title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF)

summary: The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

ReferenceCitation: Blumer V, Mentz RJ, Sun JL, Butler J, Metra M, Voors AA, Hernandez AF, O'Connor CM, Greene SJ. Prognostic Role of Prior Heart Failure Hospitalization Among Patients Hospitalized for Worsening Chronic Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e007871. doi: 10.1161/CIRCHEARTFAILURE.120.007871. Epub 2021 Mar 29.

name: Division of Cardiology, Duke University School of Medicine, Durham, NC (V.B., R.J.M., A.F.H., S.J.G.)

family: Blumer

full_name: Vanessa Blumer

given: Vanessa

name: Duke Clinical Research Institute, Durham, NC (R.J.M., J.-L.S., A.F.H., S.J.G.)

family: Mentz

full_name: Robert J. Mentz

given: Robert J.

family: Sun

full_name: Jie-Lena Sun

given: Jie-Lena

name: Department of Medicine, University of Mississippi Medical Center, Jackson, MS (J.B.)

family: Butler

full_name: Javed Butler

given: Javed

name: Cardiology, ASST Spedali Civili di Brescia and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy (M.M.)

family: Metra

full_name: Marco Metra

given: Marco

name: University of Groningen, Netherlands (A.A.V.)

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

family: Hernandez

full_name: Adrian F. Hernandez

given: Adrian F.

name: Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).

family: O’Connor

full_name: Christopher M. O’Connor

given: Christopher M.

family: Greene

full_name: Stephen J. Greene

given: Stephen J.

journal_name: Circulation: Heart Failure

ReferenceCitation: Greene SJ, DeVore AD, Sheng S, Fonarow GC, Butler J, Califf RM, Hernandez AF, Matsouaka RA, Samman Tahhan A, Thomas KL, Vaduganathan M, Yancy CW, Peterson ED, O'Connor CM, Mentz RJ. Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF. JACC Heart Fail. 2019 Nov;7(11):980-992. doi: 10.1016/j.jchf.2019.07.011. Epub 2019 Oct 9.

family: DeVore

full_name: Adam D. DeVore

given: Adam D.

family: Sheng

full_name: Shubin Sheng

given: Shubin

family: Fonarow

full_name: Gregg C. Fonarow

given: Gregg C.

family: Califf

full_name: Robert M. Califf

given: Robert M.

family: Matsouaka

full_name: Roland A. Matsouaka

given: Roland A.

family: Samman Tahhan

full_name: Ayman Samman Tahhan

given: Ayman

family: Thomas

full_name: Kevin L. Thomas

given: Kevin L.

title: Representativeness of a Heart Failure Trial by Race and Sex

ReferenceCitation: Greene SJ, Hernandez AF, Sun JL, Butler J, Armstrong PW, Ezekowitz JA, Zannad F, Ferreira JP, Coles A, Metra M, Voors AA, Califf RM, O'Connor CM, Mentz RJ. Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004783. doi: 10.1161/CIRCOUTCOMES.118.004783.

name: Duke Clinical Research Institute, Durham, NC (S.J.G., A.F.H., J.-L.S., A.C., R.M.C., C.M.O., R.J.M.).

name: Division of Cardiology, Duke University School of Medicine, Durham, NC (S.J.G., A.F.H., R.M.C., R.J.M.).

name: Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.).

name: Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (P.W.A., J.A.E.).

name: Centre d’Investigation Clinique Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, France (F.Z., J.P.F.).

name: Cardiology, University of Brescia, Italy (M.M.).

name: University of Groningen, the Netherlands (A.A.V.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

ReferenceCitation: Verma AK, Sun JL, Hernandez A, Teerlink JR, Schulte PJ, Ezekowitz J, Voors A, Starling R, Armstrong P, O'Conner CM, Mentz RJ. Rate pressure product and the components of heart rate and systolic blood pressure in hospitalized heart failure patients with preserved ejection fraction: Insights from ASCEND-HF. Clin Cardiol. 2018 Jul;41(7):945-952. doi: 10.1002/clc.22981. Epub 2018 Jul 17.

name: Department of Cardiology; Washington University School of Medicine; St. Louis Missouri

name: Department of Statistics; Duke University Medical Center; Durham North Carolina

name: Department of Cardiology; Duke Clinical Research Institute, Duke Hospital; Durham North Carolina

name: Department of Cardiology, School of Medicine; University of California; San Francisco

name: Department of Health Sciences Research; Mayo Clinic; Rochester Minnesota

name: Division of Cardiology; University of Alberta; Edmonton Canada

name: Department of Cardiology; University Medical Center Groningen; Groningen the Netherlands

name: Department of Cardiology; Cleveland Clinic; Cleveland Ohio

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

ReferenceCitation: Bhatt AS, Cooper LB, Ambrosy AP, Clare RM, Coles A, Joyce E, Krishnamoorthy A, Butler J, Felker GM, Ezekowitz JA, Armstrong PW, Hernandez AF, O'Connor CM, Mentz RJ. Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). J Am Heart Assoc. 2018 Feb 3;7(3). pii: e006740. doi: 10.1161/JAHA.117.006740.

name: Department of Medicine, Duke University Medical Center, Durham, NC

name: Inova Heart & Vascular Institute, Falls Church, VA

name: Duke Clinical Research Institute, Durham, NC

name: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH

name: Stony Brook Heart Institute, Stony Brook, NY

name: Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada

journal_name: Journal of the American Heart Association

title: Interaction of Body Mass Index on the Association Between N‐Terminal‐Pro‐b‐Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND‐HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure)

ReferenceCitation: Greene SJ, Hernandez AF, Dunning A, Ambrosy AP, Armstrong PW, Butler J, Cerbin LP, Coles A, Ezekowitz JA, Metra M, Starling RC, Teerlink JR, Voors AA, O'Connor CM, Mentz RJ. Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure: From the ASCEND-HF Trial. J Am Coll Cardiol. 2017 Jun 27;69(25):3029-3039. doi: 10.1016/j.jacc.2017.04.043.

journal_name: Journal of the American College of Cardiology

title: Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure

ReferenceCitation: Greene SJ, Hernandez AF, Sun JL, Metra M, Butler J, Ambrosy AP, Ezekowitz JA, Starling RC, Teerlink JR, Schulte PJ, Voors AA, Armstrong PW, O'Connor CM, Mentz RJ. Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). Circ Heart Fail. 2016 Sep;9(9). pii: e002986. doi: 10.1161/CIRCHEARTFAILURE.116.002986.

name: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.J.G., A.F.H., A.P.A., C.M.O., R.J.M.); Duke Clinical Research Institute, Durham, NC (A.F.H., J.-L.S., A.P.A., P.J.S., C.M.O., R.J.M.); Cardiology, University of Brescia, Italy (M.M.); Division of Cardiology, Stony Brook University, NY (J.B.); Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (J.A.E., P.W.A.); Cleveland Clinic, OH (R.C.S.); Section of Cardiology, San Francisco Veterans Affairs Medical Center,...

