title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

summary: This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

ReferenceCitation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gómez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Costa Rica
Peru
Belgium
Iceland
South Africa
Hong Kong
Portugal
Slovenia
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Panama
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Finland
Czech Republic
Thailand
France
Netherlands


ipd_sharing: Yes

status: Completed

primary_purpose: Prevention

acronym: OSAKA

intervention_type: Drug

title: A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)

study_completion_date_type: Actual

lead_sponsor: Astellas Pharma Inc

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: background

ReferenceCitation: Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd. Erratum in: Transplantation. 2014 Mar 27;97(6):38.

ReferenceType: derived

ReferenceCitation: Krämer BK, Albano L, Banas B, Charpentier B, Bäckman L, Tedesco-Silva H Jr, Lehner F, Mondragón-Ramírez GA, Glyda M, Cassuto-Viguier E, Viklický O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Romania
South Africa
Belgium
Czechia
Poland
Portugal
Austria
Russian Federation
Argentina
Norway
Sweden
Slovakia
Switzerland
Hungary
Germany
Greece
Ireland
France
Netherlands

summary: To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

lead_sponsor_type: industriel

status_simplified: Completed


title: FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens

acronym: FORTIS-M

summary: The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

primary_purpose: Treatment

lead_sponsor: Agennix

location_country:
Spain
Italy
United Kingdom
United States
Romania
Philippines
Poland
Russian Federation
Australia
India
Turkey
Malaysia
Singapore
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
Latvia
Czech Republic
Korea, Republic of
France

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Gerald Bronfman Centre for Clinical Research in Oncology

location_facility: Washington University School of Medicine

location_facility: University Hospital of North Staffordshire

location_facility: Chonnam National University Hwasun Hospital

location_facility: General Hospital of Chania 'Ag. Georgios'

location_facility: Cancer Care Specialists of Central Illinois

location_facility: Mahaveer Cancer Hospital and Research Centre

location_facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

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

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris"

location_facility: NCI, CCR, The Waren Grant Magnuson Clinical Center

location_facility: Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

location_facility: Specjalistyczny Szpital im. Prof. A. Sokolowskiego

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: CRO Centro di Riferimento Oncologico di Aviano

location_facility: Oncology Dispensary #2 of Krasnodar Region

location_facility: Istituto per la Ricerca e la Cura del Cancro

location_facility: University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital

location_facility: CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"

location_facility: John Hopkins Singapore International Medical Centre

location_facility: P. Stradina Clinical University Hospital

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"

location_facility: Praxis fuer interdisziplinaere Onkologie

location_facility: Gemeinschaftspraxis fuer Haematologie Onkologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Chang-Gung Memorial Hospital, Linkou Branch

location_facility: Nilai Cancer Institute (NCI Cancer Hospital)

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Akademickie Centrum Kliniczne - Szpital AM w Gdansku

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

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz

location_facility: Seoul National University Bundang Hospital

location_facility: Riga Eastern Clinical University Hospital

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Institut Onkologie a Rehabilitace Na Plesi

location_facility: Dr. Anna Levcenko GP and Internist Practice

location_facility: Deenanath Mangeshkar Hospital and Research Center

location_facility: Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi

location_facility: P.D. Hinduja Nat. Hospital & Med. Research Centre

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Kaushalya Medical Foundation Trust Hospital


title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Kubicka S, Greil R, André T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Müller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.

ReferenceCitation: Bennouna J, Sastre J, Arnold D, Österlund P, Greil R, Van Cutsem E, von Moos R, Viéitez JM, Bouché O, Borg C, Steffens CC, Alonso-Orduña V, Schlichting C, Reyes-Rivera I, Bendahmane B, André T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.

location_country:
Denmark
Portugal
Saudi Arabia
Spain
Austria
Estonia
Netherlands
Finland
Czech Republic
Switzerland
Sweden
France
Belgium
Norway
Germany

summary: This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.


type: Other Identifier

title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

acronym: TRILOGY ACS

summary: This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2:CD008834. doi: 10.1002/14651858.CD008834.pub4. Review.

