title: A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pretreatment At the Time of Diagnosis in Patients With Non-ST-Elevation Myocardial Infarction (NSTEMI): The ACCOAST Study

acronym: ACCOAST

summary: The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

ReferenceCitation: Silvain J, Rakowski T, Lattuca B, Liu Z, Bolognese L, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Miller D, Portal JJ, Collet JP, Vicaut E, Montalescot G, Dudek D; ACCOAST Investigators. Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Mar 5;73(8):906-914. doi: 10.1016/j.jacc.2018.11.055.

ReferenceCitation: Porto I, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimský P, Le Gall N, Zagar AJ, LeNarz LA, Miller D, Montalescot G; ACCOAST Investigators. Impact of Access Site on Bleeding and Ischemic Events in Patients With Non-ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy. JACC Cardiovasc Interv. 2016 May 9;9(9):897-907. doi: 10.1016/j.jcin.2016.01.041.

ReferenceCitation: Dudek D, Dziewierz A, Widimsky P, Bolognese L, Goldstein P, Hamm C, Tanguay JF, LeNarz L, Miller DL, Brown E, Ten Berg J, Montalescot G; ACCOAST Investigators. Impact of prasugrel pretreatment and timing of coronary artery bypass grafting on clinical outcomes of patients with non-ST-segment elevation myocardial infarction: From the A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST-Elevation Myocardial Infarction (ACCOAST) study. Am Heart J. 2015 Nov;170(5):1025-1032.e2. doi: 10.1016/j.ahj.2015.07.017. Epub 2015 Jul 26.

ReferenceCitation: Widimsky P, Motovska Z, Bolognese L, Dudek D, Hamm C, Tanguay JF, Ten Berg J, Brown E, LeNarz L, Miller DL, Montalescot G; ACCOAST Investigators. Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel. Heart. 2015 Aug;101(15):1219-24. doi: 10.1136/heartjnl-2015-307686. Epub 2015 Jun 9.

ReferenceCitation: Montalescot G, Collet JP, Ecollan P, Bolognese L, Ten Berg J, Dudek D, Hamm C, Widimsky P, Tanguay JF, Goldstein P, Brown E, Miller DL, LeNarz L, Vicaut E; ACCOAST Investigators. Effect of prasugrel pre-treatment strategy in patients undergoing percutaneous coronary intervention for NSTEMI: the ACCOAST-PCI study. J Am Coll Cardiol. 2014 Dec 23;64(24):2563-2571. doi: 10.1016/j.jacc.2014.08.053.

ReferenceCitation: Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.

ReferenceCitation: Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg J, Widimsky P, Luo J, Miller DL, Goedicke J. A comparison of prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis in patients with non-ST-segment elevation myocardial infarction: design and rationale for the ACCOAST study. Am Heart J. 2011 Apr;161(4):650-656.e1. doi: 10.1016/j.ahj.2010.10.017. Epub 2011 Feb 25.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Portugal
Romania
Italy
Austria
Latvia
Netherlands
Finland
Canada
Czech Republic
Lithuania
Sweden
Hungary
France
Israel
Turkey
Belgium
Germany
Slovakia

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.


type: Other Identifier

type: EudraCT Number

title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

acronym: monarcHER

summary: The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, André F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27. Erratum in: Lancet Oncol. 2021 Mar;22(3):e92. Lancet Oncol. 2021 Nov;22(11):e472.

