub 2013 Jul 11.

publisher_dissemination: Oxford University Press

title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor

location_country:
Poland
United Kingdom
Argentina
Australia
Mexico
Belgium
United States
Korea, Republic of
Malaysia
Taiwan
Canada
Russian Federation
France


title: A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer

summary: This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.

ReferenceCitation: Van Cutsem E, Bang YJ, Feng-Yi F, Xu JM, Lee KW, Jiao SC, Chong JL, Lopez-Sanchez RI, Price T, Gladkov O, Stoss O, Hill J, Ng V, Lehle M, Thomas M, Kiermaier A, Ruschoff J. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015 Jul;18(3):476-84. doi: 10.1007/s10120-014-0402-y. Epub 2014 Jul 20.

ReferenceCitation: Satoh T, Bang YJ, Gotovkin EA, Hamamoto Y, Kang YK, Moiseyenko VM, Ohtsu A, Van Cutsem E, Al-Sakaff N, Urspruch A, Hill J, Weber HA, Chung HC; ToGA Trial Investigators. Quality of life in the trastuzumab for gastric cancer trial. Oncologist. 2014 Jul;19(7):712-9. doi: 10.1634/theoncologist.2014-0058. Epub 2014 Jun 20.

ReferenceCitation: Satoh T, Omuro Y, Sasaki Y, Hamamoto Y, Boku N, Tamura T, Ohtsu A. Pharmacokinetic analysis of capecitabine and cisplatin in combination with trastuzumab in Japanese patients with advanced HER2-positive gastric cancer. Cancer Chemother Pharmacol. 2012 Apr;69(4):949-55. doi: 10.1007/s00280-011-1783-9. Epub 2011 Nov 25.

ReferenceCitation: Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_country:
Finland
Germany
Australia
Costa Rica
Brazil
Japan
Turkey
France
Portugal
Denmark
India
Belgium
China
Peru
Italy
Guatemala
United Kingdom
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Russian Federation


title: An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder

acronym: AGATE

summary:
Primary Objective:

To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Objectives:

To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
To evaluate plasma concentrations of SSR125543

enrollment_type: Anticipated

lead_sponsor: Sanofi

location_country:
Finland
Germany
Slovakia
Sweden
Netherlands
Belgium
South Africa
Chile
Canada
Estonia
Russian Federation
France

location_facility: Sanofi-Aventis Investigational Site Number 124012

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 246003

location_facility: Sanofi-Aventis Investigational Site Number 124009

location_facility: Sanofi-Aventis Investigational Site Number 152005

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 152006

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 124004

location_facility: Sanofi-Aventis Investigational Site Number 233003

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 152008

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 752003

location_facility: Sanofi-Aventis Investigational Site Number 703104

location_facility: Sanofi-Aventis Investigational Site Number 246002

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 752004

location_facility: Sanofi-Aventis Investigational Site Number 703103

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 752005

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 246004

location_facility: Sanofi-Aventis Investigational Site Number 152007

location_facility: Sanofi-Aventis Investigational Site Number 276008

location_facility: Sanofi-Aventis Investigational Site Number 643005

location_facility: Sanofi-Aventis Investigational Site Number 703101

location_facility: Sanofi-Aventis Investigational Site Number 703105

location_facility: Sanofi-Aventis Investigational Site Number 124011

location_facility: Sanofi-Aventis Investigational Site Number 233001

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 643008

location_facility: Sanofi-Aventis Investigational Site Number 152004

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 246005

location_facility: Sanofi-Aventis Investigational Site Number 643011

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 703102

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 643010

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 643009

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 710004

location_facility: Sanofi-Aventis Investigational Site Number 276005

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 276007

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 710002

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 233004

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 246001

location_facility: Sanofi-Aventis Investigational Site Number 276006

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 124008

location_facility: Sanofi-Aventis Investigational Site Number 152003

location_facility: Sanofi-Aventis Investigational Site Number 276003


acronym: FREEDOM-EXT

lead_sponsor: United Therapeutics

summary: This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Peking Union Medical College Hospital, Respiratory Medicine Department

location_facility: Vancouver Coastal Health Authority Vancouver General Hospital

location_facility: University of California, San Francisco-Fresno

location_facility: Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Pulmonary Institute Chaim Sheba Medical Center

location_facility: Universitaetsklinik für Innere Medizin Innsbruck

location_facility: Department of Cardiology Erasme University Hospital

location_facility: Dept. of Internal Medicine III University Heidelberg

location_facility: University of Minnesota Medical Center, Fairview

location_facility: London Health Sciences Center Victoria Hospital

location_facility: Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche

location_facility: University of Florida College of Medicine Jacksonville

location_facility: The Carl and Ethyl Linder Center for Research and Education at the Christ Church

location_facility: University of California San Francisco Medical Center

location_facility: Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.