ReferenceCitation: Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31.

ReferenceCitation: Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31.

ReferenceCitation: Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755.

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

ReferenceCitation: Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17.

ReferenceCitation: Goldstein SA, Newby LK, Cyr DD, Neely M, Lüscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4). pii: e005334. doi: 10.1161/JAHA.116.005334.

ReferenceCitation: Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5.

ReferenceCitation: Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11). pii: e003977.

ReferenceCitation: Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalán R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30.

ReferenceCitation: Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034.

ReferenceCitation: Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036.

ReferenceCitation: Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalán R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16.

ReferenceCitation: Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5.

ReferenceCitation: Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20.

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

ReferenceCitation: Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23.

ReferenceCitation: Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10.

ReferenceCitation: Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24. Erratum in: Am Heart J. 2014 Oct;168(4):605.

ReferenceCitation: Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8. Erratum in: Lancet. 2013 Aug 31;382(9894):768.

ReferenceCitation: Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312.

ReferenceCitation: Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteză M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25.

ReferenceCitation: Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12. Review.

ReferenceCitation: Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022.

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Costa Rica
Peru
Belgium
Philippines
Romania
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Tunisia
Puerto Rico
India
Israel
Malta
Panama
Mexico
Turkey
Malaysia
Singapore
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

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


acronym: FIRST

title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.

lead_sponsor: Celgene

ReferenceCitation: Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.

ReferenceCitation: Hulin C, Belch A, Shustik C, Petrucci MT, Dührsen U, Lu J, Song K, Rodon P, Pégourié B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.

ReferenceCitation: Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.

ReferenceCitation: Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.

ReferenceCitation: Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.

ReferenceCitation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathé Y, Facon T. A predictive model for risk of early grade ≥ 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

ReferenceCitation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

ReferenceCitation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

ReferenceCitation: Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.

ReferenceCitation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

ReferenceCitation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

ReferenceType: result

ReferenceCitation: Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.

ReferenceCitation: Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.

location_country:
Taiwan
Portugal
Spain
Greece
Austria
Australia
Ireland
Canada
Italy
New Zealand
Switzerland
Sweden
Korea, Republic of
United States
France
China
United Kingdom
Belgium
Germany

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

location_facility: Abteilung Onkologie Haematologie des Kantonsspitals Aarau

location_facility: Maine Center for Cancer Medicine Blood Disorders

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: CHUQ - Hotel-Dieu de QuebecHematology - Oncology

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Belfast City Hospital Haematology Department

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Clinique Pont de chaume Oncologie et Radiotherapie

location_facility: Alexandra Hospital, University of Athens

location_facility: Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: Hwasun Chonnam National University Hospital

location_facility: A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia

location_facility: Hospital of the Barmherzigen Bruder Vienna

location_facility: Oncologia Medica, Università della Magna Grecia

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: University of California, San Francisco- California

location_facility: Medizinische Fakultat der Universitat Rostock

location_facility: Daegu Catholic University Medical Center 3056-6

location_facility: Unità Operativa di Oncoematologia, Ospedale di Matera

location_facility: Casa di Cura La Maddalena, Divisione di Ematologia

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

location_facility: Cedar Sinai Medical Center Dept of Medicine

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: West China Hospital of Sichuan University

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology

location_facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat

location_facility: Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali

location_facility: Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie

location_facility: MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III

location_facility: University of Tennessee Cancer Institute

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Staedtische Kliniken Frankfurt am Main Hochst

location_facility: U.O. di Ematologia e Trapianto di Midollo Osseo

location_facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Dept of Haematology St Bartholomews Hospital

summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.


title: Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus

acronym: PANDORA

summary: Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Sanna G, Alesso D, Mediati M, Cimminiello C, Borghi C, Fazzari AL, Mangrella M; PANDORA study investigators. Prevalence of peripheral arterial disease in subjects with moderate cardiovascular risk: Italian results from the PANDORA study Data from PANDORA (Prevalence of peripheral Arterial disease in subjects with moderate CVD risk, with No overt vascular Diseases nor Diabetes mellitus). BMC Cardiovasc Disord. 2011 Oct 7;11:59. doi: 10.1186/1471-2261-11-59.

