title: A Two-Part, Randomized Phase III, Double-Blind, Multicenter Trial Assessing The Efficacy And Safety of Pertuzumab In Combination With Standard Chemotherapy Vs. Placebo Plus Standard Chemotherapy In Women With Recurrent Platinum-Resistant Epithelial Ovarian Cancer And Low HER3 mRNA Expression

summary: This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

ReferenceCitation: Lorusso D, Hilpert F, Gonzalez Martin A, Rau J, Ottevanger P, Greimel E, Luck HJ, Selle F, Colombo N, Kroep JR, Mirza MR, Berger R, Pardo B, Grischke EM, Berton-Rigaud D, Martinez-Garcia J, Vergote I, Redondo A, Cardona A, Bastiere-Truchot L, du Bois A, Kurzeder C; PENELOPE trial investigators. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1141-1147. doi: 10.1136/ijgc-2019-000370. Epub 2019 Aug 15.

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

location_country: Germany Italy Norway Denmark Sweden Netherlands Austria Belgium Spain France

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: A.O.Spedali Civili; Ostetricia e Ginecologia

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: Evangelischen Krankenhauses Düsseldorf; Frauenklinik

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: A.O.U Pisana; Dipartimento di Ginecologia Oncologica

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Academisch Ziekenhuis Leiden; Clinical Oncology

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik


study_start_date_type: Actual

intervention_type: Drug

acronym: Dynepo Infrequent Dosing Study

lead_sponsor: Shire

summary: The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

ReferenceType: derived

ReferenceCitation: Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.

location_facility: Clinique de Landy, Service de Nephrologie - Hemodialyse

location_facility: CHU Hopital Civil, Nephrologie-Hemodialyse

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie

location_facility: Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse

location_facility: Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe

location_facility: Azienda Ospedaliera Universitaria Policlinico di Modena

location_facility: Universita' degli Studi di Napoli Federico II

location_facility: Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich

location_facility: CH de Boulogne-sur-mer (Hopital de Dr Duchenne)

location_facility: Hellig Hart Ziekenhuis, Campus Wilgenstraat

location_facility: Richard Bright Renal Unit Southmead Hospital

location_facility: KfH Nierenzentrum am Handr-Klinikum Stralsund

location_facility: CHU - Hopital Pellegrin, Nephrologie-Hemodialyse

location_facility: UZ Gasthuisberg, Leuve, Dept of Nephrology

status: Terminated

title: An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
Spain
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Unknown


type: U.S. NIH Grant/Contract

title: Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial

acronym: OTPE

summary: The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.

status: Completed

primary_purpose: Health Services Research

ReferenceType: background

ReferenceCitation: Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz J, Roy PM, Fine MJ. Derivation and validation of a prognostic model for pulmonary embolism. Am J Respir Crit Care Med. 2005 Oct 15;172(8):1041-6. doi: 10.1164/rccm.200506-862OC. Epub 2005 Jul 14.

ReferenceCitation: Aujesky D, Roy PM, Le Manach CP, Verschuren F, Meyer G, Obrosky DS, Stone RA, Cornuz J, Fine MJ. Validation of a model to predict adverse outcomes in patients with pulmonary embolism. Eur Heart J. 2006 Feb;27(4):476-81. doi: 10.1093/eurheartj/ehi588. Epub 2005 Oct 5.

ReferenceCitation: Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.

lead_sponsor: University of Lausanne Hospitals

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

location_country:
United States
Switzerland
Belgium
France

location_facility: University Hospital Saint-Luc, Université Catholique de Louvain

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

summary: Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

ReferenceCitation: Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Finland
Germany
United Kingdom
Denmark
Sweden
Austria
Spain
Czech Republic
France


title: A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.

summary: The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

primary_purpose: Prevention

ReferenceCitation: Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.

lead_sponsor: Bayer

location_country:
France
Germany
Czech Republic

location_facility: Provozorna Gynekologicka ordinace Dr. Tesar

location_facility: Frauenarztpraxis Dipl. med. Michael Stellmacher


title: First in Man Study With MEN1112, a CD157 Targeted Monoclonal Antibody, in Relapsed or Refractory Acute Myeloid Leukemia.

