title: A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

acronym: TERI-PRO

summary:
Primary Objective:

To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).

Secondary Objectives:

To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.

To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting).

To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.

To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

ReferenceCitation: Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Poole EM, Robinson M, Gold R. Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study. Mult Scler Relat Disord. 2019 Jun;31:157-164. doi: 10.1016/j.msard.2019.03.022. Epub 2019 Mar 30.

ReferenceCitation: Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Brette S, Robinson M, Gold R; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6.

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Sweden
Austria
Belgium
United States
Spain
Greece
Chile
Canada
France

location_facility:
Investigational Site Number 840028
Investigational Site Number 250038
Investigational Site Number 250037
Investigational Site Number 840012
Investigational Site Number 578002
Investigational Site Number 826-006
Investigational Site Number 250008
Investigational Site Number 276003
Investigational Site Number 056007
Investigational Site Number 300004
Investigational Site Number 724004
Investigational Site Number 840080
Investigational Site Number 724008
Investigational Site Number 840098
Investigational Site Number 840075
Investigational Site Number 124006
Investigational Site Number 840070
Investigational Site Number 250028
Investigational Site Number 840003
Investigational Site Number 056008
Investigational Site Number 724001
Investigational Site Number 250009
Investigational Site Number 840074
Investigational Site Number 840038
Investigational Site Number 840064
Investigational Site Number 124007
Investigational Site Number 250019
Investigational Site Number 840068
Investigational Site Number 250015
Investigational Site Number 250026
Investigational Site Number 300005
Investigational Site Number 840018
Investigational Site Number 840020
Investigational Site Number 840101
Investigational Site Number 724005
Investigational Site Number 840055
Investigational Site Number 040-002
Investigational Site Number 840049
Investigational Site Number 056003
Investigational Site Number 250031
Investigational Site Number 152005
Investigational Site Number 250007
Investigational Site Number 840108
Investigational Site Number 250002
Investigational Site Number 056006
Investigational Site Number 250029
Investigational Site Number 840002
Investigational Site Number 040-001
Investigational Site Number 840037
Investigational Site Number 250013
Investigational Site Number 840014
Investigational Site Number 724007
Investigational Site Number 250033
Investigational Site Number 840091
Investigational Site Number 380008
Investigational Site Number 826-007
Investigational Site Number 840040
Investigational Site Number 840047
Investigational Site Number 152003
Investigational Site Number 056005
Investigational Site Number 250022
Investigational Site Number 840060
Investigational Site Number 840054
Investigational Site Number 840017
Investigational Site Number 840072
Investigational Site Number 250011
Investigational Site Number 840024
Investigational Site Number 380006
Investigational Site Number 250025
Investigational Site Number 300002
Investigational Site Number 840021
Investigational Site Number 840041
Investigational Site Number 250018
Investigational Site Number 840069
Investigational Site Number 250027
Investigational Site Number 826-003
Investigational Site Number 250023
Investigational Site Number 840044
Investigational Site Number 724010
Investigational Site Number 826-004
Investigational Site Number 380009
Investigational Site Number 250030
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 250004
Investigational Site Number 250035
Investigational Site Number 250032
Investigational Site Number 840114
Investigational Site Number 840030
Investigational Site Number 724006
Investigational Site Number 246006
Investigational Site Number 250040
Investigational Site Number 840032
Investigational Site Number 246003
Investigational Site Number 840105
Investigational Site Number 840059
Investigational Site Number 250024
Investigational Site Number 840048
Investigational Site Number 826-010
Investigational Site Number 250005
Investigational Site Number 246005
Investigational Site Number 840100
Investigational Site Number 840087
Investigational Site Number 250016
Investigational Site Number 250020
Investigational Site Number 840046
Investigational Site Number 826-008
Investigational Site Number 840090
Investigational Site Number 250012
Investigational Site Number 276001
Investigational Site Number 840076
Investigational Site Number 826-005
Investigational Site Number 752003
Investigational Site Number 752002
Investigational Site Number 276004
Investigational Site Number 840078
Investigational Site Number 840045
Investigational Site Number 840077
Investigational Site Number 246004
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840053
Investigational Site Number 250021
Investigational Site Number 380005
Investigational Site Number 840112
Investigational Site Number 840042
Investigational Site Number 840089
Investigational Site Number 840016
Investigational Site Number 840109
Investigational Site Number 056002
Investigational Site Number 724002
Investigational Site Number 250039
Investigational Site Number 300001
Investigational Site Number 840097
Investigational Site Number 056009
Investigational Site Number 840081
Investigational Site Number 840073
Investigational Site Number 250006
Investigational Site Number 840104
Investigational Site Number 840094
Investigational Site Number 840034
Investigational Site Number 840007
Investigational Site Number 840058
Investigational Site Number 250001
Investigational Site Number 826-009
Investigational Site Number 840019
Investigational Site Number 380001
Investigational Site Number 840035
Investigational Site Number 246001
Investigational Site Number 840107
Investigational Site Number 380004
Investigational Site Number 826-001
Investigational Site Number 840084
Investigational Site Number 840056
Investigational Site Number 840071
Investigational Site Number 840086
Investigational Site Number 152001
Investigational Site Number 578001
Investigational Site Number 578003
Investigational Site Number 840052
Investigational Site Number 840010
Investigational Site Number 840079
Investigational Site Number 380002
Investigational Site Number 250017
Investigational Site Number 840011
Investigational Site Number 752001
Investigational Site Number 840005
Investigational Site Number 250043
Investigational Site Number 056001


type: EudraCT Number

title: Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)

acronym: AEGEAN

summary: The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators. Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2.