ReferenceCitation: Cimminiello C, Borghi C, Kownator S, Wautrecht JC, Carvounis CP, Kranendonk SE, Kindler B, Mangrella M; PANDORA Study Investigators. Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study. BMC Cardiovasc Disord. 2010 Aug 5;10:35. doi: 10.1186/1471-2261-10-35.

lead_sponsor: AstraZeneca

location_country: Italy Greece Switzerland France Belgium Netherlands


title: An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman

acronym: CARIATIDE

summary: This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

time_perspective: Prospective

enrollment_type: Anticipated

location_country:
Croatia
Belgium
Romania
United Kingdom
Greece
Austria
Australia
Italy
Finland
Czech Republic
Switzerland
Venezuela
France
Chile
Peru
Turkey
Colombia
Sweden


title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

acronym: VOLT

summary: The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Spain
Greece
Italy
Australia
Netherlands
Canada
Czech Republic
United Kingdom
Sweden
France
Belgium
Norway
Germany
Slovakia


status: Terminated

title: A Phase Iii, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy And Safety Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Carriers

lead_sponsor: Pfizer

ReferenceCitation: Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.

ReferenceCitation: Lacey L, Bobula J, Rüdell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Japan
Poland
Portugal
Austria
Australia
Argentina
Mexico
Sweden
Slovakia
Switzerland
Germany
New Zealand
Finland
France
Chile
Netherlands

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: Psychiatricka nemocnica Michalovce, n.o.

location_facility: MAC UK Neuroscience, Research Assessment Centre

location_facility: Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy

location_facility: Unita' Operativa C - Riabilitazione Neurologica

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: Kansai Medical University Takii Hospital

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: Medical University of South Carolina Hospitals and Clinics

location_facility: Fundacio ACE Institut Catala de Neurociences Aplicades

location_facility: IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: UPENN Clinical and Transitional Research Center

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Ohio State University Imaging@Martha Moorehouse

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Instituto Biomedico de Investigacion A.C

location_facility: Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i

location_facility: Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Carolina Neuropsychological Services, Inc

location_facility: Southern Illinois University School of Medicine Department

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: Sezione di Neurologia - Dipartimento di Neuroscienze

location_facility: Wm S. Middleton Memorial Veterans Hospital

location_facility: Kobe City Hospital Org Kobe City Medical Cente West Hp

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika

location_facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: UAB Clinical Research Pharmacy-Russell Clinic

location_facility: The Center for Pharmaceutical Research P.C.

location_facility: University of Pennsylvania-Penn Memory Center

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: University of Michigan Hospital and Health System

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: National Hospital Organization Kokura Medical Center

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Unita' Operativa Complessa di Neurologia

location_facility: CeSI (Centro di Scienze dell'invecchiamento) -

location_facility: Centro Internacional de Medicina Avanzda (CIMA)

location_facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Centre d'Imagerie medicale de Basse Normandie

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Institute for Cardiovascular Diseases of Vojvodina

location_facility: Rhode Island Mood and Memory Research Institute

location_facility: Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,

location_facility: McCusker Alzheimer's Research Foundation, Inc.

location_facility: Participant and Clinical Interactions Resources

location_facility: National Hospital Organization Maizuru Medical Center

location_facility: Alzheimer's Research Corp./Merician Institute for Aging

location_facility: Dept. of Neurosciences Charing Cross Hospital

location_facility: Clinical Centre Kragujevac, Clinic of Psichiatry

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: General Clincial Research Center (Infusion Location)

location_facility: National Hospital Organization Niigata National Hospital

summary: This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

status_simplified: Unknown


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Poland
Portugal
Russian Federation
Australia
Argentina
Mexico
Sweden
Slovakia
Canada
Switzerland
Germany
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: McCusker Alzheimer's Research Foundation Inc.

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: Seoul National University Bundang Hospital, Department of Psychiatry

location_facility: Psychiatricka nemocnica Michalovce, n.o.