acronym: ARMY

summary: The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and potential immunogenicity of MEN1112 will be evaluated as well.

lead_sponsor: Menarini Group

location_country: Germany Italy Belgium Spain France


title: A Parallel-Group, Randomized, Double-Blind, Multi-Center Dose Response Study To Evaluate The Efficacy And Safety Of PF-00885706, A 5-HT4 Receptor Partial Agonist, As Add-On Therapy To Esomeprazole For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) Who Have A Poor Response To Proton Pump Inhibitor (PPI) Treatment

summary: To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

lead_sponsor: Pfizer

location_country:
Germany
Slovakia
Brazil
Belgium
Korea, Republic of
Spain
France


title: Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

acronym: HomeCARE

summary: In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Ellery S, Pakrashi T, Paul V, Sack S. Predicting mortality and rehospitalization in heart failure patients with home monitoring--the Home CARE pilot study. Clin Res Cardiol. 2006;95 Suppl 3:III29-35. doi: 10.1007/s00392-006-1306-6.

ReferenceCitation: Sack S, Wende CM, Nagele H, Katz A, Bauer WR, Barr CS, Malinowski K, Schwacke H, Leyva F, Proff J, Berdyshev S, Paul V. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study. Eur J Heart Fail. 2011 Sep;13(9):1019-27. doi: 10.1093/eurjhf/hfr089.

lead_sponsor: Biotronik SE & Co. KG

location_country:
Germany
Italy
Israel
United Kingdom
Netherlands
Austria
Latvia
Spain
Czech Republic
France

location_facility: Gemeinschaftpraxis für Kardiologie und Angiologie

location_facility: Hadasit Medical Research Services & Development Ltd.

location_facility: CHRU Hôpital de Villeneuve, Cardiologie B

location_facility: P. Stradina Clinical University Hospital

location_facility: Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo

location_facility: CHRU Hôpital de Villeneuve, Cardiologie A

location_facility: Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski

location_facility: Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm

location_facility: Centre Hospitalier Universitaire d'Angers

intervention_type: Device


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.

location_facility: Centrum Onkologii Instytut im.Marii Sklodowskiej Curie

location_facility: Fondazione Policlinico Tor Vergata-UOC Patologie Linfoproliferative

location_facility: Dipartimento di Ematologia ed Oncoematolgia - S.C Ematolgia

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Hospital General Universiario Gregorio Maranon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Centre Hospitalier Universaitaire de Poit iers-Pole Regional de Cancerlogie

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

location_facility: Hospital Genereal Universitario Morales Meseguer

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: A.S.U. Integrata Santa Maria della Misericordia

location_facility: Azienda Unita Sanitaria Locale di Ravenna, U.O di Ematologia

location_facility: Institut Catala d'Oncologia Hospital Universitari de Bellvitge

location_facility: Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Dipartimento di Oncologia Medica

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: SCDU Ematologia e Terapie Cellulari Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Fakulni newmcince v Motole, Onkologicka klinika 2. LF UK a FN Motol

location_facility: Azienda Ospedaliera Vito Fazzi Unita Operativa di Ematologia

location_facility: Centre Hospitalier d'Avignon-Hopital Henri Duffaut

location_facility: Ospedale Policlinico San Martino IRCCS-Clinica Ematologica

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Azienda Ospedaliera Cardinale G Panico di Tricase-Unita Operativa Complessa di Ematologia e TMO

location_facility: Klinika Hematologii Nowotworow Kriwi i Transplantacji Szpiku

location_facility: Centro Integral Oncologico Clara Campal (CIOCC)

location_facility: Centre Hospitalier de Tours-Hopital Bretoneau Centre Regional de Cancerologie Henry Kaplan

location_facility: Wojewodzki Szpital Specjalistyczny w Legniicy

location_facility: London North West University Healthcare NHS Trust

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Torbay and South Devon NHS Foundation Trust

title: Dose Optimization Study of Idelalisib in Follicular Lymphoma

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

location_country:
France
Italy
Poland
United Kingdom
Romania
Australia
Spain
Czechia
Canada
Israel

ipd_sharing: Yes


title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

acronym: OPTI-MIND 2

summary: The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Slovakia
United Kingdom
Denmark
Netherlands
Belgium
Spain
France

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

location_facility: Service de cardiologie, CHU Nancy-Brabois

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: The National Institute of Cardiovascular Diseases

location_facility: Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO


title: Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy

acronym: PRINT

summary:
Study Design & Objectives:

Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.