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

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
ddd.uab.cat

repositories_concat: HAL;PubMed Central;ddd.uab.cat

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
Switzerland
Belgium
Spain
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

acronym: SATURN

summary: The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

primary_purpose: Treatment

ReferenceCitation: Van Kerrebroeck P, Haab F, Angulo JC, Vik V, Katona F, Garcia-Hernandez A, Klaver M, Traudtner K, Oelke M. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013 Sep;64(3):398-407. doi: 10.1016/j.eururo.2013.03.031. Epub 2013 Mar 19.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
Germany
Poland
Portugal
Slovakia
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Spain
Czech Republic
Russian Federation
France


title: A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.

summary: The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

ReferenceCitation: Kindler HL, Ioka T, Richel DJ, Bennouna J, Letourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.

lead_sponsor: Pfizer

location_country:
Germany
Ireland
Argentina
Australia
Japan
Canada
France
Hungary
Hong Kong
Switzerland
United States
India
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden


type: Other Identifier

title: A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

summary: This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

ReferenceType: result

ReferenceCitation: Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012 Apr;12(4):281-9. doi: 10.1016/S1473-3099(11)70374-7. Epub 2012 Feb 8.

ReferenceCitation: D'Agostino RB Sr, Collins SH, Pencina KM, Kean Y, Gorbach S. Risk estimation for recurrent Clostridium difficile infection based on clinical factors. Clin Infect Dis. 2014 May;58(10):1386-93. doi: 10.1093/cid/ciu107. Epub 2014 Mar 5.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories_concat: CiteSeerX

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013 Jul 1;31(19):2493-9. doi: 10.1200/JCO.2012.45.5899. Epub 2013 May 28.

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S154-61. doi: 10.1093/cid/cis462.

ReferenceCitation: Figueroa I, Johnson S, Sambol SP, Goldstein EJ, Citron DM, Gerding DN. Relapse versus reinfection: recurrent Clostridium difficile infection following treatment with fidaxomicin or vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S104-9. doi: 10.1093/cid/cis357.

ipd_sharing: Yes

lead_sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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


lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

summary: A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.

ReferenceCitation: Cortes J, Digumarti R, Parikh PM, Wetzler M, Lipton JH, Hochhaus A, Craig AR, Benichou AC, Nicolini FE, Kantarjian HM; Omacetaxine 203 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7.

version: acceptedVersion

repositories_concat: PubMed Central

publisher_dissemination: Wiley

location_facility:
Teva Investigational Site 311
Teva Investigational Site 303
Teva Investigational Site 302
Teva Investigational Site 313
Teva Investigational Site 340
Teva Investigational Site 325
Teva Investigational Site 329
Teva Investigational Site 330
Teva Investigational Site 360
Teva Investigational Site 305
Teva Investigational Site 309
Teva Investigational Site 350
Teva Investigational Site 310
Teva Investigational Site 322
Teva Investigational Site 370
Teva Investigational Site 323
Teva Investigational Site 308
Teva Investigational Site 321
Teva Investigational Site 327
Teva Investigational Site 390
Teva Investigational Site 314
Teva Investigational Site 320
Teva Investigational Site 324
Teva Investigational Site 380
Teva Investigational Site 371
Teva Investigational Site 301
Teva Investigational Site 331
Teva Investigational Site 328
Teva Investigational Site 361

title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine Mepesuccinate; OMA) in the Treatment of Patients With Chronic Myeloid. Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy

source: euctr

location_country:
Germany
Italy
Poland
India
Hungary
Singapore
United Kingdom
United States
Canada
France

collaborators:
Cephalon
ChemGenex Pharmaceuticals


title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients

acronym: TIGRIS

summary: THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

status: Terminated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Bagai A, Ali FM, Gregson J, Alexander KP, Cohen MG, Sundell KA, Simon T, Westermann D, Yasuda S, Brieger D, Goodman SG, Nicolau JC, Granger CB, Pocock S. Multimorbidity, functional impairment, and mortality in older patients stable after prior acute myocardial infarction: Insights from the TIGRIS registry. Clin Cardiol. 2022 Dec;45(12):1277-1286. doi: 10.1002/clc.23915. Epub 2022 Nov 1.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

ReferenceCitation: Carnicelli AP, Owen R, Pocock SJ, Brieger DB, Yasuda S, Nicolau JC, Goodman SG, Cohen MG, Simon T, Westermann D, Hedman K, Andersson Sundell K, Granger CB. Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction. Open Heart. 2021 Dec;8(2):e001726. doi: 10.1136/openhrt-2021-001726.

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

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

repositories:
HAL
PubMed Central
researchonline.lshtm.ac.uk

publisher_dissemination: British Medical Journal

ReferenceCitation: Russo JJ, Yan AT, Pocock SJ, Brieger D, Owen R, Sundell KA, Bagai A, Granger CB, Cohen MG, Yasuda S, Nicolau JC, Brandrup-Wognsen G, Westermann D, Simon T, Goodman SG. Determinants of long-term dual antiplatelet therapy use in post myocardial infarction patients: Insights from the TIGRIS registry. J Cardiol. 2022 Apr;79(4):522-529. doi: 10.1016/j.jjcc.2021.10.024. Epub 2021 Nov 29.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Pocock S, Brieger DB, Owen R, Chen J, Cohen MG, Goodman S, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Hedman K, Mellstrom C, Andersson Sundell K, Grieve R. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis. Open Heart. 2021 Feb;8(1):e001499. doi: 10.1136/openhrt-2020-001499.

ReferenceCitation: Nicolau JC, Brieger D, Owen R, Furtado RHM, Goodman SG, Cohen MG, Simon T, Westermann D, Granger CB, Grieve R, Yasuda S, Chen J, Hedman K, Mellstrom C, Brandrup-Wognsen G, Pocock SJ. Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction. Clin Cardiol. 2020 Dec;43(12):1352-1361. doi: 10.1002/clc.23476. Epub 2020 Nov 4.

ReferenceCitation: Westermann D, Goodman SG, Nicolau JC, Requena G, Maguire A, Chen JY, Granger CB, Grieve R, Pocock SJ, Blankenberg S, Vega AM, Yasuda S, Simon T, Brieger D; TIGRIS Study Investigators. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study. Clin Cardiol. 2017 Dec;40(12):1197-1204. doi: 10.1002/clc.22837. Epub 2017 Dec 16.