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy

location_facility: Unita' Operativa C - Riabilitazione Neurologica

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: University of Virginia General Clinical Research Center

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko

location_facility: Southern Illinois University School of Medicine

location_facility: Kansai Medical University Takii Hospital

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: The Ohio State University Hospitals Clinic

location_facility: Medical University of South Carolina Hospitals and Clinics

location_facility: Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych

location_facility: UPENN Clinical and Translational Research Center (CTRC)

location_facility: Klinik fur Psychiatrie und Psychotherapie

location_facility: Institutional Review Board / Ethics Committee

location_facility: The clinic: Minnes- och geriatrikmottagningen

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: Methodist Medical Center Research Department

location_facility: KonKuk University Hospital, Department of NeuroPsychiatry

location_facility: Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

location_facility: Medical Research and Health Education Foundation, Incorporated

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine

location_facility: Memory Enhancement Center of America, Inc.

location_facility: University of Rochester/Strong Memorial Hospital

location_facility: Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

location_facility: Medical University of South Carolina Investigational Drug Service

location_facility: Instituto Biomedico de Investigacion A.C

location_facility: Clinical Trials of America, Incorporated

location_facility: Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

location_facility: Memory Enhancement Center of New Jersey, Inc.

location_facility: Institute for Neurodegenerative Disorders

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Saint-Petersburg State institution of healthcare, City geriatric medico-social center

location_facility: Fundació ACE Institut Catala de Neurociences Aplicades

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: Investigational New Drug Services, IDS Pharmacy

location_facility: Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit

location_facility: University of Viriginia Investigational Pharmacy

location_facility: Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca

location_facility: Kobe City Hospital Org Kobe City Medical Cente West Hp

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika

location_facility: University of North Texas Health Science Center

location_facility: Hospital of the University of Pennslyvania

location_facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: Research Center for Clinical Studies, Inc.

location_facility: The Ohio State University Medical Center

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Four Rivers Clinical Research, Incorporated

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: Carolina Neuropsychological Services, Inc.

location_facility: National Hospital Organization Kokura Medical Center

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Unita' Operativa Complessa di Neurologia

location_facility: CeSI (Centro di Scienze dell'invecchiamento) -

location_facility: Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: Nippon Medical School Musashikosugi Hospital

location_facility: Ohio State University Imaging at Martha Morehouse

location_facility: Hospital of the University of Pennsylvania (PET)

location_facility: Alexian Brothers Neurosciences Institute

location_facility: AD-CARE, University of Rochester Medical Center


title: A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

summary: This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

ReferenceCitation: Schwartz GG, Leiter LA, Ballantyne CM, Barter PJ, Black DM, Kallend D, Laghrissi-Thode F, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Preiss D, Shah PK, Tardif JC, Kittelson J. Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease. Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6.

ReferenceCitation: Salahuddin T, Kittelson J, Tardif JC, Shah PK, Olsson AG, Nicholls SJ, Leitersdorf E, Leiter LA, Kallend D, Black DM, Barter PJ, Ballantyne CM, Schwartz GG. Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial. Am Heart J. 2020 Mar;221:60-66. doi: 10.1016/j.ahj.2019.12.003. Epub 2019 Dec 16.

ReferenceCitation: Schwartz GG, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Shah PK, Tardif JC, Kittelson J. Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):164-168. doi: 10.1001/jamacardio.2017.3833.

ReferenceCitation: Pitts R, Gunzburger E, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, Nicholls SJ, Shah PK, Tardif JC, Olsson AG, McMurray JJ, Kittelson J, Schwartz GG. Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure. J Am Heart Assoc. 2017 Jan 10;6(1). pii: e004119. doi: 10.1161/JAHA.116.004119.

ReferenceCitation: Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boulé M, Alem S, Grégoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rhéaume E, Dubé MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.

ReferenceCitation: Schwartz GG, Abt M, Bao W, DeMicco D, Kallend D, Miller M, Mundl H, Olsson AG. Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol. 2015 Jun 2;65(21):2267-75. doi: 10.1016/j.jacc.2015.03.544. Erratum in: J Am Coll Cardiol. 2015 Jul 21;66(3):334.