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Brazil
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
United Kingdom
Korea, Republic of
United States
France
Belgium
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: North Shore Hematology Oncology Associates

location_facility: Instituto COI de Pesquisa Educação e Gestão

location_facility: Central Coast Medical Oncology Corporation

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: Universitair Ziekenhuis Leuven - Gasthuisberg

location_facility: Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

location_facility: TRIO - Translational Research in Oncology-US, Inc.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

ReferenceCitation: Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
Switzerland
United Kingdom
Sweden
United States
France
Israel
Norway
Belgium
Japan
Germany

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: Erlanger Oncology & Hematology - Univ. of TN

intervention_type: Radiation


status: Completed

title: 12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

lead_sponsor: Boehringer Ingelheim

source: euctr

ReferenceCitation: Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. Epub 2012 Aug 13.

location_country:
Spain
Italy
Netherlands
Canada
Korea, Republic of
India
France
Belgium
Malaysia

location_facility: 1218.62.39007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11012 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39011 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302I Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305F Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39010 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11011 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302G Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11014 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39012 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11013 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305I Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39009 Boehringer Ingelheim Investigational Site

summary: The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

status_simplified: Completed


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

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

study_completion_date_type: Actual

ReferenceCitation: Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Döhner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

ReferenceCitation: Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Döhner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.

lead_sponsor: Hoffmann-La Roche

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


title: A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

acronym: SOLID-TIMI 52

summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

ReferenceCitation: Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077.

ReferenceCitation: Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10). pii: e006959. doi: 10.1161/JAHA.117.006959.

ReferenceCitation: Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1). pii: e004332. doi: 10.1161/JAHA.116.004332.

ReferenceCitation: O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators, Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061. Erratum in: JAMA. 2014 Oct 8;312(14):1473. Dylan P. Steen[corrected to Dylan L. Steen].

ReferenceCitation: O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
India
Israel
Turkey
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

intervention_type: Other


status: Terminated

title: A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.

lead_sponsor: Pfizer

design_allocation: Non-Randomized

ReferenceCitation: Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

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

location_facility: Llandough Hospital, Universtity Hospital of Wales

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

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

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

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: Centre Hospitalier Universitaire Charles Nicolle

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: Bendheim Infusion Center, Greenwich Hospital

location_facility: Banner Good Samaritan Medical Center (Imaging

location_facility: Fundacio ACE Institut Catala de Neurociences Aplicades

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou

location_facility: Center for Healthy Aging, Greenwich Hospital

location_facility: Providence Brain Institute-Cognitive Assessment Clinic

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Southern Illinois University School of Medicine Department

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: Sezione di Neurologia - Dipartimento di Neuroscienze

location_facility: Memory Service North, Grenoside Grange Hospital

location_facility: Palm Beach Neurological Center, Advanced Research Consultants, Inc.

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: Neurological Research Center of Hattiesburg Clinic

location_facility: Research Center for Clinical Studies, Inc.

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

location_facility: Carolina Neuropsychological Services, Inc.

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: The McCusker Foundation for Alzheimer's Disease Research

location_facility: Alexian Brothers Neurosciences Institute Clinical Research

location_facility: Rhode Island Mood and Memory Research Institute

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: The Center for Pharmaceutical Research, P.C.

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: National Hospital Organization Niigata National Hospital

summary: The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

status_simplified: Unknown


title: A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

summary: A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
Hungary
United States
France
Israel
Belgium
Germany

location_facility: University of Texas Health Science Center at Houston

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Clinical Research of West Florida - Corporate

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Pavlov First Saint Petersburg State Medical University


title: A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE

acronym: RE-EMBARK

summary: The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

ReferenceCitation: Van den Bosch F, Wei JC, Nash P, Blanco FJ, Graham D, Zang C, Arthur E, Borlenghi C, Tsekouras V, Vlahos B, Deodhar A. Etanercept Withdrawal and Re-Treatment in Non-Radiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label, Phase IV Trial. J Rheumatol. 2022 Nov 15. pii: jrheum.220353. doi: 10.3899/jrheum.220353. [Epub ahead of print]

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

location_country:
Poland
Taiwan
Belgium
Spain
Australia
Netherlands
Finland
Sweden
Hungary
United States
France
Colombia
Germany
Czechia

location_facility: Centro Integral de Reumatologia Reumalab S.A.S.