ReferenceCitation: Ezekowitz JA, Podder M, Hernandez AF, Armstrong PW, Starling RC, O'Connor CM, Califf RM. Arrival by ambulance in acute heart failure: insights into the mode of presentation from Acute Studies of Nesiritide in Decompensated Heart Failure (ASCEND-HF). BMJ Open. 2016 Mar 17;6(3):e010201. doi: 10.1136/bmjopen-2015-010201.

ReferenceCitation: Abualnaja S, Podder M, Hernandez AF, McMurray JJ, Starling RC, O'Connor CM, Califf RM, Armstrong PW, Ezekowitz JA. Acute Heart Failure and Atrial Fibrillation: Insights From the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) Trial. J Am Heart Assoc. 2015 Aug 24;4(8):e002092. doi: 10.1161/JAHA.115.002092.

name: Canadian VIGOUR Center, Edmonton, Alberta, Canada

name: BHF Cardiovascular Research Center, University of Glasgow, Scotland

repository_institution: Australian Catholic University - Research Bank

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: Australian Catholic University - Research Bank

repositories_institution: The University of Glasgow - Enlighten: Publications

title: Acute Heart Failure and Atrial Fibrillation: Insights From the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND‐HF) Trial

ReferenceCitation: Patel PA, Heizer G, O'Connor CM, Schulte PJ, Dickstein K, Ezekowitz JA, Armstrong PW, Hasselblad V, Mills RM, McMurray JJ, Starling RC, Tang WH, Califf RM, Hernandez AF. Hypotension during hospitalization for acute heart failure is independently associated with 30-day mortality: findings from ASCEND-HF. Circ Heart Fail. 2014 Nov;7(6):918-25. doi: 10.1161/CIRCHEARTFAILURE.113.000872. Epub 2014 Oct 3.

name: From the Duke Clinical Research Institute, Durham, NC (P.A.P., G.H., C.M.O., P.J.S., V.H., R.M.C., A.F.H.); Duke University Medical Center, Durham, NC (C.M.O., R.M.C., A.F.H.); Central Hospital Cardiology Division, Stavanger, Norway (K.D.); Division of Cardiology, Department of Medicine, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Canada (J.A.E., P.W.A.); Janssen Research & Development, LLC, Raritan, NJ (R.M.M.); Institute of Cardiovascular and Medical Sciences, BHF...

title: Hypotension During Hospitalization for Acute Heart Failure Is Independently Associated With 30-Day Mortality

ReferenceCitation: van Deursen VM, Hernandez AF, Stebbins A, Hasselblad V, Ezekowitz JA, Califf RM, Gottlieb SS, O'Connor CM, Starling RC, Tang WH, McMurray JJ, Dickstein K, Voors AA. Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: results from the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF). Circulation. 2014 Sep 16;130(12):958-65. doi: 10.1161/CIRCULATIONAHA.113.003046. Epub 2014 Jul 29.

name: From the Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands (V.M.v.D., A.A.V.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (A.F.H., A.S., V.H., C.M.O., R.C.S.); Mazankowski Alberta Heart Institute, Edmonton, Canada (J.A.E.); Duke Translational Medicine Institute, Durham, NC (R.M.C.); University of Maryland Hospital, Division of Cardiology, Baltimore, MD (S.S.G.); Cleveland Clinic Foundation, Cleveland, OH (W.H.W.T...

title: Nesiritide, Renal Function, and Associated Outcomes During Hospitalization for Acute Decompensated Heart Failure

ReferenceCitation: Kaul P, Reed SD, Hernandez AF, Howlett JG, Ezekowitz JA, Li Y, Zheng Y, Rouleau JL, Starling RC, O'Connor CM, Califf RM, Armstrong PW. Differences in treatment, outcomes, and quality of life among patients with heart failure in Canada and the United States. JACC Heart Fail. 2013 Dec;1(6):523-30. doi: 10.1016/j.jchf.2013.07.004. Epub 2013 Oct 23.

title: Differences in Treatment, Outcomes, and Quality of Life Among Patients With Heart Failure in Canada and the United States

ReferenceCitation: Toma M, Ezekowitz JA, Bakal JA, O'Connor CM, Hernandez AF, Sardar MR, Zolty R, Massie BM, Swedberg K, Armstrong PW, Starling RC. The relationship between left ventricular ejection fraction and mortality in patients with acute heart failure: insights from the ASCEND-HF Trial. Eur J Heart Fail. 2014 Mar;16(3):334-41. doi: 10.1002/ejhf.19. Epub 2013 Dec 14.

name: Division of Cardiology; St. Paul's Hospital, University of British Columbia; Vancouver Canada

name: Division of Cardiology, Department of Medicine; University of Alberta, Mazankowski Alberta Heart Institute; 2C2 WMC-8440-112 Street, Edmonton Canada T6G 2B7

name: Canadian VIGOUR Center; University of Alberta; Edmonton Canada

name: Duke Clinical Research Institute; Durham NC USA

name: Division of Cardiology; Montefiore Medical Center; Bronx NY USA

name: Division of Cardiology; San Francisco VA Medical Center; San Francisco CA USA

name: Sahlgrenska University Hospital/Östra-Goteborg University; Sweden

name: Department of Cardiovascular Medicine; Kaufman Center for Heart Failure, Heart and Vascular Institute, Cleveland Clinic; Cleveland OH USA