ReferenceCitation: Tardif JC, Rhéaume E, Lemieux Perreault LP, Grégoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dubé MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.

ReferenceCitation: Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS; dal-OUTCOMES Investigators. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5.

ReferenceCitation: Lüscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Münzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

ReferenceCitation: Derks M, Abt M, Parr G, Meneses-Lorente G, Young AM, Phelan M. No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opin Investig Drugs. 2010 Oct;19(10):1135-45. doi: 10.1517/13543784.2010.509342.

ReferenceCitation: Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J; dal-OUTCOMES Committees and Investigators. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017.

ReferenceCitation: Stein EA, Stroes ES, Steiner G, Buckley BM, Capponi AM, Burgess T, Niesor EJ, Kallend D, Kastelein JJ. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 Jul 1;104(1):82-91. doi: 10.1016/j.amjcard.2009.02.061.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Poland
Austria
Australia
Argentina
Puerto Rico
Israel
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Ireland
New Zealand
Finland
Korea, Republic of
France
Grenada
Netherlands


acronym: EXPECT

title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

ReferenceCitation: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.

location_country:
Australia
United States
France
Belgium

location_facility: Cliniques universitaires UCL de Mont-Godinne

location_facility: Box Hill Hospital, 4th Floor, Clive Ward Centre

location_facility: Clinical Research Unit Cairns Base Hospital

summary:
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.


title: Spontaneous Atrio Ventricular Conduction Preservation

acronym: SAVER

summary:
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.

In addition to saving energy, the latter mode allows spontaneous ventricular activation, the haemodynamic consequences of which are, in most cases, better than those obtained with dual chamber pacing.

Recent studies as the MOST study suggest also that ventricular desynchronization imposed by right ventricular apical pacing even when AV synchrony is preserved increases the risk of atrial fibrillation in patients with SND. Similar results were already given by anterior studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested that AF prevention algorithm in combination with a preserved native conduction are efficient in reducing AF burden.

However, current practice is to implant a dual chamber pacemaker to prevent the risk of atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found inefficient in reducing ventricular pacing and was associated with a high risk of arrhythmias.

The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, irrespective of whether or not these are accompanied by an atrial arrhythmia, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2 particular modes are called the AAI SafeR and DDD/AMC (R) mode.

The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay after a sensed or paced atrial event which allows long PR intervals or even limited ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV Delay after switching to DDD(R) according to measured spontaneous conduction times and to provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been assessed in clinical studies.

This study intends to demonstrate that the automatic modes switching significantly reduce the percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to standard DDD pacing with long AVDelay.

lead_sponsor: LivaNova

location_country:
United Kingdom
Italy
France
Belgium
Germany

location_facility:
Bristol Royal Infirmary
Universitätskliniken Bonn
Klinikum Lüdenscheid
Centre Hospitalier
KH Holweide
Herzzentrum Kassel
Praxis Bitar
CHU Pontchaillou
Ospedale Civili Reuniti
Clinique Bizet
Univ. Mainz
Ospedale S. G. Battista
Barts and The London NHS Trust
Waren-Müritzklinikum
InParys Cardiology
Clinique Louis Caty
St. Salvator Krankenhaus Halberstadt
Holzminden Praxis Bub
St Thomas' Hospital,
Hospice St-Jacques-Hôspital G.Montpied
Univ. Marburg
Leeds General Infirmary
Onze lieve Vrouw ziekenhuis
Klinikum Bogenhausen
St.Josef-Stift Bremen
Uni Regensburg
Castle Hill Hospital
Istituto Policlinico
Hürth Sana
Heiling Hart van Jezus
Augustinum
CH de CASTRES
CH Emile Muller
CHU de Nice
Ospedale Moscati
CHU - Tivoli
Klinkum Memmingen
Uni Ulm
Ospedale Mellini
Universitätsklinikum Schleswig-Holstein
Queens Hospital
Queen Elizabeth Hospital
Städt. Kh. Lüneburg
CHRU de Lille - Hôpital Cardiologique
CH Montpellier
Marien Hospital
Ospedale Civile
Ospedale Umberto I
CHU Jean Minjoz
CHU de Nantes
CHU - Hopital Michallon
CH Albi
CHU d'Angers
Nouvelles Cliniques Nantaises
Rot-Kreuz Krankenhaus
Prof. Frey Praxis Starnberg
Europa ziekenhuis
Hôpital Vésale (univ.)
Klinikum Wolgast
CHU de Limoges
CHU Hopital C. Nicolle
Hôpital universitaire Brugmann
CHU de Nancy