location_facility: Diagnostic-Med Centrum Diagnostyki Radiologicznej

location_facility: Complejo Hospitalario Universitario Santiago

location_facility: Oregon Health and Science University Research Pharmacy

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

location_facility: Swedish Medical Center Investigational Drug Services Pharmacy

location_facility: Complejo Hospitalario Regional Virgen Macarena

location_facility: VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

location_facility: Northwestern University Clinical and Translational Sciences Institute (NUCATS)

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej

location_facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob

location_facility: SANUS Szpital Specjalistyczny Sp. z o.o.

location_facility: Northwestern Medical Group; Division of Rheumatology

location_facility: Zaklad Radiologii i Diagnostyki Obrazowej

location_facility: Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1

location_facility: Complexo Hospitalario Universitario A Coruna

intervention_type: Biological


title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

ReferenceCitation: Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Büller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.

ReferenceCitation: Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.

ReferenceCitation: Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.

ReferenceCitation: Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Büller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.

ReferenceCitation: Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Büller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.

ReferenceCitation: Hokusai-VTE Investigators, Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum in: N Engl J Med. 2014 Jan 23;370(4):390.

ReferenceCitation: Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.

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

lead_sponsor: Daiichi Sankyo, Inc.

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

location_facility:
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Investigational Site 6003
Investigational Site 2917
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Investigational Site 7000
Investigational Site 1050
Investigational Site 4010
Investigational Site 1715
Investigational Site 4103
Investigational Site 7154
Investigational Site 4507
Investigational Site 2007
Investigational Site 6145
Investigational Site 3612
Investigational Site 4702
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Investigational Site 4908
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Investigational Site 2004
Investigational Site 3501
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Investigational Site 5703
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Investigational Site 1048
Investigational Site 2003
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Investigational Site 3608
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Investigational Site 3004
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Investigational Site 3500
Investigational Site 3510
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Investigational Site 2800
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title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis

summary: The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

ReferenceCitation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Portugal
Spain
United Kingdom
Russian Federation
Mexico
Argentina
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Belgium
Germany
Bulgaria
Czechia


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

ReferenceCitation: Rowe SM, Daines C, Ringshausen FC, Kerem E, Wilson J, Tullis E, Nair N, Simard C, Han L, Ingenito EP, McKee C, Lekstrom-Himes J, Davies JC. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017 Nov 23;377(21):2024-2035. doi: 10.1056/NEJMoa1709847. Epub 2017 Nov 3.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United Kingdom
Italy
Australia
Netherlands
Canada
Switzerland
United States
France
Israel
Belgium
Germany


acronym: PEMPHIX

title: A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

ReferenceCitation: Werth VP, Joly P, Mimouni D, Maverakis E, Caux F, Lehane P, Gearhart L, Kapre A, Pordeli P, Chen DM; PEMPHIX Study Group. Rituximab versus Mycophenolate Mofetil in Patients with Pemphigus Vulgaris. N Engl J Med. 2021 Jun 17;384(24):2295-2305. doi: 10.1056/NEJMoa2028564. Epub 2021 May 19.

location_country:
Brazil
Spain
Italy
Australia
Argentina
Canada
Ukraine
United States
France
Israel
Turkey
Germany

location_facility: Faculdade de Medicina de Botucatu - Hospital das Clínicas

location_facility: Centro Clinico per le genodermatosi Dipartimento di Dermatologia dell'Immacolata - IRCCS

location_facility: Gaziantep University Medical Faculty Sahinbey Hospital

location_facility: Territorial Medical Association "Dermatovenerologia"

location_facility: Los Angeles Biomedical Research Institute

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Department of Dermatology Avicenne Hospital & University

location_facility: Gülhane Military Medical Academy in Ankara

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Rambam Medical Centre; Dept. of Dermatology