ReferenceCitation: Goodman SG, Nicolau JC, Requena G, Maguire A, Blankenberg S, Chen JY, Granger CB, Grieve R, Pocock SJ, Simon T, Yasuda S, Vega AM, Brieger D; TIGRIS Study Investigators. Longer-term oral antiplatelet use in stable post-myocardial infarction patients: Insights from the long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease (TIGRIS) observational study. Int J Cardiol. 2017 Jun 1;236:54-60. doi: 10.1016/j.ijcard.2017.02.062. Epub 2017 Feb 21.

evidence: open (via crossref license, author manuscript)

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Colombia
Portugal
Denmark
United States
India
Romania
Belgium
China
Italy
Norway
United Kingdom
Venezuela
Netherlands
Mexico
Korea, Republic of
Spain


title: Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma

summary:
This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma.

The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Germany Poland Portugal Netherlands Belgium Spain France

location_facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

location_facility: Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Université Catholique de Louvain Saint Luc

location_facility: Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin

location_facility: Gemeinschaftspraxis für Hämatologie und internistische Onkologie

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol

location_facility: Hospital Universitario Central de Asturias

location_facility: Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

location_facility: Instituto Português de Oncologia de Lisboa de Francisco Gentil

location_facility: Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel

location_facility: Institute of Hematology and Transfusiology

location_facility: Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Internistische Praxis /Hämatologie und Onkologie

status_simplified: Ongoing


title: A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

summary: Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

ReferenceCitation: Almas M, Tepper SJ, Landy S, Schweizer E, Ramos E. Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study. Cephalalgia. 2014 Feb;34(2):126-35. doi: 10.1177/0333102413500726. Epub 2013 Aug 14.

publisher_dissemination: SAGE Publications

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country: Germany Italy Portugal Hungary Norway Denmark Sweden Netherlands Belgium Spain Greece Turkey Czechia France

location_facility: 1St Medical Faculty of the Charles University

location_facility: Hospital General Universitari Vall D�Hebron

location_facility: Fachklinik Fuer Neurologie Dietenbronn Gmbh

location_facility: Karadeniz Technical University Medical Faculty

location_facility: Hospital General Universitario J. M. Morales Meseguer

location_facility: Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna

location_facility: Hospital Universitari de Lleida Arnau de Vilanova

location_facility: Clinica Neurologica, Universita Di Perugia

location_facility: Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio

location_facility: Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico

location_facility: University of Debrecen, Medical and Health Science Centre, Medical School

location_facility: Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)

location_facility: Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)


lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

summary: This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

ReferenceType: background

ReferenceCitation: Gattone VH 2nd, Wang X, Harris PC, Torres VE. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nat Med. 2003 Oct;9(10):1323-6. doi: 10.1038/nm935. Epub 2003 Sep 21.

ReferenceCitation: Torres VE, Wang X, Qian Q, Somlo S, Harris PC, Gattone VH 2nd. Effective treatment of an orthologous model of autosomal dominant polycystic kidney disease. Nat Med. 2004 Apr;10(4):363-4. doi: 10.1038/nm1004. Epub 2004 Feb 29.

ReferenceCitation: Torres VE, Meijer E, Bae KT, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang JJ, Czerwiec FS. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study. Am J Kidney Dis. 2011 May;57(5):692-9. doi: 10.1053/j.ajkd.2010.11.029. Epub 2011 Feb 17.

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.

ReferenceCitation: Watkins PB, Lewis JH, Kaplowitz N, Alpers DH, Blais JD, Smotzer DM, Krasa H, Ouyang J, Torres VE, Czerwiec FS, Zimmer CA. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Saf. 2015 Nov;38(11):1103-13. doi: 10.1007/s40264-015-0327-3.

ReferenceCitation: Kher A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257-8. doi: 10.1056/NEJMc1300762. No abstract available.

ReferenceCitation: Spital A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257. doi: 10.1056/NEJMc1300762. No abstract available.

ReferenceCitation: Torres VE, Gansevoort RT, Czerwiec FS. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1259. doi: 10.1056/NEJMc1300762. No abstract available.

ReferenceCitation: Jouret F, Krzesinski JM. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258-9. doi: 10.1056/NEJMc1300762. No abstract available.

ReferenceCitation: Sexton DJ. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258. doi: 10.1056/NEJMc1300762. No abstract available.

ReferenceCitation: Nowak KL, Steele C, Gitomer B, Wang W, Ouyang J, Chonchol MB. Overweight and Obesity and Progression of ADPKD. Clin J Am Soc Nephrol. 2021 Jun;16(6):908-915. doi: 10.2215/CJN.16871020. Epub 2021 Jun 11.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Heida JE, Gansevoort RT, Torres VE, Devuyst O, Perrone RD, Lee J, Li H, Ouyang J, Chapman AB. The Effect of Tolvaptan on BP in Polycystic Kidney Disease: A Post Hoc Analysis of the TEMPO 3:4 Trial. J Am Soc Nephrol. 2021 Jul;32(7):1801-1812. doi: 10.1681/ASN.2020101512. Epub 2021 Apr 22.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

repositories_concat: PubMed Central;pure.rug.nl

ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

ReferenceCitation: McEwan P, Bennett Wilton H, Ong ACM, Orskov B, Sandford R, Scolari F, Cabrera MV, Walz G, O'Reilly K, Robinson P. A model to predict disease progression in patients with autosomal dominant polycystic kidney disease (ADPKD): the ADPKD Outcomes Model. BMC Nephrol. 2018 Feb 13;19(1):37. doi: 10.1186/s12882-017-0804-2.