location_facility: Heart/Lung Transplant Unit - St. Vincent's Hospital

location_facility: University of Colorado Health Science Center

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Stanford University, Pulmonary and Critical Care Medicine

location_facility: Universitätsklinikum Dresden Abtl. Pneumologie

location_facility: Servico de Cardiologia Hospital de Santa Marta

location_facility: Shanghai Pulmonary Hospital, Respiratory Medicine Department

location_facility: Hadassah Hebrew University Medical Center

location_facility: Pulmonary Hypertension Unit Centre for Lung Health Mater Misericordiae University Hospital

location_facility: University of Arizona Clinical and Translational Science (CATS) Research Center

location_facility: Radboud University Nijmegen Medical Center

location_facility: Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Washington University School of Medicine

location_facility: Beijing Shijitan Hospital, Cadres Respiratory Department

location_facility: Centre d'Investigation Clinique Hôpital La Cavale Blanche - CHU Brest

location_facility: Policlinico S. Orsola Malpighi - Università degli studi di Bologna

location_facility: Universitätsklinkium Köln Klinik III für Innere Medizin

location_facility: Sri Ramachandra Medical College & Research Institute

location_facility: Unidad de Investigacion Clinica en Medicina S.C.

location_facility: Auxilio Mutuo Hospital CardioPulmonary Research Center

location_facility: Service Chirurgie Thoracique, Hôpital Haut Levêque

location_facility: Pulmonary Institute Rabin Medical Center (Belinson Kampus)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Life Care Institute of Medical Sciences & Research

location_facility: Hospital of the University of Pennsylvania

location_facility: Service de Pneumologie Centre de Competence pour l'HTAP- Pole des Voies Respiratoires Hôpital Larrey

location_facility: Asian Heart Institute & Research Centre Pvt. Ltd.

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: CHU Arnaud de Villeneuve - Service maladies respiratoires

title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

location_country:
Germany
Ireland
Poland
Australia
Canada
France
Portugal
United States
India
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Israel

ipd_sharing: No


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

ReferenceCitation: van Rhee F, Rosenthal A, Kanhai K, Martin R, Nishimura K, Hoering A, Fajgenbaum DC. Siltuximab is associated with improved progression-free survival in idiopathic multicentric Castleman disease. Blood Adv. 2022 Aug 23;6(16):4773-4781. doi: 10.1182/bloodadvances.2022007112.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Society of Hematology

ReferenceCitation: Fajgenbaum DC, Uldrick TS, Bagg A, Frank D, Wu D, Srkalovic G, Simpson D, Liu AY, Menke D, Chandrakasan S, Lechowicz MJ, Wong RS, Pierson S, Paessler M, Rossi JF, Ide M, Ruth J, Croglio M, Suarez A, Krymskaya V, Chadburn A, Colleoni G, Nasta S, Jayanthan R, Nabel CS, Casper C, Dispenzieri A, Fossa A, Kelleher D, Kurzrock R, Voorhees P, Dogan A, Yoshizaki K, van Rhee F, Oksenhendler E, Jaffe ES, Elenitoba-Johnson KS, Lim MS. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. Blood. 2017 Mar 23;129(12):1646-1657. doi: 10.1182/blood-2016-10-746933. Epub 2017 Jan 13.