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Köln

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

location_facility: Massachusetts General Hospital Dermatology

location_facility: Wake Forest Baptist Hospital Center for Dermatology Research

location_facility: Rabin Medical Centre; Dept. of Dermatology

location_facility: Kompetenzzentrum Fragile Haut Klinik fur Dermatologie und Venerologie

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Clinica Dermatologica

location_facility: University of Arizona Medical Research Office

location_facility: Università di Parma Clinica Dermatologica

location_facility: Celal Bayar University Medical Faculty Hafsa Sultan Hospital

location_facility: Ambulatorio di Malattie Rare e Immunopatologia Cutanea

location_facility: Santa Casa de São Paulo Hospital Central X

location_facility: Les Hospices Civils de Lyon Dermatologie inflammatoire et médecine interne

location_facility: U.O. Dermatologia Dipartimento Malattie Infettive Fondazione IRCCS Policlinico San Matteo

location_facility: Karadeniz Teknik Üniversitesi Tıp Fakültesi Farabi Hastanesi

location_facility: S.C. Dermatologia 2 - Ambulatorio Malattie Rare

summary:
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening.

Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness.

The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.


title: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223

summary: This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.

study_type: Observational

time_perspective: Retrospective

location_country: Brazil Spain Italy India France Turkey

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Centre Bourgogne, Service de Radiotherapie

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica

location_facility: Chg de Chartres Hopital Louis Pasteur; Pneumologie

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital Virgen de los Lirios; Servicio de Oncologia

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Complejo Hospitalario la Mancha Centro;Servicio Oncologia

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept


ipd_sharing: No

acronym: FRIDA

title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)

lead_sponsor: Dompé Farmaceutici S.p.A

ReferenceCitation: Schott AF, Goldstein LJ, Cristofanilli M, Ruffini PA, McCanna S, Reuben JM, Perez RP, Kato G, Wicha M. Phase Ib Pilot Study to Evaluate Reparixin in Combination with Weekly Paclitaxel in Patients with HER-2-Negative Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5358-5365. doi: 10.1158/1078-0432.CCR-16-2748. Epub 2017 May 24.

location_country:
Poland
Spain
Italy
France
United States
Belgium
Czechia

location_facility: Azienda Ospedaliera, Ospedale San Carlo Borromeo

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Complejo Hospitalario Universitario La Coruña

location_facility: Hematology and Oncology Associates of Northeast PA

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

location_facility: Azienda Opspedaliero Universitaria Santa Maria della Misericordia

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner. Spólka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: CBCC Global Research a Comprehensive Blood and Cancer Center

location_facility: Northside Hospital, Inc.-Georgia Cancer Specialists

location_facility: Fakultní nemocnice v Motole, Onkologická klinika 2. LF UK a FN Motol

location_facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

location_facility: Centre hospitalier de Saint-Brieuc, Yves Le Foll

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd.

location_facility: Azienda Ospedaliero - Universitaria, Policlinico Vittorio Emanuele

summary:
The Objectives of this study:

The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone.

The secondary objectives were:

To determine overall survival (OS).
To evaluate objective response rates (ORR).
To determine median PFS (mPFS).
To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).


title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma

acronym: ARTEMIS

summary:
This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy.

Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.

lead_sponsor: Morphotek

location_country:
United Kingdom
Italy
Australia
United States
France
Germany


acronym: AFFIRM

title: Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

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

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

ReferenceCitation: Zhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.

ReferenceCitation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.

ReferenceCitation: Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

ReferenceCitation: Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21. Erratum in: Clin Genitourin Cancer. 2019 Jun;17(3):240.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

ReferenceCitation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

ReferenceCitation: Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.

ReferenceCitation: Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.

ReferenceCitation: Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.

ReferenceCitation: Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.

ReferenceCitation: Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4. Erratum in: Lancet Oncol. 2014 Oct;15(11):e475.