ReferenceCitation: Reed SD, Kaul P, Li Y, Eapen ZJ, Davidson-Ray L, Schulman KA, Massie BM, Armstrong PW, Starling RC, O'Connor CM, Hernandez AF, Califf RM. Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF. J Card Fail. 2013 Sep;19(9):611-20. doi: 10.1016/j.cardfail.2013.07.003.

title: Medical Resource Use, Costs, and Quality of Life in Patients With Acute Decompensated Heart Failure: Findings From ASCEND-HF

ReferenceCitation: Howlett JG, Ezekowitz JA, Podder M, Hernandez AF, Diaz R, Dickstein K, Dunlap ME, Corbalán R, Armstrong PW, Starling RC, O'Connor CM, Califf RM, Fonarow GC; ASCEND-HF Investigators. Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: findings from the acute study clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF). Circ Cardiovasc Qual Outcomes. 2013 Sep 1;6(5):534-42. doi: 10.1161/CIRCOUTCOMES.113.000119. Epub 2013 Jul 30.

name: From the Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada (J.G.H.); Division of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada (J.A.E., M.P., P.W.A.); Duke Clinical Research Institute, Durham, NC (A.F.H., C.M.O., R.M.C.); Estudios Clínicos Latinoamérica (ECLA) International, Rosario, Argentina (R.D.); Central Hospital in Rogaland, University of Bergen, Bergen, Norway (K.D.); MetroHealth Campus and Department...

title: Global Variation in Quality of Care Among Patients Hospitalized With Acute Heart Failure in an International Trial

ReferenceCitation: Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong PW, Starling RC, McMurray JJ, Massie BM, Swedberg K, Ezekowitz JA, Fonarow GC, Teerlink JR, Metra M, Whellan DJ, O'Connor CM, Califf RM, Hernandez AF. Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF. Circ Heart Fail. 2013 Jul;6(4):727-32. doi: 10.1161/CIRCHEARTFAILURE.112.000265. Epub 2013 Jun 14.

name: From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (Z.J.E., S.D.R., Y.L., C.M.O., R.M.C., A.F.H.); Tufts Medical Center and Tufts University School of Medicine, Boston, MA (R.D.K.); University of Alberta, Edmonton, Alberta, Canada (P.W.A., J.A.E.); Cleveland Clinic, Cleveland, OH (R.C.S.); University of Glasgow, Glasgow, United Kingdom (J.J.M.); University of California, San Francisco, and San Francisco Department of Veterans Affairs Health Care System, San...

title: Do Countries or Hospitals With Longer Hospital Stays for Acute Heart Failure Have Lower Readmission Rates?

ReferenceCitation: Ezekowitz JA, Hu J, Delgado D, Hernandez AF, Kaul P, Leader R, Proulx G, Virani S, White M, Zieroth S, O'Connor C, Westerhout CM, Armstrong PW. Acute heart failure: perspectives from a randomized trial and a simultaneous registry. Circ Heart Fail. 2012 Nov;5(6):735-41. doi: 10.1161/CIRCHEARTFAILURE.112.968974. Epub 2012 Oct 2.

name: From the Mazankowski Alberta Heart Institute and the University of Alberta, Edmonton, AB, Canada (J.A.E., J.H., P.K., C.M.W., P.W.A.); University of British Columbia, Vancouver, BC, Canada (S.V.); Rouge Valley Health System, Ajax, ON, Canada (R.L.); Montreal Heart Institute, Montreal, QC, Canada (M.W.); University of Manitoba, Winnipeg, MB, Canada (S.Z.); University Health Network, Toronto, ON, Canada (D.D.); Laval University, Quebec City, QC, Canada (G.P.); and Duke Clinical Research Institute,...

title: Acute Heart Failure

ReferenceCitation: Ezekowitz JA, Hernandez AF, O'Connor CM, Starling RC, Proulx G, Weiss MH, Bakal JA, Califf RM, McMurray JJ, Armstrong PW. Assessment of dyspnea in acute decompensated heart failure: insights from ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) on the contributions of peak expiratory flow. J Am Coll Cardiol. 2012 Apr 17;59(16):1441-8. doi: 10.1016/j.jacc.2011.11.061.

title: Assessment of Dyspnea in Acute Decompensated Heart Failure

ReferenceCitation: O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalán R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Méndez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. Erratum in: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

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

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

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

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

title: Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

location_country:
Malaysia
Greece
Australia
Russian Federation
Taiwan
Ukraine
India
France
Poland
Lithuania
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Netherlands
Bulgaria
Singapore
China
Germany
United States
Brazil
Mexico
Israel
New Zealand


title: A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.

acronym: FUTURE

summary: This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Douillard JY, Zemelka T, Fountzilas G, Barone C, Schlichting M, Heighway J, Eggleton SP, Srimuninnimit V. FOLFOX4 with cetuximab vs. UFOX with cetuximab as first-line therapy in metastatic colorectal cancer: The randomized phase II FUTURE study. Clin Colorectal Cancer. 2014 Mar;13(1):14-26.e1. doi: 10.1016/j.clcc.2013.11.009. Epub 2013 Nov 16.

family: Douillard

full_name: Jean-Yves Douillard

given: Jean-Yves

sequence: first

family: Zemelka

full_name: Tomasz Zemelka

given: Tomasz

sequence: additional

family: Fountzilas

full_name: George Fountzilas

given: George

family: Barone

full_name: Carlo Barone

given: Carlo

family: Schlichting

full_name: Michael Schlichting

given: Michael

family: Heighway

full_name: Jim Heighway

given: Jim

family: Eggleton

full_name: S. Peter Eggleton

given: S. Peter

family: Srimuninnimit

full_name: Vichien Srimuninnimit

given: Vichien

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Colorectal Cancer

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: FOLFOX4 With Cetuximab vs. UFOX With Cetuximab as First-Line Therapy in Metastatic Colorectal Cancer: The Randomized Phase II FUTURE Study

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Italy
Austria
Brazil
Hong Kong
Mexico
France
Poland
Greece
Israel
Thailand
Argentina
Australia
Belgium
Germany

location_facility:
Research site
Research Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