intervention_type: Device


title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16. Review.

ReferenceCitation: Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22. Erratum in: Adv Ther. 2021 Aug;38(8):4596-4597.

ReferenceCitation: Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.

ReferenceCitation: Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12). pii: e002340. doi: 10.1161/JAHA.115.002340.

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Norway
Malaysia
Singapore
Brazil
Canada
Hungary
China
Germany
Denmark
Czech Republic
Korea, Republic of
France
Chile

location_facility: University Of Arkansas For Medical Sciences

location_facility: Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Washington University School Of Medicine

location_facility: Internal Medical Associates Of Grand Island, P.C

location_facility: University Of California San Francisco-Fresno

location_facility: University Of California, Davis Medical Center

location_facility: George Washington University Medical Faculty Associates

location_facility: Chest Medicine & Critical Care Medical Gr. Inc.


acronym: TavIx

title: Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.

lead_sponsor: UNICANCER

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_country:
United States
France
Belgium

location_facility: CCOP - Geisinger Clinic and Medical Center

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies

location_facility: Roger Maris Cancer Center at MeritCare Hospital

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Green Bay Oncology, Limited at St. Mary's Hospital

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Oncology Associates at Rapid City Regional Hospital

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: CCOP - Missouri Valley Cancer Consortium

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.


title: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

acronym: ENTHUSE M0

summary:
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.

Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Latvia
Finland
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands


acronym: BETH

title: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

lead_sponsor: NSABP Foundation Inc

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Sweden
Egypt
Bosnia and Herzegovina
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Estonia
Latvia
Thailand
Korea, Republic of
France
Chile

location_facility: The Center for Cancer and Blood Disorders

location_facility: Irmandade da Santa Casa de Misericoria de Porto Alegre Nucleo de Novos Tratamentos

location_facility: Henry Ford Medical Center-West Bloomfield

location_facility: Connecticut Multi Specialty Group-Hartford

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: North County Oncology Medical Clinic, Inc.

location_facility: CCOP, Christiana Care Health Services Inc.

location_facility: NY Oncology Hematology PC at Albany Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Das Clinicas de Porto Alegre-HCPA

location_facility: The Lady Davis Carmel Medical Center/Lynn

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: UPMC Cancer Centers Arnold Palmer-Mt. Pleasant

location_facility: University Medical Center of Southern Nevada

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Fachärzte fürlnnere Medizin, Hämatologie

location_facility: Eastern Connecticut Hematology & Oncology Associates

location_facility: Landeskrankenhaus Leoben, Abteilung fur Haemato-Onkologie

location_facility: Northern Arizona Hematology & Onclogy Associates

location_facility: Dayton Clinical Oncology Program-Kettering

location_facility: MBCCOP, John H. Stroger, JR., Hospital of Cook County-Chicago

location_facility: Upper Peninsula Hematology/Oncology Associates

location_facility: Washington Oncology-Hematology Center, PC-Chevy Chase

location_facility: UP Hematology/Oncology Assoc.-Doctor's Park Family Physicians

location_facility: Berdat Family Comprehensive Cancer Centre

location_facility: University Hospital and Medical Center - SUNY

location_facility: Fuzhou General Hospital of Nanjing Military Area

location_facility: Florida Cancer Specialists-Port Charlotte

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Oncology/Hematology Care Clinical Trials LLC, Cincinnati, OH Blue Ash Med. Cntr. (Administrative Only)