ReferenceCitation: Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15.

location_country:
Poland
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
United Kingdom
United States
Chile
France
South Africa
Belgium
Germany

location_facility: Clinica Universitaria Privada Reina Fabiola

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: University of Colorado Denver, Anschutz Cancer Pavilion

location_facility: Sydney West Cancer Trials Centre, Department of Medical Oncology

location_facility: Instituto de Oncologia y Especialidades Medicas

location_facility: Centre de rechereche clinique et evaluative en oncologie

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie

location_facility: Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)

location_facility: Prince of Wales Hospital, Department of Medical Oncology

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: Hospital of the University of Pennsylvania

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Medical University of South Carolina (MUSC)

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Tom Baker Cancer Centre - Holy Cross Site

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Wojewodzki szpital specjalistyczny im. Janusza Korczaka

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Abt.f.Diagnostische u. Interventionelle Radiologie

location_facility: University of Pittsburgh Cancer Institute

location_facility: Centre Regional Francois Baclesse de lutte contre le cancer

location_facility: Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group

location_facility: George Washington University-Medical Faculty Associates

location_facility: North County Oncology Medical Clinic, Inc,

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Groupement Hospitalier Edouard Herriot - Pavillon V

location_facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

location_facility: Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Instituto de Investigaciones Clinicas Cipolletti

location_facility: British Columbia Cancer Agency, Centre for the Southern Interior

location_facility: Nevada Cancer Institute, an affiliate of the UC San Diego Health System

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Centre Hospitalier Intercommunal Frejus-Saint Raphael

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Stanford Hospital and Clinics Research Pharmacy

location_facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

location_facility: Sir Charles Gairdner Hospital, Department of Medical Oncology

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny

location_facility: Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin

summary: This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.


title: A Phase IIb, Double Blind Randomized, Controlled Clinical Trial, to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) - Aramchol 005 Study

summary:
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic.

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.

The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

ReferenceCitation: Ratziu V, de Guevara L, Safadi R, Poordad F, Fuster F, Flores-Figueroa J, Arrese M, Fracanzani AL, Ben Bashat D, Lackner K, Gorfine T, Kadosh S, Oren R, Halperin M, Hayardeny L, Loomba R, Friedman S; ARREST investigator study group, Sanyal AJ. Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2021 Oct;27(10):1825-1835. doi: 10.1038/s41591-021-01495-3. Epub 2021 Oct 7.

lead_sponsor: Galmed Research and Development, Ltd.

location_country:
Hong Kong
Romania
Italy
Georgia
Lithuania
United States
Chile
France
Israel
Mexico
Germany

location_facility: CHU Centre Hospiatalier Universitaire de Rennes

location_facility: Profil Institue for Clinical Research Inc.

location_facility: Consultorio Medico del Dr. Mauricio Castillo Barradas

location_facility: County Hospital Mures-Gastroenterology Department

location_facility: Vilinius University Hospital Santariskiu Klinikos

location_facility: "Ospedale Cristo Re" dell'Istituto Figlie di N.S. al Monte Calvario

location_facility: Policlinico Univestitario Campus Biomedico

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne

location_facility: Pontificia Universidad Catolica de Chile

location_facility: University of California Department of Medicine Division of Gastroenterology

location_facility: Universitat Leipzig Medizinische Fakultat

location_facility: Centre Hospitalier Universitaire (CHU) d'Angers

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: San Joseph Service Hepato Gastro Entrologie

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A.Cardarelli"

location_facility: The National Institute for Infectious Diseases "Prof. Dr. Matei Bals", Clinical Department for Adults II

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Instituto de Ciencias Medicas y de la Nutricion Salvador Zubiran

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Azienda Ospidaliera Universitaria Seconda Universita di Napoli

location_facility: Unidad de Hígado Hospital Universitario Dr. José Eleuterio González

location_facility: Gastroenterology Consultants of San Antonio


title: A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

ReferenceCitation: Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.