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

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Dandurand A, Ouyang J, Czerwiec FS, Blais JD; TEMPO 4:4 Trial Investigators. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrol Dial Transplant. 2018 Mar 1;33(3):477-489. doi: 10.1093/ndt/gfx043.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Muto S, Kawano H, Higashihara E, Narita I, Ubara Y, Matsuzaki T, Ouyang J, Torres VE, Horie S. The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. Clin Exp Nephrol. 2015 Oct;19(5):867-77. doi: 10.1007/s10157-015-1086-2. Epub 2015 Feb 7.

location_facility: Sussex Renal Unit Royal Sussex County Hospital

location_facility: Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay

location_facility: Klinik für Nieren- und Hochdruckkrankheiten

location_facility: Jacksonville Center for Clinical Research

location_facility: Coastal Nephrology Associates Research Center, LLC

location_facility: Tokyo Women's Medical University Hospital

location_facility: Queen Elizabeth II Health Science Center, Division of Nephrology

location_facility: University of North Carolina, UNC, Kidney Center

location_facility: University of Pennsylvania Medical Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: Università Vita e Salute, Ospedale San Raffaele

location_facility: University of Colorado Health Sciences Center

location_facility: Szpital Praski, Samodzielny Publiczny ZOZ

location_facility: Tokyo Medical & Dental University Hospital, Faculty of Medicine

location_facility: Klinika Chorób Wewnętrznych i Nefrologii

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Hospital Privado-Centro Medico de Cordoba

location_facility: Akademicki Szpital Kliniczny im J Mikulicza Radeckiego

location_facility: Spitalul Clinic de Nefrologie Dr. Carol Davila

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG

location_facility: Kemerovo Medical Academy, Regional Clinical Hospital

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Royal Free and University College Medical School

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: University of Virginia, Nephrology Clinical Research Center

location_facility: Międzyleski Szpital Specjalistyczny w Warszawie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie

title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Denmark
Australia
Japan
Netherlands
Romania
Belgium
United States
Canada
Russian Federation
France


acronym: Depsipeptide in PTCL

lead_sponsor: Celgene

summary: The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.

ReferenceCitation: Foss F, Pro B, Miles Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Med. 2017 Jan;6(1):36-44. doi: 10.1002/cam4.939. Epub 2016 Dec 16.

ReferenceCitation: Shustov A, Coiffier B, Horwitz S, Sokol L, Pro B, Wolfson J, Balser B, Eisch R, Popplewell L, Prince HM, Allen SL, Piekarz R, Bates S. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma. 2017 Oct;58(10):2335-2341. doi: 10.1080/10428194.2017.1295143. Epub 2017 Mar 7.

ReferenceCitation: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. doi: 10.1200/JCO.2011.37.4223. Epub 2012 Jan 23.

ReferenceCitation: Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of (1)(8)fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Apr;26(4):774-779. doi: 10.1093/annonc/mdv010. Epub 2015 Jan 20.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

repository_normalized: LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. doi: 10.1186/s13045-016-0243-8. Erratum In: J Hematol Oncol. 2017 Sep 18;10 (1):154.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;jdc.jefferson.edu

ReferenceCitation: Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.

ReferenceCitation: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7:11. doi: 10.1186/1756-8722-7-11.

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Klinikum der Universitat Munchen-Grosshadern

location_facility: Consultants in Blood Disorders and Cancer

location_facility: National Cancer Institute Department Of Conservative Methods Of Treatment

location_facility: Klinika Hematologii Akademickie Centrum Kliniczne Akademii Medycznej w Gdansku

location_facility: University of Texas Health Science Center at San Antonio

location_facility: UT Southwestern Medical Center Simmons Comprehensive Cancer Center

location_facility: Hematology Oncology Assoc. of IL Orchard Research LLC

location_facility: Winship Cancer Institute of Emory University

location_facility: University Hospital of Kralovske Vinohrady

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: Charite Universitatsmedizin Berlin campus Virchow Klinikum Centrum fur Tumormedizin

location_facility: Taussig Cancer Center Cleveland Clinic Foundation

location_facility: Mater Private Medical Centre - Haematology and Oncology Clinics of Australasia Research Centre

location_facility: Accelerated Community Oncology Research Network Inc ACORN

location_facility: Catherine Lewis Centre - Hematology Department

location_facility: R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology

location_facility: H. Lee Moffitt Cancer Center and Research Institute

title: A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy (GPI-06-0002)

location_country:
Germany
Poland
United Kingdom
Australia
Sweden
United States
Spain
Czechia
Ukraine
France


acronym: RELIEF

lead_sponsor: Bayer

summary: Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.

ReferenceCitation: Gyssens IC, Dryden M, Kujath P, Nathwani D, Schaper N, Hampel B, Reimnitz P, Alder J, Arvis P. A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections. J Antimicrob Chemother. 2011 Nov;66(11):2632-42. doi: 10.1093/jac/dkr344. Epub 2011 Sep 6.

ReferenceCitation: Schaper NC, Dryden M, Kujath P, Nathwani D, Arvis P, Reimnitz P, Alder J, Gyssens IC. Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Infection. 2013 Feb;41(1):175-86. doi: 10.1007/s15010-012-0367-x. Epub 2012 Nov 23.

ReferenceCitation: D'Onofrio V, Monnier AA, Kremer C, Stappers MHT, Netea MG, Gyssens IC. Lesion size is associated with genetic polymorphisms in TLR1, TLR6, and TIRAP genes in patients with major abscesses and diabetic foot infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):353-360. doi: 10.1007/s10096-019-03732-7. Epub 2019 Nov 30.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: UHasselt - Document Server@UHasselt

repository_institution: Radboud University - Radboud Repository

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

title: A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects With Complicated Skin and Skin Structure Infections

location_country:
Germany
Ireland
Poland
France
Lithuania
Hungary
Latvia
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel


title: A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma

summary: To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

lead_sponsor: Vical

location_country:
Germany
Italy
Poland
Israel
Brazil
Netherlands
Switzerland
Belgium
United States
Spain
Turkey
Canada
Russian Federation
France