ReferenceCitation: van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fossa A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. doi: 10.1016/S1470-2045(14)70319-5. Epub 2014 Jul 17. Erratum In: Lancet Oncol. 2014 Sep;15(10):417.

title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease

location_country:
Germany
New Zealand
Australia
Brazil
Canada
France
Hungary
Hong Kong
United States
India
Belgium
China
Malaysia
Egypt
Norway
Singapore
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


lead_sponsor: Novartis Pharmaceuticals

summary: This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

ReferenceCitation: Andre F, O'Regan R, Ozguroglu M, Toi M, Xu B, Jerusalem G, Masuda N, Wilks S, Arena F, Isaacs C, Yap YS, Papai Z, Lang I, Armstrong A, Lerzo G, White M, Shen K, Litton J, Chen D, Zhang Y, Ali S, Taran T, Gianni L. Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 May;15(6):580-91. doi: 10.1016/S1470-2045(14)70138-X. Epub 2014 Apr 14.

location_facility: Longview Cancer Center Longview Cancer Center (2)

location_facility: Comprehensive Cancer Center - Boca Raton Deerfield Beach

location_facility: Swedish Cancer Institute Swedish Cancer Institute

location_facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)

location_facility: Duke University Medical Center Dept. of DUMC (2)

location_facility: Park Nicollet Institute Dept. of Park Nicollet

location_facility: Virginia Oncology Associates Dept. of VOA (2)

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Nevada Cancer Institute Dept. of Nevada Cancer (3)

location_facility: Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr

location_facility: University of Arizona / Cancer Center AZ Onc Assoc

location_facility: University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)

location_facility: University of Texas Southwestern Medical Center University of TX SW Med Ctr(2)

location_facility: Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

location_facility: Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2)

location_facility: Texas Oncology Presbyterian Hospital (2)

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6)

location_facility: Memorial Hospital Memorial Cancer Institute

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

location_facility: Virginia Cancer Specialists Fairfax No.VA (2)

location_facility: University of Texas/MD Anderson Cancer Center SC-5

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

location_facility: Kansas City Cancer Center KCCC- South (2)

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

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

location_facility: The Jones Clinic Dept .of The Jones Clinic (3)

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: St. Louis University Cancer Center SLU Cancer Center

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)

location_facility: University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2)

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

location_facility: North Shore University Health System NSU

title: A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer.

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Turkey
France
Czech Republic
Slovakia
Hungary
United States
Belgium
China
Italy
United Kingdom
Singapore
Mexico
Spain
Greece
Israel


title: A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma

summary: The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.

status: Terminated

lead_sponsor: Eli Lilly and Company

location_country:
Finland
Germany
Italy
Poland
Israel
Norway
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

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.

status_simplified: Unknown


title: Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control

acronym: EuroTrans

summary: The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

ReferenceCitation: Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. doi: 10.1093/bja/aem102. Erratum In: Br J Anaesth. 2008 Jan;100(1):146.

lead_sponsor: Janssen-Cilag International NV

sponsor_collaborators:
Janssen-Cilag International NV
Alza Corporation, DE, USA

location_country:
Germany
Ireland
United Kingdom
Denmark
Sweden
Switzerland
Austria
Belgium
Spain
France


lead_sponsor: Bial - Portela C S.A.

summary: The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an effective adjunct therapy in the treatment of refractory partial seizures

ReferenceCitation: Andermann E, Rosenfeld W, Penovich P, Rogin J, Cendes F, Carreno M, Ramsay RE, Ben-Menachem E, Gama H, Rocha F, Soares-da-Silva P, Tosiello R, Blum D, Grinnell T. Comparative analysis of the safety and tolerability of eslicarbazepine acetate in older (>/=60 years) and younger (18-59 years) adults. Epilepsy Res. 2021 Jan;169:106478. doi: 10.1016/j.eplepsyres.2020.106478. Epub 2020 Oct 10.

ReferenceCitation: Cramer JA, Colman S, Anastassopoulos KP, Grinnell T, Mehta D, Williams GR. Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results. Epilepsy Behav. 2020 Nov;112:107312. doi: 10.1016/j.yebeh.2020.107312. Epub 2020 Aug 12.

sponsor_collaborators:
Bial - Portela C S.A.
Sumitomo Pharma America, Inc.

location_facility: UTSWMC Department of Neurology, Division of Epilepsy Research

location_facility: Centro de Neurologia y Neurorehabilitacion

location_facility: Wojewódzki Szpital Specjalistyczny w Lublinie Oddzial Neurologii

location_facility: Regional Epilepsy Centre of Aurora Healthcare- St. Luke's Medical Centre

location_facility: Consultants in Epilepsy and Neurology, PPLC

location_facility: Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge

location_facility: Temple University School of Medicine - Department of Neurology

location_facility: MGH Epilepsy Service Massachusetts, General Hospital

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: University of Toledo - Health Science Campus

location_facility: Kern County Neurological Medical Group, INC.