location_country:
Georgia
Russian Federation
Korea, Republic of
United States
France
China
Romania
Bulgaria

location_facility: 502.550.82002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01020 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01018 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302E Boehringer Ingelheim Investigational Site

location_facility: 502.550.99504 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3307A Boehringer Ingelheim Investigational Site

location_facility: 502.550.07010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99505 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35911 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302I Boehringer Ingelheim Investigational Site

location_facility: 502.550.82011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3306F Boehringer Ingelheim Investigational Site

location_facility: 502.550.40011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35902 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99508 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302D Boehringer Ingelheim Investigational Site

location_facility: 502.550.07002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01019 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301I Boehringer Ingelheim Investigational Site

location_facility: 502.550.82009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302B Boehringer Ingelheim Investigational Site

location_facility: 502.550.35904 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35901 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99506 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01015 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35909 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301K Boehringer Ingelheim Investigational Site

location_facility: 502.550.82013 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01014 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305G Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305I Boehringer Ingelheim Investigational Site

location_facility: 502.550.01004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303F Boehringer Ingelheim Investigational Site

location_facility: 502.550.07005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301F Boehringer Ingelheim Investigational Site

location_facility: 502.550.40001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99501 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35905 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35908 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01016 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99503 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99502 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304A Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303A Boehringer Ingelheim Investigational Site

location_facility: 502.550.07009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301E Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303C Boehringer Ingelheim Investigational Site

location_facility: 502.550.01012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302C Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301H Boehringer Ingelheim Investigational Site

location_facility: 502.550.82006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304F Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301J Boehringer Ingelheim Investigational Site

location_facility: 502.550.99507 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3306A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35906 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35903 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01017 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303D Boehringer Ingelheim Investigational Site

location_facility: 502.550.01001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304J Boehringer Ingelheim Investigational Site

location_facility: 502.550.07004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35910 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304D Boehringer Ingelheim Investigational Site

location_facility: 502.550.07007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302A Boehringer Ingelheim Investigational Site

location_facility: 502.550.40006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302G Boehringer Ingelheim Investigational Site

location_facility: 502.550.86003 Boehringer Ingelheim Investigational Site

summary: The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).


title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

location_country:
Croatia
Romania
Russian Federation
Estonia
Netherlands
Canada
Lithuania
Tunisia
Ukraine
Sweden
France
India
Mexico
Germany

location_facility: 1218.52.37001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37201 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91012 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2162B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38502 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38503 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37202 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38505 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91019 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2163A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91018 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2161A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91015 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9999 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2161B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9993 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9992 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91013 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38501 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91014 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38504 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52009 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2163B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91016 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37203 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2162A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31015 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3306C Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9991 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303B Boehringer Ingelheim Investigational Site

summary: A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46


title: A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

summary:
Primary objective:

Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

Compare the following parameters following 4 cycles of VD or VTD induction treatment:

CR rate+ very good partial remission (VGPR) rate
Overall remission rate (CR + VGPR + partial remission (PR) rate)
K/l light chain ratio in patients in CR.
Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).

status: Unknown status

ReferenceCitation: Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pégourié B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traullé C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.

lead_sponsor: Intergroupe Francophone du Myelome

location_country: France Belgium

location_facility:
CH La Roche Sur Yon
Lyon Léon Berard
CH Chartres
Chu Dijon
Paris St Antoine
Ch Avignon
CH BLOIS
Caen M Interne Baclèse
Bruxelles Erasme
Clamart Percy
CH Bayonne
CHU Reims
Chu Grenoble
CHU Nice M Interne
Chu Nancy
Paris Cochin
Bobigny Avicenne
CHU Lyon Sud Pierre Benite
St ETIENNE
Paris St Louis
Chu Nantes
YVOIR MontGodinne
Marseille IPC
CH Annecy
CH St Brieuc
Chu Besancon
CHU Tours
CHR Orléans
CH Roanne
CHU Clermont Ferrand
CHR Metz Bonsecours
BRUXELLES St LUC
CHU Poitiers hemato
CHU Rennes M interne
Le Mans Victor Hugo
Chu Brest
Chru Lille
Chu Angers
Nantes Catherine De Sienne
CH Vannes
Ch Lorient
Chu Toulouse
CHRU Strasbourg
ANVERS Centrumziekenhuis
Paris Hôtel Dieu
Rouen Becquerel
Ch Colmar
Chu Bordeaux
GILLY
CHU Lyon Edouard Herriot
CHU Rennes Hemato
Anvers Uza
Bruxelles I Bordet
Paris Necker
Ch Dunkerque
CH Valence