location_facility:
Location #12
Location #19
Location #74
Location #45
Location #58
Location #95
Location #123
Location #117
Location #1
Location #66
Location #41
Location #27
Location #67
Location #47
Location #33
Location #87
Location #65
Location #111
Location #118
Location #84
Location #34
Location #51
Location #44
Location #122
Location #8
Location #26
Location #46
Location #99
Location #23
Location #94
Location #89
Location #60
Location #32
Location # 75
Location #124
Location #36
Location #81
Location #16
Location #55
Location #68
Location #82
Location #112
Location #100
Location #86
Location #72
Location #114
Location #110
Location #102
Location #38
Location #121
Location #35
Location #116
Location #103
Location #57
Location #37
Location #63
Location #79
Location #78
Location #59
Location #93
Location #4
Location #104
Location #43
Location #11
Location #62
Location #105
Location #40
Location #80
Location #9
Location #106
Location #109
Location #24
Location #115
Location #61
Location #28
Location #54
Location #97
Location #88
Location #52
Location #20
Location #50
Location #7
Location #113
Location #48
Location #85
Location #91
Location #101
Location #90


title: A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients

summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Turkey
Canada
France
Czech Republic
Colombia
Portugal
Slovakia
Hungary
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Panama
Russian Federation
Sweden


title: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

summary: This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

ReferenceCitation: Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.

lead_sponsor: Hoffmann-La Roche

location_country:
France
Italy
United Kingdom
Argentina
Romania
Australia
Brazil
Austria
Mexico
Bosnia and Herzegovina
Spain
Uruguay
Turkey
Canada
Russian Federation
Czech Republic


acronym: The REALM Study

summary: The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.

ReferenceCitation: Lim JK, Chang AY, Zaman A, Martin P, Fernandez-Rodriguez CM, Korkmaz M, Rossi S, Ford JM, Noonan T, Cooney E, Navarro V, Colombato L. Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B. J Clin Transl Hepatol. 2020 Dec 28;8(4):377-384. doi: 10.14218/JCTH.2020.00039. Epub 2020 Oct 10.

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Xia & He Publishing

ReferenceCitation: Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG. Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries. Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.

ReferenceCitation: Hou JL, Jia JD, Wei L, Zhao W, Wang YM, Cheng M, Tang X, Tan DM, Ren H, Tang H, Cohen D, Llamoso C. Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a 'real-world' clinical practice setting in China. J Viral Hepat. 2013 Nov;20(11):811-20. doi: 10.1111/jvh.12115.

location_facility: University Of Miami Center For Liver Diseases

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: Tulane University Health Sciences Center

title: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Turkey
Czechia
Canada
France
Colombia
Portugal
United States
India
Romania
China
Philippines
Italy
Singapore
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation


title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

summary: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

ReferenceCitation: Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.

lead_sponsor: AstraZeneca

location_country:
France
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Romania
Netherlands
Austria
Belgium
Spain
Andorra
Bulgaria
Russian Federation
Czech Republic

location_facility:
Almirall Investigational Sites#706
Almirall Investigational Sites#678
Almirall Investigational Sites#645
Almirall Investigational Sites#7
Almirall Investigational Sites#348
Almirall Investigational Sites#666
Almirall Investigational Sites#972
Almirall Investigational Sites#954
Almirall Investigational Sites#689
Almirall Investigational Sites#656
Almirall Investigational Sites#774
Almirall Investigational Sites#660
Almirall Investigational Sites#777
Almirall Investigational Sites#705
Almirall Investigational Sites#42
Almirall Investigational Sites#970
Almirall Investigational Sites#582
Almirall Investigational Sites#714
Almirall Investigational Sites#969
Almirall Investigational Sites#788
Almirall Investigational Sites#961
Almirall Investigational Sites#593
Almirall Investigational Sites#649
Almirall Investigational Sites#110
Almirall Investigational Sites#37
Almirall Investigational Sites#672
Almirall Investigational Sites#695
Almirall Investigational Sites#662
Almirall Investigational Sites#716
Almirall Investigational Sites#722
Almirall Investigational Sites#394
Almirall Investigational Sites#730
Almirall Investigational Sites#699
Almirall Investigational Sites#711
Almirall Investigational Sites#543
Almirall Investigational Sites#971
Almirall Investigational Sites#702
Almirall Investigational Sites#785
Almirall Investigational Sites#963
Almirall Investigational Sites#688
Almirall Investigational Sites#738
Almirall Investigational Sites#675
Almirall Investigational Sites#657
Almirall Investigational Sites#687
Almirall Investigational Sites#669
Almirall Investigational Sites#594
Almirall Investigational Sites#709
Almirall Investigational Sites#390
Almirall Investigational Sites#713
Almirall Investigational Sites#462
Almirall Investigational Sites#977
Almirall Investigational Sites#725
Almirall Investigational Sites#938
Almirall Investigational Sites#750
Almirall Investigational Sites#975
Almirall Investigational Sites#684
Almirall Investigational Sites#948
Almirall Investigational Sites#737
Almirall Investigational Sites#677
Almirall Investigational Sites#646
Almirall Investigational Sites#694
Almirall Investigational Sites#61
Almirall Investigational Sites#549
Almirall Investigational Sites#731
Almirall Investigational Sites#685
Almirall Investigational Sites#286
Almirall Investigational Sites#652
Almirall Investigational Sites#393
Almirall Investigational Sites#757
Almirall Investigational Sites#551
Almirall Investigational Sites#721
Almirall Investigational Sites#317
Almirall Investigational Sites#659
Almirall Investigational Sites#715
Almirall Investigational Sites#16
Almirall Investigational Sites#698
Almirall Investigational Sites#655
Almirall Investigational Sites#786
Almirall Investigational Sites#459
Almirall Investigational Sites#720
Almirall Investigational Sites#664
Almirall Investigational Sites#654
Almirall Investigational Sites#752
Almirall Investigational Sites#758
Almirall Investigational Sites#697
Almirall Investigational Sites#661
Almirall Investigational Sites#671
Almirall Investigational Sites#966
Almirall Investigational Sites#647
Almirall Investigational Sites#967
Almirall Investigational Sites#398
Almirall Investigational Sites#686
Almirall Investigational Sites#658
Almirall Investigational Sites#465
Almirall Investigational Sites#728
Almirall Investigational Sites#651
Almirall Investigational Sites#712
Almirall Investigational Sites#976
Almirall Investigational Sites#787
Almirall Investigational Sites#735
Almirall Investigational Sites#644
Almirall Investigational Sites#588
Almirall Investigational Sites#540
Almirall Investigational Sites#736
Almirall Investigational Sites#653
Almirall Investigational Sites#191
Almirall Investigational Sites#732
Almirall Investigational Sites#635
Almirall Investigational Sites#682
Almirall Investigational Sites#696
Almirall Investigational Sites#727
Almirall Investigational Sites#784
Almirall Investigational Sites#718
Almirall Investigational Sites#397
Almirall Investigational Sites#734
Almirall Investigational Sites#681
Almirall Investigational Sites#680
Almirall Investigational Sites#965
Almirall Investigational Sites#766
Almirall Investigational Sites#701
Almirall Investigational Sites#665
Almirall Investigational Sites#723
Almirall Investigational Sites#953
Almirall Investigational Sites#683
Almirall Investigational Sites#717
Almirall Investigational Sites#947
Almirall Investigational Sites#765
Almirall Investigational Sites#346
Almirall Investigational Sites#719
Almirall Investigational Sites#700
Almirall Investigational Sites#962