ReferenceType: derived

ReferenceCitation: Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreño L, Armstrong G, Collinson N, Shaw TM; MIRROR Trial Investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford). 2010 Sep;49(9):1683-93. doi: 10.1093/rheumatology/keq116. Epub 2010 May 12.

family: Rubbert-Roth

full_name: A. Rubbert-Roth

given: A.

family: Tak

full_name: P. P. Tak

given: P. P.

family: Zerbini

full_name: C. Zerbini

given: C.

family: Tremblay

full_name: J.-L. Tremblay

family: Carreno

full_name: L. Carreno

given: L.

family: Armstrong

full_name: G. Armstrong

given: G.

family: Collinson

full_name: N. Collinson

given: N.

family: Shaw

full_name: T. M. Shaw

given: T. M.

name: on behalf of the MIRROR Trial Investigators

journal_name: Rheumatology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
South Africa
Netherlands
Spain
Germany
Finland
France
Thailand
Slovakia
Hungary
Belgium
Australia
New Zealand
China
Canada
United Kingdom
Taiwan


title: A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

summary: Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

ReferenceCitation: Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12.

family: Zinzani

full_name: P.L. Zinzani

family: Vose

full_name: J.M. Vose

family: Czuczman

full_name: M.S. Czuczman

family: Reeder

full_name: C.B. Reeder

family: Haioun

full_name: C. Haioun

family: Polikoff

full_name: J. Polikoff

given: J.

family: Tilly

full_name: H. Tilly

given: H.

family: Zhang

full_name: L. Zhang

family: Prandi

full_name: K. Prandi

given: K.

family: Li

full_name: J. Li

family: Witzig

full_name: T.E. Witzig

journal_name: Annals of Oncology

evidence: open (via crossref license)

ReferenceCitation: Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-1627. doi: 10.1093/annonc/mdq626. Epub 2011 Jan 12.

family: Buckstein

full_name: R. Buckstein

given: R.

full_name: J.A. Polikoff

family: Bouabdallah

full_name: R. Bouabdallah

title: An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Michigan Hematology and Oncology Institute

location_facility: Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina

location_facility: Hopital Saint Louis Service d'Hémato-Oncologie

location_facility: Centre Hospitalier Lyon Sud, Hematologie Clinique

location_facility: Department d'Hématologie Centre Henri Becquerel

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),

location_facility: Complexo Hospitalario de Pontevedra Oncology Department

location_facility: Hematology Oncology Associates of Central Brevard

location_facility: Hospital Clinico Universitario de Salamanca, Servicio de Hematologia

location_facility: Institute Paoli-Calmettes Départmentd 'Hématologie

location_facility: Medical Oncology, Christie Hospital NHS Trust

location_facility: Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"

location_facility: Royal Marsden Hospital NHS Foundation Trust London and Surrey

location_facility: Hospital Clinicio San Carlos, Servivio de Hematologia Clinica

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Center for Cancer and Hematologic Disease

location_facility: Hospital Universitario Virgen de la Victoria, Servicio de oncologia

location_facility: Hospital Clinic I Provincial, Servicio de Hematologia

location_facility: Sylvester Cancer Center/ Univeristy of Miami

location_facility: CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale


ReferenceCitation: Stein A, Bellmunt J, Escudier B, Kim D, Stergiopoulos SG, Mietlowski W, Motzer RJ; RECORD-1 Trial Study Group. Survival prediction in everolimus-treated patients with metastatic renal cell carcinoma incorporating tumor burden response in the RECORD-1 trial. Eur Urol. 2013 Dec;64(6):994-1002. doi: 10.1016/j.eururo.2012.11.032. Epub 2012 Nov 21.

family: Stein

full_name: Andrew Stein

given: Andrew

family: Bellmunt

full_name: Joaquim Bellmunt

given: Joaquim

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Kim

full_name: Dennis Kim

given: Dennis

family: Stergiopoulos

full_name: Sotirios G. Stergiopoulos

given: Sotirios G.

family: Mietlowski

full_name: William Mietlowski

given: William

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

journal_name: European Urology

title: Survival Prediction in Everolimus-treated Patients with Metastatic Renal Cell Carcinoma Incorporating Tumor Burden Response in the RECORD-1 Trial

ReferenceCitation: Stein A, Wang W, Carter AA, Chiparus O, Hollaender N, Kim H, Motzer RJ, Sarr C. Dynamic tumor modeling of the dose-response relationship for everolimus in metastatic renal cell carcinoma using data from the phase 3 RECORD-1 trial. BMC Cancer. 2012 Jul 23;12:311. doi: 10.1186/1471-2407-12-311.

family: Wang

full_name: Wenping Wang

given: Wenping

family: Carter

full_name: Alison A Carter

given: Alison A

family: Chiparus

full_name: Ovidiu Chiparus

given: Ovidiu

family: Hollaender

full_name: Norbert Hollaender

given: Norbert

full_name: Hyewon Kim

given: Hyewon

full_name: Robert J Motzer

given: Robert J

family: Sarr

full_name: Celine Sarr

given: Celine

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Dynamic tumor modeling of the dose–response relationship for everolimus in metastatic renal cell carcinoma using data from the phase 3 RECORD-1 trial

ReferenceCitation: Oudard S, Thiam R, Fournier LS, Medioni J, Lamuraglia M, Scotte F, Fabre E, Kim D, Kpamegan E, Panneerselvam A, Cuenod CA. Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: analysis of response and progression-free survival in the RECORD-1 study. Eur J Cancer. 2012 Jul;48(10):1512-8. doi: 10.1016/j.ejca.2012.01.027. Epub 2012 Feb 16.

title: Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: Analysis of response and progression-free survival in the RECORD-1 study

ReferenceCitation: Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grünwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ. Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: an exploratory analysis of the outcomes of elderly patients in the RECORD-1 Trial. Eur Urol. 2012 Apr;61(4):826-33. doi: 10.1016/j.eururo.2011.12.057. Epub 2012 Jan 5.

title: Efficacy and Safety of Everolimus in Elderly Patients With Metastatic Renal Cell Carcinoma: An Exploratory Analysis of the Outcomes of Elderly Patients in the RECORD-1 Trial

ReferenceCitation: Calvo E, Escudier B, Motzer RJ, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Ravaud A, Kim D, Panneerselvam A, Anak O, Figlin RA. Everolimus in metastatic renal cell carcinoma: Subgroup analysis of patients with 1 or 2 previous vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapies enrolled in the phase III RECORD-1 study. Eur J Cancer. 2012 Feb;48(3):333-9. doi: 10.1016/j.ejca.2011.11.027. Epub 2011 Dec 30.