title: A DB Four-Arm, Parallel Group, Proof of Concept, Dose-Finding Adaptive Phase 2a/2b RCT to Investigate the Safety, Tolerability and Efficacy and Effect on QoL of Human Recombinant Alkaline Phosphatase in Patients With Sepsis-Associated AKI

acronym: STOP-AKI

summary: The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.

ReferenceCitation: Pickkers P, Mehta RL, Murray PT, Joannidis M, Molitoris BA, Kellum JA, Bachler M, Hoste EAJ, Hoiting O, Krell K, Ostermann M, Rozendaal W, Valkonen M, Brealey D, Beishuizen A, Meziani F, Murugan R, de Geus H, Payen D, van den Berg E, Arend J; STOP-AKI Investigators. Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1998-2009. doi: 10.1001/jama.2018.14283.

ReferenceCitation: Peters E, Mehta RL, Murray PT, Hummel J, Joannidis M, Kellum JA, Arend J, Pickkers P. Study protocol for a multicentre randomised controlled trial: Safety, Tolerability, efficacy and quality of life Of a human recombinant alkaline Phosphatase in patients with sepsis-associated Acute Kidney Injury (STOP-AKI). BMJ Open. 2016 Sep 27;6(9):e012371. doi: 10.1136/bmjopen-2016-012371.

ipd_sharing: Undecided

lead_sponsor: AM-Pharma

location_country:
Spain
Ireland
Austria
Netherlands
United Kingdom
Finland
United States
France
Belgium
Germany
Czechia

location_facility: Hospital Universitario 12 de Octubre, Unidad de Cuidados Intensivos Hospital General

location_facility: Centre Hospitalier Victor Dupouy - hopital

location_facility: Universitätsklinik für Allgemeine und Chirurgische Intensivmedizin

location_facility: Hospital Universitario Germans Trias i Pujol Medicina Intensiva Hospital General,

location_facility: University of Texas Houston Medical School

location_facility: Universitatsklinikum Jena - Klinik für Anästhesiologie und Intensivmedzin

location_facility: Universitätsmedizin Greifswald Klinik für Anästhesiologie, IntensivmedizinNotfallmedizin und Schmerzmedizin

location_facility: Helios Klinikum Erfurt -Klinik fur Anaesthesie, Intensivmedizin und Schmerztherapie

location_facility: University Hospital Frankfurt, Anaesthesia, Intensive Care Medicine & Pain Therapy

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Tampa General Hospital, Division Emergency Medicine

location_facility: Royal Surrey County Hospital - Intensive Care Unit

location_facility: Universitätsklinikum Schleswig-Holstein - Klinik für Anästhesiologie und Operative Intensivmedizin

location_facility: Medizinische Hochschule Hannover Hospital - Zentrum Innere Medizin - Klinik fuer Pneumologie

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Universitätsklinikum Hamburg Eppendorf Department Intensive Care Medicine


title: Epidemiological Study of European Cardiovascular Risk Patients: Disease Prevention and Management in Usual Daily Practice

acronym: EURIKA

summary:
The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.

The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office.