location_facility: University Washington Regional Epilepsy Center Harborview

location_facility: Phoenix Neurological Associates/Clinical Research Advantage

location_facility: Childrens Hospital of Pittsburg of UPMC - Division of Child Neurology

location_facility: Scott and White Memorial Hospital Sherwood and Brindley Foundation

location_facility: Wayne State University/Detroit Medical Center

location_facility: Università degli Studi di Napoli Policlinico Federico II

location_facility: Azienda Universitatia Ospedaliera San Giovanni Battista

location_facility: University of Arizona Health Sciences Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: Azienda Ospedaliero - Universitaria Maggiore della Carità

location_facility: Medical College of Wisconsin - Department of Neurology

location_facility: The Comprehensive Epilepsy Care Centre for Chidren and Adults

location_facility: Hospital Privado de la comunidad de Mar de Plata

location_facility: Centro Neurológico de Tratamiento y Rehabilitación

location_facility: Charite, Universitätsmedizin Berlin, CVK

location_facility: Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna

location_facility: University of Miami - Miller School of Medicine Department of Neurology

location_facility: University of Calgary Clinical Neurosciences

location_facility: Università Cattolica del Sacro Cuore Policlinico "A. Gemelli"

location_facility: Klinik und Poliklinik für Neurologie der Universität Regensburg im Bezirksklinikum

location_facility: Palm Beach Clinical Research Network, LLC.

location_facility: NZOZ "NEURO - KARD,"Ilkowski I Partnerzy Spólka, Partnerska Lekarzy

location_facility: CENTRE HOSPITALIER PELLEGRIN, CHU de BORDEAUX

location_facility: Neurological Associates of Washington/Clinical Trials of America, Inc

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Southern Ilinois University School of Medicine

location_facility: 21st Century Neurology - Division of Xenoscience, Inc.

location_facility: Pediatric Epilepsy & Neurology Specialists, PA

location_facility: Hopital Femme-Mere-Enfant, Hospices Civils de Lyon

location_facility: Strong Epilepsy Center - University of Rochester Medical Center

location_facility: Klinik für Neurologie, Klinische Neurophysiologie und Stroke Unit

location_facility: Azienda Ospedaliero, Universitaria "Ospedali Riuniti", Clinica della Malattie del Sistema Nervoso, Università di Foggia

location_facility: University of Florida Department of Neurology

location_facility: Wiell Cornell Medical Centre Epilepsy Centre

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Neurologii

location_facility: University of South Florida - Department of Neurology

location_facility: UMDNJ-Robert Wood Johnson Medical School

location_facility: Sentara Medical Group, Neurology Specialists Sentara Heart Hospital

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Barrow Neurological Institute / St. Joseph's Hospital and Medical Center

location_facility: University of South Alabama Department of Neurology

location_facility: Hopital Gui de Chauliac, Chu de Montpellier

location_facility: Albany Medical College - Neurosciences Institute

location_facility: Dean & St. Mary's Outpatient Center Neurological Institute and Spine Center

location_facility: University of Virginia - Comprehensive Epilepsy Program

location_facility: Comprehensive Epilepsy Center - Thomas Jefferson University

location_facility: General Hospital of Thessaloniki "Papanikolaou"

location_facility: Hospital Privado - Centro Médico de Córdoba S.A.

title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Trial

location_country:
Germany
Italy
Cyprus
Poland
Argentina
Brazil
Belgium
United States
Greece
Canada
France


lead_sponsor: Bayer

summary: Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

ReferenceCitation: Worden F, Fassnacht M, Shi Y, Hadjieva T, Bonichon F, Gao M, Fugazzola L, Ando Y, Hasegawa Y, Park DJ, Shong YK, Smit JW, Chung J, Kappeler C, Meinhardt G, Schlumberger M, Brose MS. Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer. Endocr Relat Cancer. 2015 Dec;22(6):877-87. doi: 10.1530/ERC-15-0252.