ReferenceCitation: White DA, Camus P, Endo M, Escudier B, Calvo E, Akaza H, Uemura H, Kpamegan E, Kay A, Robson M, Ravaud A, Motzer RJ. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med. 2010 Aug 1;182(3):396-403. doi: 10.1164/rccm.200911-1720OC. Epub 2010 Mar 1.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Noninfectious Pneumonitis after Everolimus Therapy for Advanced Renal Cell Carcinoma

ReferenceCitation: Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. doi: 10.1016/S0140-6736(08)61039-9. Epub 2008 Jul 22.

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Poland
Australia
Spain
Canada

title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor

summary: To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.


title: A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

acronym: HORIZON III

summary: The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

study_start_date_type: Actual

ReferenceCitation: Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.

family: Abdel-Rahman

full_name: Omar Abdel-Rahman

given: Omar

ReferenceCitation: Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.

ReferenceCitation: Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.

family: Robertson

full_name: Jane D. Robertson

given: Jane D.

family: Botwood

full_name: Nick A. Botwood

given: Nick A.

family: Rothenberg

full_name: Mace L. Rothenberg

given: Mace L.

family: Schmoll

full_name: Hans-Joachim Schmoll

given: Hans-Joachim

title: Phase III Trial of FOLFOX plus Bevacizumab or Cediranib (AZD2171) as First-Line Treatment of Patients with Metastatic Colorectal Cancer: HORIZON III

lead_sponsor: AstraZeneca

location_country:
Finland
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
India
France
Poland
Thailand
Slovakia
Canada
South Africa
Vietnam
Philippines
Malta
Hungary
United States
Germany
United Kingdom
Italy
Austria
Israel
Egypt
Spain
Turkey
Latvia


title: A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

summary: This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

ReferenceCitation: Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.

name: From the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Vrije University Medical Center, Amsterdam; Eli Lilly Netherlands, Utrecht, the Netherlands; Christie Hospital, Manchester, United Kingdom; US Oncology, Houston, TX; Hospital Grosshansdorf, Grosshansdorf; Department of Medicine and Medical Oncology, St Georg Hospital, Hamburg, Germany; Mazovian Center of Lung Diseases and Tuberculosis, Otwock; Sokolowski Specialist Hospital in Szczecin-Zdunowo; Medical...

family: Socinski

full_name: Mark A. Socinski

given: Mark A.

family: Smit

full_name: Egbert F. Smit

given: Egbert F.

family: Lorigan

full_name: Paul Lorigan

given: Paul

family: Konduri

full_name: Kartik Konduri

given: Kartik

family: Reck

full_name: Martin Reck

given: Martin

family: Szczesna

full_name: Aleksandra Szczesna

given: Aleksandra

family: Blakely

full_name: Johnetta Blakely

given: Johnetta

family: Serwatowski

full_name: Piotr Serwatowski

given: Piotr

family: Karaseva

full_name: Nina A. Karaseva

given: Nina A.

family: Ciuleanu

full_name: Tudor Ciuleanu

given: Tudor

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Dediu

full_name: Mircea Dediu

given: Mircea

family: Hong

full_name: Shengyan Hong

given: Shengyan

family: Visseren-Grul

full_name: Carla Visseren-Grul

given: Carla

family: Hanauske

full_name: Axel-Rainer Hanauske

given: Axel-Rainer

family: Obasaju

full_name: Coleman K. Obasaju

given: Coleman K.

family: Guba

full_name: Susan C. Guba

given: Susan C.

family: Thatcher

full_name: Nick Thatcher

given: Nick

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Study of Pemetrexed Plus Carboplatin Compared With Etoposide Plus Carboplatin in Chemotherapy-Naive Patients With Extensive-Stage Small-Cell Lung Cancer

lead_sponsor: Eli Lilly and Company

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
India
France
Poland
Argentina
Korea, Republic of
South Africa
Netherlands
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
New Zealand
Spain
Turkey

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


title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype

summary:
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

ReferenceCitation: Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004.

family: Bateman

full_name: Eric D. Bateman

given: Eric D.

family: Kornmann

full_name: Oliver Kornmann

given: Oliver

family: Schmidt

full_name: Peter Schmidt

given: Peter

family: Pivovarova

full_name: Anna Pivovarova

given: Anna

family: Engel

full_name: Michael Engel

given: Michael

family: Fabbri

full_name: Leonardo M. Fabbri

given: Leonardo M.

journal_name: Journal of Allergy and Clinical Immunology

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
South Africa
Finland
France
Greece
Slovakia
Belgium
Russian Federation
Spain
Turkey
Denmark
Germany
United Kingdom

location_facility: 205.342.27004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42103 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42104 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39010 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39006 Azienda Ospedaliera Universitaria Careggi

location_facility: 205.342.34008 Hospital Universitario Marqués de Valdecilla

location_facility: 205.342.43003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49016 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42101 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90005 Kocaeli Universitesi Tip Fakultesi

location_facility: 205.342.34003 Hospital Universitario La Paz

location_facility: 205.342.30006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32012 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35801 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90004 Celal Bayar Universitesi Tip Fakultesi

location_facility: 205.342.07004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34004 Hospital General Universitario de Guadalajara

location_facility: 205.342.32003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34006 Hospital Clinic i Provincial de Barcelona

location_facility: 205.342.90003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35804 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49009 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34011 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49011 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27008 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42102 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35803 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3307A Boehringer Ingelheim Investigational Site

location_facility: 205.342.42106 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34007 Hospital Universitari Arnau de Vilanova

location_facility: 205.342.39009 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3302A Hôpital Arnaud de Villeneuve

location_facility: 205.342.3305A Centre Hosp de la Cavale Blanche

location_facility: 205.342.39002 Università di Modena e Reggio Emilia

location_facility: 205.342.32011 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39003 Azienda Ospedaliera " S. Anna"

location_facility: 205.342.44003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35802 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42107 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3308A Boehringer Ingelheim Investigational Site

location_facility: 205.342.32014 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32009 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: 205.342.49015 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42108 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32010 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49010 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49008 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34009 Hospital Universio Puerta del Hierro

location_facility: 205.342.49013 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42105 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34002 Hospital de Gran Canaria Dr. Negrín

location_facility: 205.342.49012 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34010 Hospital General Universitario de Valencia

location_facility: 205.342.3308B Boehringer Ingelheim Investigational Site

location_facility: 205.342.34005 Hospital Vírgen de la Macarena

location_facility: 205.342.07008 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32013 Boehringer Ingelheim Investigational Site


type: EudraCT Number

title: A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

summary: This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

name: All authors: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

family: Wedam

full_name: Suparna B. Wedam

given: Suparna B.