To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.

Ancillary study objective:

To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.

time_perspective: Cross-Sectional

lead_sponsor: TcLand Expression S.A.

sponsor_collaborators:
TcLand Expression S.A.
Premier Research Group plc
Theradis pharma
Medpharmgene, Inc.

location_country: Lithuania Italy Slovakia Hungary Romania Spain Canada France

location_facility:
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title: A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II

summary: This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

location_country:
Germany
Italy
Netherlands
Belgium
Spain
South Africa
France


title: A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients

summary: A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Astellas Pharma Europe B.V.

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Czech Republic
France


title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

summary: The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

ReferenceCitation: Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756. Erratum In: J Clin Psychiatry. 2009 Dec;70(12):1729.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Germany
Italy
Sweden
United States
Russian Federation
France

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


title: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients

acronym: COPERNIC

summary:
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician.

Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Jules Bordet Institute

sponsor_collaborators:
Jules Bordet Institute
Hoffmann-La Roche

location_country: Belgium France

location_facility: Hopital Franco-Britannique - Fondation Cognacq-Jay

status_simplified: Ongoing


title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

summary: The drug investigated in the study is an antibody, GEN1047. Since this is the first study of GEN1047 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1047 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1047. GEN1047 will be studied in a broad group of cancer participants, having different kinds of solid tumors. All participants will get GEN1047. The study consists of two parts: Part 1 tests increasing doses of GEN1047 ("escalation"), followed by Part 2 ("expansion") which tests the recommended GEN1047 dose from Part 1.

ipd_sharing: No

lead_sponsor: Genmab

location_country:
Poland
United Kingdom
Denmark
Netherlands
United States
Spain
France

location_facility: Rigshospitalet (Copenhagen University Hospital)

location_facility: Hospital Clinico Universitario de Valencia

intervention_type: Biological


lead_sponsor: Janssen Sciences Ireland UC

summary: The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

location_facility: Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

title: A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

type: Other Identifier

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Italy
Poland
United Kingdom
Belgium
Spain
France


title: A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Innate Pharma

sponsor_collaborators:
Innate Pharma
AstraZeneca

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire- Hôpital Nord Laennec


title: TachoSil® Versus Current Practice in Dura Sealing Techniques for the Prevention of Post-operative Cerebrospinal Fluid (CSF) Leaks in Patients Undergoing Skull Base Surgery: An Open Label, Randomised, Controlled, Multi-centre, Parallel Group Efficacy and Safety Trial.

summary:
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.

The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.

lead_sponsor: Takeda

location_country:
Germany
Italy
Poland
Sweden
Netherlands
Austria
Belgium
Spain
Greece
Russian Federation
France

intervention_type: Procedure


title: Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative (ER, PR, Her2 Negative) Locally Advanced Non-resectable and/or Metastatic Breast Cancer

summary: The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast cancer

lead_sponsor: R-Pharm

location_country:
Italy
Poland
Austria
Spain
Greece
Czech Republic
France


title: A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin

summary: The purpose of this study is to investigate how efficient TMC435350 will work against the Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and what the concentrations of TMC435350 in the blood are with or without pegylated interferon alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.

ReferenceCitation: Lenz O, de Bruijne J, Vijgen L, Verbinnen T, Weegink C, Van Marck H, Vandenbroucke I, Peeters M, Simmen K, Fanning G, Verloes R, Picchio G, Reesink H. Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy. Gastroenterology. 2012 Nov;143(5):1176-1178.e6. doi: 10.1053/j.gastro.2012.07.117. Epub 2012 Aug 8.