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

repository_institution: Radboud University - Radboud Repository

publisher_dissemination: Bioscientifica

ReferenceCitation: Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Pena C, Molnar I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. doi: 10.1016/S0140-6736(14)60421-9. Epub 2014 Apr 24.

ReferenceCitation: Brose MS, Nutting CM, Sherman SI, Shong YK, Smit JW, Reike G, Chung J, Kalmus J, Kappeler C, Schlumberger M. Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer. 2011 Aug 11;11:349. doi: 10.1186/1471-2407-11-349.

ReferenceCitation: Brose MS, Schlumbeger M, Jeffers M, Kappeler C, Meinhardt G, Pena CEA. Analysis of Biomarkers and Association With Clinical Outcomes in Patients With Differentiated Thyroid Cancer: Subanalysis of the Sorafenib Phase III DECISION Trial. Clin Cancer Res. 2019 Dec 15;25(24):7370-7380. doi: 10.1158/1078-0432.CCR-18-3439. Epub 2019 Sep 26.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Capdevila J, Matos I, Mancuso FM, Iglesias C, Nuciforo P, Zafon C, Palmer HG, Ogbah Z, Muinos L, Hernando J, Villacampa G, Pena CE, Tabernero J, Brose MS, Schlumberger M, Vivancos A. Identification of Expression Profiles Defining Distinct Prognostic Subsets of Radioactive-Iodine Refractory Differentiated Thyroid Cancer from the DECISION Trial. Mol Cancer Ther. 2020 Jan;19(1):312-317. doi: 10.1158/1535-7163.MCT-19-0211. Epub 2019 Sep 20.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

sponsor_collaborators: Bayer Amgen

title: A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Japan
Sweden
Netherlands
Austria
Belgium
United States
China
Korea, Republic of
Saudi Arabia
Spain
Bulgaria
Russian Federation
France


intervention_type: Biological

lead_sponsor: Pfizer

summary: People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.

ReferenceCitation: Cordonnier C, Ljungman P, Juergens C, Maertens J, Selleslag D, Sundaraiyer V, Giardina PC, Clarke K, Gruber WC, Scott DA, Schmoele-Thoma B; 3003 Study Group. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged >/=2 years: an open-label study. Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

location_facility: Steven and Alexandra Cohen Children's Medical Center of New York

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hopital Robert Debre - Service Pharmacie

location_facility: Universitetssjukhuset i Lund, Barnonkologen Avd 64

location_facility: Columbia University Medical Center Research Pharmacy

location_facility: Fakultni nemocnice Brno/Interni hematoonkologicka klinika

location_facility: New York-Presbyterian Morgan Stanley Children's Hospital

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

location_facility: Columbia University Medical Center-Presbyterian Hospital Building

location_facility: Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej

location_facility: UMC Utrecht, Wilhelmina Kinder Ziekenhuis

location_facility: Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie

location_facility: Columbia University/Taub Institute Irving Center for Clinical Research

location_facility: Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg

location_facility: Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH

title: A Phase 3, Open-label Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Followed By 23-valent Pneumococcal Polysaccharide Vaccine In Recipients Of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years And Older

primary_purpose: Prevention

design_allocation: Non-Randomized

location_country:
Germany
Poland
Sweden
Netherlands
Belgium
United States
Spain
Czechia
Canada
France


summary: This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

location_facility: Cedars Sinai Medical Center The Pituitary Center (3)

location_facility: Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)

location_facility: Mount Sinai School of Medicine Study Coordinator

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)

title: An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin

location_country:
Germany
Italy
Argentina
Australia
Brazil
Mexico
United States
Spain
Thailand
Canada
Russian Federation
France


title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling.

summary:
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling.

The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following:

Death (all causes).
New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA).

An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

ReferenceCitation: Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Nowbakht P, Roux S, Kassell N. Randomized trial of clazosentan in patients with aneurysmal subarachnoid hemorrhage undergoing endovascular coiling. Stroke. 2012 Jun;43(6):1463-9. doi: 10.1161/STROKEAHA.111.648980. Epub 2012 Mar 8. Erratum In: Stroke. 2012 Jul;43(7):e68.