family: Beaver

full_name: Julia A. Beaver

given: Julia A.

family: Amiri-Kordestani

full_name: Laleh Amiri-Kordestani

given: Laleh

family: Bloomquist

full_name: Erik Bloomquist

given: Erik

family: Tang

full_name: Shenghui Tang

given: Shenghui

family: Goldberg

full_name: Kirsten B. Goldberg

given: Kirsten B.

family: Sridhara

full_name: Rajeshwari Sridhara

given: Rajeshwari

family: Ibrahim

full_name: Amna Ibrahim

given: Amna

family: Kim

full_name: Geoffrey Kim

given: Geoffrey

family: Kluetz

full_name: Paul Kluetz

given: Paul

family: McKee

full_name: Amy McKee

given: Amy

family: Pazdur

full_name: Richard Pazdur

given: Richard

oa_host_type: repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
Romania
Australia
Belgium
Taiwan
France
Panama
Lithuania
Poland
Thailand
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Spain


title: Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy

summary: This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

status: Terminated

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Brazil
Hong Kong
France
Israel
Singapore
Spain
Denmark
Germany
United Kingdom
Taiwan

status_simplified: Unknown


title: A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy

summary: This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.

location_country:
Italy
Austria
Hong Kong
Germany
Finland
France
Poland
Greece
Hungary
Australia
Belgium
Spain
Estonia
Canada
Czech Republic


title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

ReferenceCitation: Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015 Apr 1;33(10):1191-6. doi: 10.1200/JCO.2014.56.6018. Epub 2015 Feb 23.

name: Michele Maio, University Hospital of Siena, Siena; Vanna Chiarion-Sileni, Veneto Oncology Institute-Istituto Di Ricovero e Cura a Carattere Scientifico, Padova; Alessandro Testori, Istituto Europeo di Oncologia, Milan, Italy; Jean-Jacques Grob, Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille, Hôpital Timone, Marseille; Luc Thomas, Lyon 1 University, Centre Hospitalier Lyon Sud, Pierre Bénite; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Steinar Aamdal, Oslo University...

family: Maio

full_name: Michele Maio

given: Michele

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Aamdal

full_name: Steinar Aamdal

given: Steinar

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Robert

full_name: Caroline Robert

given: Caroline

family: Thomas

full_name: Luc Thomas

given: Luc

family: Garbe

full_name: Claus Garbe

given: Claus

family: Chiarion-Sileni

full_name: Vanna Chiarion-Sileni

given: Vanna

family: Testori

full_name: Alessandro Testori

given: Alessandro

family: Chen

full_name: Tai-Tsang Chen

given: Tai-Tsang

family: Tschaika

full_name: Marina Tschaika

given: Marina

family: Wolchok

full_name: Jedd D. Wolchok

given: Jedd D.

publisher_group: American Society of Clinical Oncology (ASCO)

title: Five-Year Survival Rates for Treatment-Naive Patients With Advanced Melanoma Who Received Ipilimumab Plus Dacarbazine in a Phase III Trial

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

name: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman,...

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Hodi

full_name: F. Stephen Hodi

given: F. Stephen

family: Weber

full_name: Jeffrey S. Weber

given: Jeffrey S.

family: Margolin

full_name: Kim Margolin

given: Kim

family: Hamid

full_name: Omid Hamid

given: Omid

family: Patt

full_name: Debra Patt

given: Debra

ReferenceCitation: Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.

title: Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma

location_country:
Australia
Belgium
Russian Federation
Czech Republic
Ukraine
France
Poland
Norway
Argentina
Canada
South Africa
Chile
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Saint Francis Hospital And Medical Center

location_facility: Cancer Specialists Of North Florida Beaches

location_facility: Hematology Oncology Associates Of The Treasure Coast

location_facility: The Angeles Clinic And Research Institute

location_facility: Mid-Illinois Hematology/Oncology Associates, Ltd.

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: Orlando Health, Inc. M.D. Anderson Cancer Center Orlando


title: A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.

summary: The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.

primary_purpose: Prevention

ReferenceCitation: APPRAISE Steering Committee and Investigators, Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.

journal_name: Circulation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Apixaban, an Oral, Direct, Selective Factor Xa Inhibitor, in Combination With Antiplatelet Therapy After Acute Coronary Syndrome

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Sweden
Germany
France
Poland
Israel
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University Of Texas Medical School - San Antonio

location_facility: Scottsdale Cardiovasular Research Institute

location_facility: Los Angeles County & University Of Southern Ca. Medical Cen.


title: A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

acronym: ZODIAC

summary:
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.

This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.

All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.

In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.

Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.

Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

ReferenceCitation: Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.

name: Centre for Applied Pharmacokinetic Research University of Manchester  UK

name: Division of Pharmacy and Optometry University of Manchester  UK

family: Lombard

full_name: Aurélie Lombard

given: Aurélie

name: Division of Cancer Sciences University of Manchester  UK

family: Mistry

full_name: Hitesh Mistry

given: Hitesh

family: Aarons

full_name: Leon Aarons

given: Leon

family: Ogungbenro

full_name: Kayode Ogungbenro

given: Kayode

journal_name: British Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Dose individualisation in oncology using chemotherapy‐induced neutropenia: Example of docetaxel in non‐small cell lung cancer patients

ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

family: Platt

full_name: Adam Platt

given: Adam

family: Morten

full_name: John Morten

given: John

family: Ji

full_name: Qunsheng Ji

given: Qunsheng

family: Elvin

full_name: Paul Elvin

given: Paul

family: Womack

full_name: Chris Womack

given: Chris

family: Su

full_name: Xinying Su

given: Xinying

family: Donald

full_name: Emma Donald

given: Emma

family: Gray

full_name: Neil Gray

given: Neil

family: Read

full_name: Jessica Read

given: Jessica

family: Bigley

full_name: Graham Bigley

given: Graham

family: Blockley

full_name: Laura Blockley

given: Laura

family: Cresswell

full_name: Carl Cresswell

given: Carl

family: Dale

full_name: Angela Dale

given: Angela

family: Davies

full_name: Amanda Davies

given: Amanda

family: Zhang

full_name: Tianwei Zhang

given: Tianwei

family: Fan

full_name: Shuqiong Fan

given: Shuqiong

family: Fu

full_name: Haihua Fu

ReferenceCitation: Heymach JV, Lockwood SJ, Herbst RS, Johnson BE, Ryan AJ. EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer. Ann Oncol. 2014 Oct;25(10):1941-1948. doi: 10.1093/annonc/mdu269. Epub 2014 Jul 23.

ReferenceCitation: Herbst RS, Sun Y, Eberhardt WE, Germonpré P, Saijo N, Zhou C, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H, Johnson BE. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2010 Jul;11(7):619-26. doi: 10.1016/S1470-2045(10)70132-7.

location_country:
Malaysia
Greece
Belgium
Denmark
India
France
Japan
Thailand
Argentina
Indonesia
Canada
Korea, Republic of
Netherlands
Vietnam
Singapore
China
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
Spain
Turkey


title: A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.

acronym: RESTORE

summary: Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
France
Poland
Romania
Hungary
Australia
Belgium
Spain
Germany
Czech Republic


title: Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

acronym: IMPROVIT

summary: Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.

lead_sponsor: Pfizer

location_country:
Jordan
Switzerland
Spain
United Kingdom
France
Greece
Russian Federation
Egypt
Portugal
Turkey
Canada
Czech Republic


title: Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis

summary: The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.

location_country:
Italy
Austria
South Africa
Sweden
Netherlands
France
Poland
Israel
Australia
United States
Czech Republic


title: A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

summary: This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

ReferenceCitation: Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447.

name: Department of Surgery; Chinese University of Hong Kong; Hong Kong SAR China

family: Lau

full_name: James Lau

given: James

family: Lind

full_name: Tore Lind

given: Tore

family: Persson

full_name: Tore Persson

family: Eklund

full_name: Stefan Eklund

given: Stefan

journal_name: Journal of Digestive Diseases

ReferenceCitation: Kuipers EJ, Sung JJ, Barkun A, Mössner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15.

family: Kuipers

full_name: Ernst J. Kuipers

given: Ernst J.

family: Sung

full_name: Joseph J. Y. Sung

given: Joseph J. Y.

family: Barkun

full_name: Alan Barkun

given: Alan

family: Mössner

full_name: Joachim Mössner

given: Joachim

family: Jensen

full_name: Dennis Jensen

given: Dennis

family: Stuart

full_name: Robert Stuart

given: Robert

full_name: James Y. W. Lau

given: James Y. W.

family: Ahlbom

full_name: Henrik Ahlbom

given: Henrik

family: Kilhamn

full_name: Jan Kilhamn

given: Jan

journal_name: Advances in Therapy

ReferenceCitation: Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mössner J, Jensen D, Stuart R, Lau JY, Nauclér E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. Pharmacoeconomics. 2010;28(3):217-30. doi: 10.2165/11531480-000000000-00000.

full_name: Alan N. Barkun

given: Alan N.

family: Adam

full_name: Viviane Adam

given: Viviane

full_name: Joseph J.Y. Sung

given: Joseph J.Y.

title: Cost Effectiveness of High-Dose Intravenous Esomeprazole for Peptic Ulcer Bleeding

ReferenceCitation: Sung JJ, Barkun A, Kuipers EJ, Mössner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. Epub 2009 Feb 16.

location_country:
Austria
South Africa
Sweden
Hong Kong
Netherlands
Finland
France
Greece
Norway
Romania
Russian Federation
Spain
Turkey
Denmark
Germany
United Kingdom


title: A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer

summary: The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

location_country:
Finland
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
South Africa
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey


title: A 104-Week, Open-label, Multi-centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography Who Have Coronary Artery Disease

summary: The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries

design_allocation: Non-Randomized

ReferenceCitation: Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. Epub 2006 Mar 13.

location_country:
Italy
United States
Netherlands
France
Belgium
Australia
Spain
Canada


type: Other Identifier

title: Fabry Disease Registry Protocol

summary:
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The primary objectives of the Registry are:

To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease;
To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care;
To characterize and describe the Fabry population as a whole;
To evaluate the long-term safety and effectiveness of Fabrazyme®

Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Germain DP, Brand E, Burlina A, Cecchi F, Garman SC, Kempf J, Laney DA, Linhart A, Maródi L, Nicholls K, Ortiz A, Pieruzzi F, Shankar SP, Waldek S, Wanner C, Jovanovic A. Phenotypic characteristics of the p.Asn215Ser (p.N215S) GLA mutation in male and female patients with Fabry disease: A multicenter Fabry Registry study. Mol Genet Genomic Med. 2018 Apr 12. doi: 10.1002/mgg3.389. [Epub ahead of print]

ReferenceCitation: Wilcox WR, Feldt-Rasmussen U, Martins AM, Ortiz A, Lemay RM, Jovanovic A, Germain DP, Varas C, Nicholls K, Weidemann F, Hopkin RJ. Improvement of Fabry Disease-Related Gastrointestinal Symptoms in a Significant Proportion of Female Patients Treated with Agalsidase Beta: Data from the Fabry Registry. JIMD Rep. 2018;38:45-51. doi: 10.1007/8904_2017_28. Epub 2017 May 17.