title: Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

acronym: CLARINET

summary: The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

ReferenceCitation: Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.

publisher_dissemination: S. Karger AG

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Germany
Italy
Poland
India
Slovakia
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
United States
Spain
Czechia
France

location_facility: Vychodoslovensky onkologicky ustav, Rastislavova

location_facility: Hospital Nuestra Senora de la Candelaria

location_facility: Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Basingstoke and North Hampshire Hospital

location_facility: Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego

location_facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie


title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

summary: This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.

ReferenceCitation: Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14.

ReferenceCitation: Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

ReferenceCitation: Buse JB, Peters A, Russell-Jones D, Furber S, Donsmark M, Han J, MacConell L, Maggs D, Diamant M. Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes Obes Metab. 2015 Feb;17(2):145-51. doi: 10.1111/dom.12402. Epub 2014 Nov 9.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Italy
Poland
Russian Federation
India
Slovakia
Norway
Argentina
Denmark
United Kingdom
Brazil
Netherlands
Austria
Spain
South Africa
Former Serbia and Montenegro
Philippines
France


type: Registry Identifier

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

acronym: FOURIER

summary: The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

ReferenceCitation: Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

ReferenceCitation: Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762. Erratum In: JAMA Cardiol. 2017 Oct 1;2(10):1170.

ReferenceCitation: Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.

ReferenceCitation: Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.

ReferenceCitation: Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.

ReferenceCitation: Fagundes A Jr, Morrow DA, Oyama K, Furtado RHM, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Keech AC, Sever P, Giugliano RP, Sabatine MS, Bergmark BA. Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial. J Am Coll Cardiol. 2022 Aug 30;80(9):887-897. doi: 10.1016/j.jacc.2022.05.051.

repository_institution: Imperial College London - Spiral

version: submittedVersion

ReferenceCitation: Furtado RHM, Fagundes AA Jr, Oyama K, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Mar;15(3):e011382. doi: 10.1161/CIRCINTERVENTIONS.121.011382. Epub 2022 Feb 25.

ReferenceCitation: Oyama K, Giugliano RP, Tang M, Bonaca MP, Saver JL, Murphy SA, Ruzza A, Keech AC, Sever PS, Sabatine MS, Bergmark BA. Effect of evolocumab on acute arterial events across all vascular territories : results from the FOURIER trial. Eur Heart J. 2021 Dec 14;42(47):4821-4829. doi: 10.1093/eurheartj/ehab604.

ReferenceCitation: Keech AC, Oyama K, Sever PS, Tang M, Murphy SA, Hirayama A, Lu C, Tay L, Deedwania PC, Siu CW, Lira Pineda A, Choi D, Charng MJ, Amerena J, Wan Ahmad WA, Chopra VK, Pedersen TR, Giugliano RP, Sabatine MS; FOURIER Study Group. Efficacy and Safety of Long-Term Evolocumab Use Among Asian Subjects - A Subgroup Analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) Trial. Circ J. 2021 Oct 25;85(11):2063-2070. doi: 10.1253/circj.CJ-20-1051. Epub 2021 May 15.

repository_institution: Deakin University - Deakin Research Online

repository_institution: Yonsei University Medical Library - YUHSpace

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

publisher_dissemination: Japanese Circulation Society

ReferenceCitation: Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

oa_host_type: repository

repositories_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repositories_institution: University College London - UCL Discovery

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

ReferenceCitation: Deedwania P, Murphy SA, Scheen A, Badariene J, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):139-147. doi: 10.1001/jamacardio.2020.3151.

ReferenceCitation: Gencer B, Mach F, Murphy SA, De Ferrari GM, Huber K, Lewis BS, Ferreira J, Kurtz CE, Wang H, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial. JAMA Cardiol. 2020 Aug 1;5(8):952-957. doi: 10.1001/jamacardio.2020.0882. Erratum In: JAMA Cardiol. 2021 Aug 1;6(8):980.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Bergmark BA, O'Donoghue ML, Murphy SA, Kuder JF, Ezhov MV, Ceska R, Gouni-Berthold I, Jensen HK, Tokgozoglu SL, Mach F, Huber K, Gaciong Z, Lewis BS, Schiele F, Jukema JW, Pedersen TR, Giugliano RP, Sabatine MS. An Exploratory Analysis of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition and Aortic Stenosis in the FOURIER Trial. JAMA Cardiol. 2020 Jun 1;5(6):709-713. doi: 10.1001/jamacardio.2020.0728.