ReferenceCitation: Mayer SA, Aldrich EF, Bruder N, Hmissi A, Macdonald RL, Viarasilpa T, Marr A, Roux S, Higashida RT. Thick and Diffuse Subarachnoid Blood as a Treatment Effect Modifier of Clazosentan After Subarachnoid Hemorrhage. Stroke. 2019 Oct;50(10):2738-2744. doi: 10.1161/STROKEAHA.119.025682. Epub 2019 Aug 9.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Slovenia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Belgium
Italy
Norway
Singapore
Sweden
Netherlands
Austria
Mexico
Spain
Taiwan
Israel

location_facility: State University of New York at Stony Brook

location_facility: The Neuroscience Center, Copenhagen University Hospital

location_facility: Thomas Jefferson University School of Medicine

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: New York Presbyteruan Hospital - Weill Cornell Medical Centre

location_facility: Hospital Clinico Pontificia Universidad Católica de Chile

location_facility: University of Texas Southwestern Zale Lipshy Hospital

location_facility: University of Pecs, Faculty of Medicine Neurosurgery Clinic

location_facility: University of Calgary - Foothills Medical Center

location_facility: University Fur Neurochirurgie, SALK, Christian Doppler Hospital

location_facility: Complejo Hospotalario Virgen de las Nieves-Hospital de Rehabilitacion y Traumatologia

location_facility: Universitatsklinikum Augsburg Clinic for Diagnostic Radiology and Neuroradiology

location_facility: Capital Health System Inc. d/b/a The Stroke and Cerebrovascular Center of New Jersey

location_facility: Oklahoma University Health Sciences Center

location_facility: Azienda Osepedaliera San Giovanni - Addolorata

location_facility: Neuroradiologie der Universitatsklinik Freiburg

location_facility: University of Szeged, Faculty of Medicine

location_facility: Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital

location_facility: QEII Heath Sciences Center - Halifax Infirmary

location_facility: Hopital neurologique et Neuro-Chirurgical Pierre Wertheimer

location_facility: Tampere University Central Hospital (TAYS)

location_facility: Virginia Commonwealth University Medical Centre

location_facility: Universitatsklinik Frankfurt, Klinik und Poliklinik f. Neurochirurgie

location_facility: St. Michael's Hospital, University of Toronto

location_facility: Klinik imd Poliklinik fur Neurochirurgie

location_facility: Universitaet Erlangen-Nuerberg Klinik fur Neurologie

location_facility: Landeskrankenhaus und Medizinische Universitat

location_facility: AKH University of Vienna, Medical Univ. Of Neurosurgery

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczy w Warszawie

location_facility: Hospital de Clinicas da Universidade Federal do Parana

location_facility: Thechnical University - Klinikum rechts der Isar

location_facility: Klinik und Poliklinik fur Neurochirurgie

location_facility: Neurochirurggische Universitatsklinik des Heidelberg

location_facility: University Hospitals Case Medical Center

location_facility: Haukeland University Hospital, Helse Bergen HF

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Universidad Autonoma de Nuevo Leon

location_facility: Instituto Nacional de Neurologia y Neurocirugia


type: Registry Identifier

title: TK008: Randomized Phase III Trial of Haploidentical HCT With or Without an Add Back Strategy of HSV-Tk Donor Lymphocytes in Patients With High Risk Acute Leukemia

summary: The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT

ipd_sharing_description: No, only information requested by law will be released

lead_sponsor: AGC Biologics S.p.A.

location_country:
Germany
Italy
Lithuania
Portugal
Israel
Belgium
United States
Spain
Greece
France

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Presidio Molinette

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle

location_facility: Policlinico G. B. Rossi, Azienda ospedaliera universitaria integrata di Verona

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: IUCT Oncopole - Institut Universitaire du Cancer de Toulouse

intervention_type: Other


acronym: ASTRONAUT

summary: This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

ReferenceCitation: Vaduganathan M, Cheema B, Cleveland E, Sankar K, Subacius H, Fonarow GC, Solomon SD, Lewis EF, Greene SJ, Maggioni AP, Bohm M, Zannad F, Butler J, Gheorghiade M. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial. Eur J Heart Fail. 2018 Apr;20(4):677-686. doi: 10.1002/ejhf.973. Epub 2017 Nov 16.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Greene SJ, Butler J, Fonarow GC, Subacius HP, Ambrosy AP, Vaduganathan M, Triggiani M, Solomon SD, Lewis EF, Maggioni AP, Bohm M, Chioncel O, Nodari S, Senni M, Zannad F, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Pre-discharge and early post-discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial. Eur J Heart Fail. 2018 Feb;20(2):281-291. doi: 10.1002/ejhf.1019. Epub 2017 Oct 17.