Study variables will be measured:

By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication.
By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment.
By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured.
CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceCitation: Halcox JP, Banegas JR, Roy C, Dallongeville J, De Backer G, Guallar E, Perk J, Hajage D, Henriksson KM, Borghi C. Prevalence and treatment of atherogenic dyslipidemia in the primary prevention of cardiovascular disease in Europe: EURIKA, a cross-sectional observational study. BMC Cardiovasc Disord. 2017 Jun 17;17(1):160. doi: 10.1186/s12872-017-0591-5.

ReferenceCitation: Borghi C, Rodriguez-Artalejo F, De Backer G, Dallongeville J, Medina J, Guallar E, Perk J, Banegas JR, Tubach F, Roy C, Halcox JP. The association between blood pressure and lipid levels in Europe: European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice. J Hypertens. 2016 Nov;34(11):2155-63. doi: 10.1097/HJH.0000000000001078.

ReferenceCitation: Borghi C, Tubach F, De Backer G, Dallongeville J, Guallar E, Medina J, Perk J, Roy C, Banegas JR, Rodriguez-Artalejo F, Halcox JP. Lack of control of hypertension in primary cardiovascular disease prevention in Europe: Results from the EURIKA study. Int J Cardiol. 2016 Sep 1;218:83-88. doi: 10.1016/j.ijcard.2016.05.044. Epub 2016 May 13.

ReferenceCitation: Halcox JP, Tubach F, Lopez-Garcia E, De Backer G, Borghi C, Dallongeville J, Guallar E, Medina J, Perk J, Sazova O, Sweet S, Roy C, Banegas JR, Rodriguez-Artalejo F. Low rates of both lipid-lowering therapy use and achievement of low-density lipoprotein cholesterol targets in individuals at high-risk for cardiovascular disease across Europe. PLoS One. 2015 Feb 18;10(2):e0115270. doi: 10.1371/journal.pone.0115270. eCollection 2015.

ReferenceCitation: Halcox JP, Roy C, Tubach F, Banegas JR, Dallongeville J, De Backer G, Guallar E, Sazova O, Medina J, Perk J, Steg PG, Rodríguez-Artalejo F, Borghi C. C-reactive protein levels in patients at cardiovascular risk: EURIKA study. BMC Cardiovasc Disord. 2014 Feb 24;14:25. doi: 10.1186/1471-2261-14-25.

ReferenceCitation: Halcox JP, Tubach F, Sazova O, Sweet S, Medina J; EURIKA steering committee. Reclassification of European patients' cardiovascular risk using the updated Systematic Coronary Risk Evaluation algorithm. Eur J Prev Cardiol. 2015 Feb;22(2):200-2. doi: 10.1177/2047487313507680. Epub 2013 Oct 3.

ReferenceCitation: Schmieder RE, Goebel M, Bramlage P. Barriers to cardiovascular risk prevention and management in Germany--an analysis of the EURIKA study. Vasc Health Risk Manag. 2012;8:177-86. doi: 10.2147/VHRM.S29915. Epub 2012 Mar 15.

ReferenceCitation: Dallongeville J, Banegas JR, Tubach F, Guallar E, Borghi C, De Backer G, Halcox JP, Massó-González EL, Perk J, Sazova O, Steg PG, Artalejo FR; EURIKA Investigators. Survey of physicians' practices in the control of cardiovascular risk factors: the EURIKA study. Eur J Prev Cardiol. 2012 Jun;19(3):541-50. doi: 10.1177/1741826711407705. Epub 2011 Apr 18.

ReferenceCitation: Rodríguez-Artalejo F, Guallar E, Borghi C, Dallongeville J, De Backer G, Halcox JP, Hernández-Vecino R, Jiménez FJ, Massó-González EL, Perk J, Steg PG, Banegas JR; EURIKA Investigators. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA). BMC Public Health. 2010 Jun 30;10:382. doi: 10.1186/1471-2458-10-382.

location_country:
Spain
Greece
Austria
Russian Federation
United Kingdom
Switzerland
Sweden
France
Turkey
Belgium
Norway
Germany