ReferenceCitation: Wiviott SD, Giugliano RP, Morrow DA, De Ferrari GM, Lewis BS, Huber K, Kuder JF, Murphy SA, Forni DM, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS. Effect of Evolocumab on Type and Size of Subsequent Myocardial Infarction: A Prespecified Analysis of the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):787-793. doi: 10.1001/jamacardio.2020.0764.

ReferenceCitation: Giugliano RP, Pedersen TR, Saver JL, Sever PS, Keech AC, Bohula EA, Murphy SA, Wasserman SM, Honarpour N, Wang H, Lira Pineda A, Sabatine MS; FOURIER Investigators. Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis. Stroke. 2020 May;51(5):1546-1554. doi: 10.1161/STROKEAHA.119.027759. Epub 2020 Apr 21.

ReferenceCitation: Charytan DM, Sabatine MS, Pedersen TR, Im K, Park JG, Pineda AL, Wasserman SM, Deedwania P, Olsson AG, Sever PS, Keech AC, Giugliano RP; FOURIER Steering Committee and Investigators. Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial. J Am Coll Cardiol. 2019 Jun 18;73(23):2961-2970. doi: 10.1016/j.jacc.2019.03.513. Erratum In: J Am Coll Cardiol. 2019 Aug 27;74(8):1162-1166.

ReferenceCitation: Murphy SA, Pedersen TR, Gaciong ZA, Ceska R, Ezhov MV, Connolly DL, Jukema JW, Toth K, Tikkanen MJ, Im K, Wiviott SD, Kurtz CE, Honarpour N, Giugliano RP, Keech AC, Sever PS, Sabatine MS. Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial. JAMA Cardiol. 2019 Jul 1;4(7):613-619. doi: 10.1001/jamacardio.2019.0886.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: O'Donoghue ML, Fazio S, Giugliano RP, Stroes ESG, Kanevsky E, Gouni-Berthold I, Im K, Lira Pineda A, Wasserman SM, Ceska R, Ezhov MV, Jukema JW, Jensen HK, Tokgozoglu SL, Mach F, Huber K, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk. Circulation. 2019 Mar 19;139(12):1483-1492. doi: 10.1161/CIRCULATIONAHA.118.037184.

ReferenceCitation: Qamar A, Giugliano RP, Keech AC, Kuder JF, Murphy SA, Kurtz CE, Wasserman SM, Sever PS, Pedersen TR, Sabatine MS. Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data. JAMA Cardiol. 2019 Jan 1;4(1):59-63. doi: 10.1001/jamacardio.2018.4178.

ReferenceCitation: Martin SS, Giugliano RP, Murphy SA, Wasserman SM, Stein EA, Ceska R, Lopez-Miranda J, Georgiev B, Lorenzatti AJ, Tikkanen MJ, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Comparison of Low-Density Lipoprotein Cholesterol Assessment by Martin/Hopkins Estimation, Friedewald Estimation, and Preparative Ultracentrifugation: Insights From the FOURIER Trial. JAMA Cardiol. 2018 Aug 1;3(8):749-753. doi: 10.1001/jamacardio.2018.1533.

ReferenceCitation: Sabatine MS, De Ferrari GM, Giugliano RP, Huber K, Lewis BS, Ferreira J, Kuder JF, Murphy SA, Wiviott SD, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR. Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Disease: Analysis From FOURIER. Circulation. 2018 Aug 21;138(8):756-766. doi: 10.1161/CIRCULATIONAHA.118.034309.

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

ReferenceCitation: Bohula EA, Giugliano RP, Leiter LA, Verma S, Park JG, Sever PS, Lira Pineda A, Honarpour N, Wang H, Murphy SA, Keech A, Pedersen TR, Sabatine MS. Inflammatory and Cholesterol Risk in the FOURIER Trial. Circulation. 2018 Jul 10;138(2):131-140. doi: 10.1161/CIRCULATIONAHA.118.034032. Epub 2018 Mar 12.

ReferenceCitation: Bonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018 Jan 23;137(4):338-350. doi: 10.1161/CIRCULATIONAHA.117.032235. Epub 2017 Nov 13.

ReferenceCitation: Sabatine MS, Leiter LA, Wiviott SD, Giugliano RP, Deedwania P, De Ferrari GM, Murphy SA, Kuder JF, Gouni-Berthold I, Lewis BS, Handelsman Y, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Dec;5(12):941-950. doi: 10.1016/S2213-8587(17)30313-3. Epub 2017 Sep 15.

ReferenceCitation: Giugliano RP, Pedersen TR, Park JG, De Ferrari GM, Gaciong ZA, Ceska R, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Ott BR, Kanevsky E, Pineda AL, Somaratne R, Wasserman SM, Keech AC, Sever PS, Sabatine MS; FOURIER Investigators. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet. 2017 Oct 28;390(10106):1962-1971. doi: 10.1016/S0140-6736(17)32290-0. Epub 2017 Aug 28.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Iceland
Ukraine
India
Romania
Belgium
China
Malaysia
Estonia
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

summary: The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

enrollment_type: Anticipated

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

ReferenceCitation: Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.

sponsor_collaborators:
Bristol-Myers Squibb
Medarex

location_country:
France
Germany
Hungary
Australia
Brazil
Belgium
United States
South Africa
Canada
Czech Republic

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: Harry And Jeanette Weinberg Cancer Inst At Franklin Square

location_facility: The Angeles Clinic And Research Institution

location_facility: The Christ Hospital Cancer Center Research

location_facility: Washington University School Of Medicine


title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

summary: Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

lead_sponsor: Eisai Limited

location_country:
Germany
Italy
Lithuania
Poland
Portugal
Hungary
Israel
United Kingdom
Sweden
Austria
Belgium
Spain
South Africa
Serbia
Estonia
Czech Republic
France

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur

location_facility: Centre de Pharmacologie Clinique et Evaluation Therapeutique

location_facility: Universitatsklinik Lubeck Klinik fur Neurologie Ratzeburger Allee 160 D-23538 Lubeck

location_facility: Vilnius University Hospital, Santariskiu Clinic

location_facility: LMU Munchen, Neurologische Universitatsklinik

location_facility: Uni-klinikum Charite, Campus Virchow-klinikum

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Centre d'Investigation Clinique, Hospital Purpan


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks

summary: This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.