location_facility: Cancer and Blood Specialists- Shadow Lane

location_facility: Hubert H. Humphrey Cancer Center-Robbinsdale

location_facility: Carolinas Medical Center - Blumenthal Cancer Center

location_facility: Northwestern Carolina Oncology & Hematology, PA

location_facility: Oncology Associates of Bridgeport-Trumbull

location_facility: Florida Cancer Specialists-Bonita Springs

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Peninsula Regional Oncology & Hematology

location_facility: Seoul National University Bundang Hospital

location_facility: (Azienda u.s.I. chieti) - Policinico Ospedaliero

location_facility: Central Hematology/Oncology Medical Group, Inc.

location_facility: Santa Barbara Hematology Oncology Medical Group

location_facility: Oncology Associates of Bridgeport-Fairfield

location_facility: Tartu University Hospital Clinic of Hematology and Oncology

location_facility: Riverview Cancer Care Medical Association

location_facility: Michiana Hematology-Oncology, P.C. Cedar St.

location_facility: Hematology and Medical Oncology Consultants-Bettendorf

location_facility: Hubert H. Humphrey Cancer Center - Fridley

location_facility: Medizinische Universitat Graz - Onkologie

location_facility: Comprehensive Cancer Centers of Nevada (Siena)

location_facility: Zentrum fur Frauenheilkunde und Geburtshilfe

location_facility: Mecklenburg Medical Group - Cameron Valley Pkwy

location_facility: Federal State Institution "Research Institute of Oncology n.a. N.N. Petrov Rosmedtechnologiy"

location_facility: Carolinas Hematology-Oncology - John J. Delaney

location_facility: Centro Integral de Oncologia "Clara Campal"

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

location_facility: UPMC Cancer Centers-John P. Murtha Cancer Center

location_facility: Saint-Petersburg State Medical Institution "City Clinical Oncology Dispensary"

location_facility: Mecklenburg Medical Group - Morehead Medical Dr

location_facility: Hubert H. Humphrey Cancer Center - Coon Rapids

location_facility: Adelaide and Meath National Childrens Hospital

location_facility: Medizinische Universitaet Wien-Allgemeines Krankenhaus, Onkologie

location_facility: Central Coast Medical Oncology Corporation

location_facility: Krankenhaus Hietzing, Gynaekologische Abteilung

location_facility: Michiana Hematology-Oncology, P.C. (Main Office)

location_facility: Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement

location_facility: Centro de Oncologia e Hematologia da Faculdade de Medicina do ABC

location_facility: Cancer Institute of New Jersey at Hamilton

location_facility: North Treatment Center - Blue Ash Medical Center

location_facility: Florida Cancer Specialists-Venice Island

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: San Diego Pacific Oncology & Hematology-Vista

location_facility: NY Oncology Hematology PC- Latham- Capital District Oncology Hematology

location_facility: Thompson Cancer Survival Center-Dowell Springs

location_facility: Carolinas Hematology-Oncology Associates - Tyron St

location_facility: Ephrata Cancer Center at Ephrata Community Hospital

location_facility: Michigan State University - Breslin Cancer Center

location_facility: UPMC Cancer Centers Arnold Palmer Pavilion-Mountainview

location_facility: Krankenhaus Barmherzige Brueder Graz, Medizinische Abteilung

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Cross Cancer Institute, Dept of Medicine

location_facility: CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only)

location_facility: Klinikum Wels-Grieskirchen, Kooperative Gruppe Wels/4. Medizinische Abteilung

location_facility: Centre Regional de Lutte contre le Cancer (CRLC) Val d'Aurelle

location_facility: St. John's Regional Health Center-Joplin

location_facility: Hematology/Oncology Associates of OH and MI, PC

location_facility: Krankenhaus Barmherzige Schwestern Linz, Kooperative Studiengruppe, Chirurgie

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Hematology Oncology Associates of CNY, CCOP