ReferenceCitation: Lund LH, Trochu JN, Meyns B, Caliskan K, Shaw S, Schmitto JD, Schibilsky D, Damme L, Heatley J, Gustafsson F. Screening for heart transplantation and left ventricular assist system: results from the ScrEEning for advanced Heart Failure treatment (SEE-HF) study. Eur J Heart Fail. 2018 Jan;20(1):152-160. doi: 10.1002/ejhf.975. Epub 2017 Sep 27.

ReferenceCitation: Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum In: JAMA. 2013 Apr 10;309(14):1461.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

publisher_dissemination: American Medical Association

ReferenceCitation: Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Bohm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A; ASTRONAUT investigators and study coordinators. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail. 2011 Jan;13(1):100-6. doi: 10.1093/eurjhf/hfq209. Epub 2010 Nov 30.

title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure

location_country:
Finland
Germany
Poland
Argentina
Brazil
Turkey
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
United States
India
Romania
Belgium
Philippines
Italy
Singapore
Sweden
Spain
Taiwan
Russian Federation
Israel


title: A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection

summary: This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.

ReferenceCitation: Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.

location_country:
Germany
Italy
United Kingdom
Australia
Austria
United States
Spain
Canada
Puerto Rico
France


summary: The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

sponsor_collaborators:
Pfizer
UCB Pharma

location_facility: Severance Hospital, Yonsei University Health System

location_facility: UT Southwestern University Hospital - St. Paul

location_facility: The University of Texas, M. D. Anderson Cancer Center

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Washington University School of Medicine

location_facility: Departement d'Hematologie et d'Oncologie-

location_facility: Memorial Sloan - Kettering Cancer Center

location_facility: Loyola University Medical Center, Foster G. McGraw Hospital and Satellites

location_facility: Penn State Milton S Hershey Medical Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)

location_facility: University of Michigan Comprehensive Cancer Center

title: An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation

location_country:
Germany
United Kingdom
Singapore
United States
Korea, Republic of
France


acronym: MISSION

summary: The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

title: A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Pakistan
Chile
Canada
France
Hungary
Hong Kong
United States
Indonesia
India
Belgium
China
Peru
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

ReferenceCitation: Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

ReferenceCitation: Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.

ReferenceCitation: Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

ReferenceCitation: Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

publisher_dissemination: British Medical Journal

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.

repository_institution: Imperial College London - Spiral

ReferenceCitation: Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. doi: 10.4143/crt.2015.278. Epub 2016 Feb 24.

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Korean Cancer Association

ReferenceCitation: Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. doi: 10.1007/s00535-016-1204-2. Epub 2016 Apr 22.

ReferenceCitation: Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.

ReferenceCitation: Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.

ReferenceCitation: Kim NH, D'Armini AM, Grimminger F, Grunig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

location_facility:
Vseobecna fakultni nemocnice
Hopital Antoine Beclere

title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Slovakia
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


title: Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary: The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.

ReferenceCitation: Grob JJ, Mortier L, D'Hondt L, Grange F, Baurain JF, Dreno B, Lebbe C, Robert C, Dompmartin A, Neyns B, Gillet M, Louahed J, Jarnjak S, Lehmann FF. Safety and immunogenicity of MAGE-A3 cancer immunotherapeutic with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma: an open phase I/II study with a first assessment of a predictive gene signature. ESMO Open. 2017 Nov 14;2(5):e000203. doi: 10.1136/esmoopen-2017-000203. eCollection 2017.

lead_sponsor: GlaxoSmithKline

location_country: Belgium France


summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

ReferenceCitation: Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

ReferenceCitation: Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

ReferenceCitation: Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

repository_institution: University College London - UCL Discovery

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


acronym: BIBF 1120 plus docetaxel in 2nd line NSCLC

lead_sponsor: Boehringer Ingelheim

summary: The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

ReferenceCitation: Gottfried M, Bennouna J, Bondarenko I, Douillard JY, Heigener DF, Krzakowski M, Mellemgaard A, Novello S, Orlov S, Summers Y, von Pawel J, Stohr J, Kaiser R, Reck M. Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study. Target Oncol. 2017 Aug;12(4):475-485. doi: 10.1007/s11523-017-0517-2.

publisher_dissemination: Springer-Nature

ReferenceCitation: Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowski M, von Pawel J, Gottfried M, Bondarenko I, Liao M, Gann CN, Barrueco J, Gaschler-Markefski B, Novello S; LUME-Lung 1 Study Group. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol. 2014 Feb;15(2):143-55. doi: 10.1016/S1470-2045(13)70586-2. Epub 2014 Jan 9.