ReferenceCitation: Mohler ER 3rd, Ballantyne CM, Davidson MH, Hanefeld M, Ruilope LM, Johnson JL, Zalewski A; Darapladib Investigators. The effect of darapladib on plasma lipoprotein-associated phospholipase A2 activity and cardiovascular biomarkers in patients with stable coronary heart disease or coronary heart disease risk equivalent: the results of a multicenter, randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 2008 Apr 29;51(17):1632-41. doi: 10.1016/j.jacc.2007.11.079.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
India
New Zealand
Hungary
Argentina
Denmark
Australia
Estonia
Netherlands
Romania
United States
Spain
Pakistan
Bulgaria
Canada
France


title: Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

summary: The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

ReferenceCitation: Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.

sponsor_collaborators: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
India
Brazil
United States
South Africa
Croatia
Czechia
Bulgaria
Russian Federation
France

location_facility: Behavioral Medical Research Of Staten Island

location_facility: Psychopharmacology Research Network Of Torrance

location_facility: University Of Massachusetts Medical School

location_facility: University Of California, Irvine Medical Center


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

acronym: QUAZAR AML-001

summary:
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy.

The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.

ReferenceCitation: Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.

ReferenceCitation: Dohner H, Wei AH, Roboz GJ, Montesinos P, Thol FR, Ravandi F, Dombret H, Porkka K, Sandhu I, Skikne B, See WL, Ugidos M, Risueno A, Chan ET, Thakurta A, Beach CL, Lopes de Menezes D. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacitidine. Blood. 2022 Oct 13;140(15):1674-1685. doi: 10.1182/blood.2022016293.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Zhu J, Wu Q, Wang J, Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Expert Rev Hematol. 2022 Apr;15(4):375-382. doi: 10.1080/17474086.2022.2061456. Epub 2022 May 11.

publisher_dissemination: Informa

ReferenceCitation: Roboz GJ, Ravandi F, Wei AH, Dombret H, Thol F, Voso MT, Schuh AC, Porkka K, La Torre I, Skikne B, Zhong J, Beach CL, Risueno A, Menezes DL, Ossenkoppele G, Dohner H. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status. Blood. 2022 Apr 7;139(14):2145-2155. doi: 10.1182/blood.2021013404.

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Ravandi F, Roboz GJ, Wei AH, Dohner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Sussex - Sussex Research Online

ReferenceCitation: Wei AH, Dohner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Cakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Cermak J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.

repository_institution: Indiana University - IUScholarWorks

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

location_country:
Finland
Germany
Ireland
Poland
Australia
Brazil
Turkey
Czechia
Canada
France
Lithuania
Portugal
United States
Belgium
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: VA Commonwealth University - Massey Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: University of California San Francisco Fresno Campus

location_facility: University of Southern California Norris Cancer Center

location_facility: Norton Cancer Institute Louisville Oncology

location_facility: Cancer Care Centers of South Texas - Loop

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Providence St Joseph Medical Center Cancer Center

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: University Of Texas Southwestern Medical Center

location_facility: Columbia University Irving Medical Center

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: George Washington University Cancer Center

location_facility: Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL


title: A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.

acronym: ENESTPath

summary: This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

ReferenceCitation: Borghi L, Rosti G, Maggi A, Breccia M, Di Bona E, Iurlo A, La Barba G, Sportoletti P, Albano F, Galimberti S, Rivellini F, Cambrin GR, Capodanno I, Cuneo A, Bonifacio M, Sica S, Arcaini L, Capochiani E, Minotto C, Ciceri F, Crugnola M, Di Caprio L, Supekar S, Elena C, Baccarani M, Vegni E. Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy. Front Oncol. 2021 May 26;11:638689. doi: 10.3389/fonc.2021.638689. eCollection 2021.

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

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

publisher_dissemination: Frontiers

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Poland
Czechia
Serbia
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Romania
Belgium
Italy
Norway
United Kingdom
Austria
Spain
Greece
Bulgaria
Sweden


title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

acronym: OPTIMISMM

summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

ReferenceCitation: Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.

ReferenceCitation: Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2. Erratum In: Leukemia. 2018 Oct;32(10):2305.

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

repositories_concat: PubMed Central;dash.harvard.edu

location_country:
Finland
Germany
Ireland
Poland
Japan
Turkey
Canada
France
Portugal
Denmark
United States
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Russian Federation
Israel

location_facility: Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Alves Domenech Oncology and Hematology Clinic

location_facility: Huntsman Cancer Institute at the University of Utah

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

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: George Papanikolaou General Hospital of Thessaloniki

location_facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: University Hospital of North Staffordshire Nhs Trust - City General Hospital

location_facility: Worcestershire Acute Hospitals NHS Trust

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Klinika Hematoonkologii i Transplantacji Szpiku

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

location_facility: University of Tennessee Medical Center - Cancer Institute

location_facility: RSM Durham Regional Cancer Center - Lakeridge Health Oshawa

location_facility: A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC

location_facility: Hematology-Oncology Associates of NNJ, P

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit

location_facility: State Budgetary Healthcare Institution of Nizhniy Novgorod Region

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara

location_facility: USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: Centre De Sante Et De Services Sociaux De Rimouski-Neigette

location_facility: Henry Ford Medical Center - New Center One

location_facility: University of Athens Medical school - Regional General Hospital

location_facility: Wilhelminenspital-Center for Hematology and Oncology

location_facility: St. John's Clinic Cancerand Hematology - Springfield

location_facility: Universitaetsklinikum EssenInnere Klinik und Poliklinik

location_facility: Western Kentucky Hematology and Oncology Group, PSC

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Klinika Hematologii Akademii Medycznej w Gdansku

location_facility: Copenhagen University Hospital Rigshosptalet