ReferenceCitation: Hopkin RJ, Cabrera G, Charrow J, Lemay R, Martins AM, Mauer M, Ortiz A, Patel MR, Sims K, Waldek S, Warnock DG, Wilcox WR. Risk factors for severe clinical events in male and female patients with Fabry disease treated with agalsidase beta enzyme replacement therapy: Data from the Fabry Registry. Mol Genet Metab. 2016 Sep;119(1-2):151-9. doi: 10.1016/j.ymgme.2016.06.007. Epub 2016 Jun 13.

ReferenceCitation: Ortiz A, Abiose A, Bichet DG, Cabrera G, Charrow J, Germain DP, Hopkin RJ, Jovanovic A, Linhart A, Maruti SS, Mauer M, Oliveira JP, Patel MR, Politei J, Waldek S, Wanner C, Yoo HW, Warnock DG. Time to treatment benefit for adult patients with Fabry disease receiving agalsidase β: data from the Fabry Registry. J Med Genet. 2016 Jul;53(7):495-502. doi: 10.1136/jmedgenet-2015-103486. Epub 2016 Mar 18.

family: Ortiz

full_name: Alberto Ortiz

given: Alberto

family: Abiose

full_name: Ademola Abiose

given: Ademola

family: Bichet

full_name: Daniel G Bichet

given: Daniel G

family: Cabrera

full_name: Gustavo Cabrera

given: Gustavo

family: Charrow

full_name: Joel Charrow

given: Joel

family: Germain

full_name: Dominique P Germain

given: Dominique P

family: Hopkin

full_name: Robert J Hopkin

given: Robert J

family: Jovanovic

full_name: Ana Jovanovic

given: Ana

family: Linhart

full_name: Aleš Linhart

given: Aleš

family: Maruti

full_name: Sonia S Maruti

given: Sonia S

family: Mauer

full_name: Michael Mauer

given: Michael

family: Oliveira

full_name: João P Oliveira

given: João P

family: Patel

full_name: Manesh R Patel

given: Manesh R

family: Politei

full_name: Juan Politei

given: Juan

family: Waldek

full_name: Stephen Waldek

given: Stephen

family: Wanner

full_name: Christoph Wanner

given: Christoph

family: Yoo

full_name: Han-Wook Yoo

given: Han-Wook

family: Warnock

full_name: David G Warnock

given: David G

journal_name: Journal of Medical Genetics

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Germain DP, Charrow J, Desnick RJ, Guffon N, Kempf J, Lachmann RH, Lemay R, Linthorst GE, Packman S, Scott CR, Waldek S, Warnock DG, Weinreb NJ, Wilcox WR. Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease. J Med Genet. 2015 May;52(5):353-8. doi: 10.1136/jmedgenet-2014-102797. Epub 2015 Mar 20.

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

repository_institution: University of California - eScholarship University of California

location_country:
Peru
Finland
Malaysia
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
Croatia
France
Japan
Lithuania
Kuwait
Norway
Poland
Argentina
Slovakia
Thailand
Indonesia
Canada
Slovenia
Korea, Republic of
Colombia
Chile
Sweden
United Arab Emirates
Saudi Arabia
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Czechia
Spain
Estonia

location_facility:
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Investigational Site Number :TBC
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title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation

summary: To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

ReferenceCitation: Ericzon BG, Varo E, Trunečka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.

name: Division of Transplantation Surgery; Karolinska University Hospital Huddinge; Stockholm Sweden

family: Ericzon

full_name: Bo-Göran Ericzon

given: Bo-Göran

name: Liver Transplant Unit; University Hospital Santiago de Compostela; Santiago de Compostela Spain

family: Varo

full_name: Evaristo Varo

given: Evaristo

name: Transplantcentre; Institute for Clinical and Experimental Medicine; Prague Czech Republic

family: Trunečka

full_name: Pavel Trunečka

given: Pavel

name: Department of Hepatobiliary and Transplant Surgery; University Medical Center; Hamburg-Eppendorf Germany

family: Fischer

full_name: Lutz Fischer

given: Lutz

name: Department of Surgery; Ospedale Giovanni XXIII; Bergamo Italy

family: Colledan

full_name: Michele Colledan

given: Michele

name: Division of Abdominal and Transplantation Surgery; ISMETT; Palermo Italy

family: Gridelli

full_name: Bruno Gridelli

given: Bruno

name: Liver Transplant Unit; Cruces University Hospital; Baracaldo-Bilbao Spain

family: Valdivieso

full_name: Andrés Valdivieso

given: Andrés

name: Liver Transplant Unit; King's College Hospital; London UK

family: O'Grady

full_name: John O'Grady

given: John

name: Clinical Services; NUVISAN GmbH; Neu-Ulm Germany

family: Dickinson

full_name: James Dickinson

given: James

name: Medical affairs; Astellas Pharma Europe Ltd; Chertsey UK

family: Undre

full_name: Nasrullah Undre

given: Nasrullah

journal_name: Clinical Transplantation

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

location_country:
Italy
Brazil
Sweden
Switzerland
United Kingdom
Germany
Finland
France
Poland
Norway
Ireland
Belgium
Australia
Spain
Canada
Czech Republic


title: The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
South Africa
Saudi Arabia
Netherlands
France
Belgium
Argentina
Spain
Korea, Republic of


title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

summary: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

location_country:
Brazil
United States
Peru
Sweden
Mexico
France
Argentina
Australia
Puerto Rico
Canada
United Kingdom
Korea, Republic of


title: A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

summary: Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.

ReferenceCitation: Montgomery S, Emir B, Haswell H, Prieto R. Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability. Curr Med Res Opin. 2013 Oct;29(10):1223-30. doi: 10.1185/03007995.2013.820694. Epub 2013 Aug 19.

name:
Imperial College School of Medicine, University of London
LondonUK

family: Montgomery

full_name: Stuart Montgomery

given: Stuart

name:
Pfizer Inc
New York, NYUSA

family: Emir

full_name: Birol Emir

given: Birol

name:
Pfizer Ltd
SurreyUK

family: Haswell

full_name: Hannah Haswell

given: Hannah

name:
Pfizer S.L.U., EuCan Medical Department
MadridSpain

family: Prieto

full_name: Rita Prieto

given: Rita

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country:
Italy
Austria
South Africa
United Kingdom
Netherlands
France
Poland
Israel
Belgium
Spain
Estonia
Germany
Latvia
Ukraine