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

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: GUZ Sverdlovsky Regional Oncology Dispensary

location_facility: Allgemeines Krankenhaus Harburg, 21075 Hamburg

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

location_facility: Ternopil regional communal clinical oncology centre

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven

location_facility: District Hospital Pribram, Oncology Centrum

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: University Hospital of Heraklion, University Pulmonology Cl

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

location_facility: Emergency County Hospital "Sf.loan cel Nou"

location_facility: Kharkiv Medical Acadamy of Postgraduate education

location_facility: Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

location_facility: The Third Affiliated Hospital of Harbin Medical University

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

location_facility: Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr

location_facility: GUZ "Regional Clinical Oncology Dispensary"

location_facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

location_facility: RBIH "Kursk regional clinical oncology dispensary"

location_facility: Uzhgorod National University, Oncology Centre

location_facility: GUZ Regional Oncology Dispensary, Magnitogorsk

location_facility: Multiprofile Hospital for Active Treatment

location_facility: Universitätsklinikum Benjamin Franklin, Berlin

location_facility: Sainte Anne Training hospital for the armies

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"

location_facility: Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich, Augsburg

location_facility: SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary"

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: St. Anna Hospital, 2nd Internal Department

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar

location_facility: Athens Hospital of Chest Diseasea "SOTIRIA"

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: Papageorgiou Hospital, 1st Cardiological Cl., Thessaloniki

location_facility: First Affiliated Hospital of Dalian Medical University

location_facility: City Cancer Centre, Cancer Hospital & Research

location_facility: GUZ Irkutsk Regional Oncology Dispensary

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Public Health Inst. Minsk City Clinical Oncology Dispensary

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

location_facility: B. P .Poddar Hospital & Medical Research Ltd.

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: Institute of Tuberculosis & Pulmonology, III. Dept., Olsztyn

location_facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: CHU de Rouen - Hôpital de Bois Guillaume

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie, Köln

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Universitätsklinik links der Isar, München, Ziemssenstr. 1

location_facility: Specialized Hospital for Active Treatment in Oncolcogy

location_facility: Institut onkologie a rehabilitace Na Plesi s.r.o.

location_facility: Jawaharlal Nehru Cancer Hospital & Research Centre

location_facility: Kryvorizskyi regional communal clinical oncology centre

location_facility: Emergency Clinical County Hospital "Sf Spiridon", Iasi

location_facility: Clinical Hospital Centar Sestre Milosrdnice

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

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

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

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

location_facility: Fundación Instituto Valenciano de Oncologia

title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

location_country:
Germany
Poland
Croatia
Czechia
France
Belarus
Lithuania
Portugal
Slovakia
Denmark
Switzerland
Ukraine
India
Romania
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Georgia
Russian Federation
Israel


summary: This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.

ReferenceCitation: Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.

publisher_dissemination: Informa

ReferenceCitation: Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.

ReferenceCitation: Gridelli C, de Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Middleton G, Corral J, Winfree K, Melemed S, Zimmermann A, John W, Beyrer J, Chouaki N, Visseren-Grul C, Paz-Ares LG. Safety, resource use, and quality of life in paramount: a phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2012 Nov;7(11):1713-21. doi: 10.1097/JTO.0b013e318267cf84.

ReferenceCitation: Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.

ReferenceCitation: Paz-Ares LG, Altug S, Vaury AT, Jaime JC, Russo F, Visseren-Grul C. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. BMC Cancer. 2010 Mar 8;10:85. doi: 10.1186/1471-2407-10-85.

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.

title: A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.

location_country:
Finland
Germany
Italy
Poland
India
Portugal
United Kingdom
Romania
Australia
Netherlands
Belgium
Spain
Greece
Turkey
France