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: AI Universitätsklinikum der PMU Landeskliniken

location_facility: Florida Cancer Specialists-Fort Myers Summerlin

location_facility: Dayton Physicians-LLC-Hematology & Medical Oncology Division

location_facility: Washington Oncology-Hematology Center, PC-Washington

location_facility: UPMC Cancer Centers - McKeesport Hospital

location_facility: NY Oncology Hematology PC-Hudson Carvell Cancer Tx Prog.

location_facility: Department of Oncotherapy National Hospital

location_facility: Covenant Health System dba Joe Arrington Cancer Research & Treatment Center

location_facility: Florida Cancer Specialists-Naples Goodlette

location_facility: Florida Cancer Specialists-Cape Coral Del Prado

location_facility: UPMC Cancer Centers Arnold Palmer-Oakbrook

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik"

location_facility: Florida Cancer Specialists-Fort Myers Broadway

location_facility: University Hospital and Medical Center-SUNY

location_facility: Hematology Oncology Assaociates of CNY, CCOP

location_facility: Michiana Hematology-Oncology, P.C. (Elkhart)

location_facility: State Medical Institution "Republican Clinical Oncology Dispensary Ministry of Health of Republic Tatarstan"

location_facility: Northwest Cancer Specialists-Adventist Office

location_facility: Klinikverbund Suedwest - Sindelfingen-Böeblingen Clinical Centre

location_facility: Bezirkskrankenhaus Kufstein, Innere Medizin

location_facility: Carolinas Hematology Oncology Associates - Harris Blvd.

location_facility: Berkshire Hematology Oncology, P.C.-North Adams

location_facility: 1st Affiliated Hospital of Zhejiang University

location_facility: Kaposi Mor oktato korhaz Onkologiai tanszek

location_facility: Cancer Care Specialists-Central Illinois

location_facility: MBCCOP, Virginia Commonwealth University

location_facility: UP Hematology/Oncology Associates-Gogebic Range

location_facility: P.G. Hospital of Thessaloniki "Papageorgiou"

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Community Cancer Care Specialists-Mt. Clemens

location_facility: Rockwood Cancer Treatment Center - Sinto Ave

location_facility: IRCCS - Instituto Nazionale per lo Studio e la Cura

location_facility: Michiana Hematology-Oncology, PC Lakeland

location_facility: Landeskrankenhaus Voecklabruck, 2. Medizinische Abteilung

location_facility: Hematology and Medical Oncology Consultants-Davenport

location_facility: P. Stradina Clinical University Hospital

location_facility: Minnesota Oncology Hematology PA - Maplewood

location_facility: Florida Cancer Specialists-Cape Coral Parkway

location_facility: Connecticut Multi Specialty Group-Wethersfield

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: State Institution "Russian Oncological Research Center n.a. N.N. Blokhin of RAMS"

location_facility: Allegheny General Hospital/Allegheny-Singer Research Institute

location_facility: Praxis und Tagesklinik fuer Onkologie und

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Suburban Hematology Oncology Associates PC

location_facility: Hematology Oncology Assoc. of CNY, CCOP (Comm. General Hospital Satellite Office)

location_facility: CCOP, St. John Hospital and Medical Center

location_facility: Oncology/Hematology Care Clinical Trials LLC

location_facility: Drs. Forte, Schleider, Attas and Condemi, PA

location_facility: Harry & Jeannette Weinberg Cancer Institute

location_facility: Providence Oncology and Hematology Care Clinic

location_facility: University of Tennessee Cancer Institute

location_facility: Michiana Hematology-Oncology, P.C. (LaPorte)

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: Instituto de Oncologia Clinica de Piracicaba

location_facility: Case Western Reserve/University Hospitals-Ireland Cancer Cntr.

summary: The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.


title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA₁c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.

ReferenceCitation: Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.

ReferenceCitation: Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

location_country:
Denmark
Poland
Hong Kong
United Kingdom
Ireland
Italy
Netherlands
Sweden
Hungary
United States
France
India
South Africa
Norway
Germany
Bulgaria

location_facility: 1218.20.39030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35203 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39027 Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.3301A Boehringer Ingelheim Investigational Site

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control