ReferenceCitation: Manns M, Reesink H, Berg T, Dusheiko G, Flisiak R, Marcellin P, Moreno C, Lenz O, Meyvisch P, Peeters M, Sekar V, Simmen K, Verloes R. Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial. Antivir Ther. 2011;16(7):1021-33. doi: 10.3851/IMP1894.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
France


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
India
Belgium
China
Peru
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Pulmonary Specialists of the Palm Beaches

location_facility: Penn Medicine - Perelman Center for Advanced Medicine

location_facility: Oregon Health & Science University - Pulmonary Clinic

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: Coastal Pulmonary & Critical Care, P.L.C.

location_facility: Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building

location_facility: University of Cincinnati College Of Medicine

location_facility: University of California, San Francisco Medical Center- Pulmonary Practice

location_facility: Infectious Disease Associates Of NW Ohio Inc - Toledo

location_facility: Pulmonology, Sleep, Asthma & Allergy Center of Dublin

location_facility: The Ohio State University Wexner Medical Center

location_facility: (UPMC) - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD)

location_facility: Baylor University Medical Center At Dallas

location_facility: Vanderbilt Lung Institute - One Hundred Oaks

location_facility: NorthShore University HealthSystem - NorthShore Research Institute

location_facility: OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic

location_facility: Cleveland Clinic Florida-Maroone Cancer Center

location_facility: Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location

location_facility: Froedtert & the Medical College of Wisconsin Froedtert Hospital

location_facility: Medical University of South Carolina- College of Medicine

location_facility: AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine

location_facility: Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center

location_facility: Christiana Care Pulmonary Associates - Newark

location_facility: University of California UC Davis Medical Center

location_facility: Pulmonary and Sleep Associates of Jasper, P.C

location_facility: McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location

location_facility: Newark Beth Israel Medical Center (NBIMC) - Barnabas Health Lung Center

location_facility: Temple University Hospital (TUH) - Temple Lung Center (TLC)

location_facility: University of Maryland St. Joseph Medical Center

location_facility: The University of Texas Health San Antonio Medical Arts & Research Center

location_facility: Piedmont Healthcare - Piedmont Heart Institute

location_facility: University of Iowa Hospitals and Clinics

location_facility: Washington University School of Medicine in St. Louis

location_facility: University of Florida (UF) Health Shands Hospital

location_facility: University of Kansas Medical Center (KUMC)

location_facility: University of Texas Southwestern Medical Center - Pulmonary Specialty Clinic

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Bruce W. Carter Department of Veterans Affairs Medical Center

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Florida Lung, Asthma and Sleep Specialists - Celebration

location_facility: St Francis Sleep Allergy & Lung Institute

location_facility: University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic

location_facility: University of Colorado Anschutz Medical Campus - Department of Family Medicine

location_facility: Indiana University Health, Advanced Heart and Lung Care Center

location_facility: Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine


type: Registry Identifier

title: A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma

summary: This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Finland
Colombia
North Macedonia
New Zealand
Montenegro
Hungary
Romania
Australia
Brazil
Mexico
Korea, Republic of
Spain
South Africa
Croatia
Chile
Turkey
Canada
France

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

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: Cepen - Centro de Pesquisa E Ensino Em Oncologia de Santa Catarina

location_facility: Instituto Do Cancer de Sao Paulo - Icesp

location_facility: Centro de Atención E Investigación Clínica En Oncología

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Instituto Veracruzano En Investigacion Clinica S.C

location_facility: McGill University Jewish General Hospital

location_facility: Cdiem - Centro de Investigacion Y Especialidades Medicas

location_facility: Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr

location_facility: Fundacao Pio Xii Hospital de Cancer de Barretos

location_facility: Centro Estatal de Cancerologia de Chihuahua

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: University Hospital Centre Sestre Milosrdnice

location_facility: James Lind Centro de Investigacion Del Cancer

location_facility: University Clinic For Radiotherapy and Oncology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centrul de Oncologie Sf. Nectarie Craiova

location_facility: University of Pretoria Oncology Department

location_facility: Baskent University Adana Application and Research Center

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Hospital Regional Universitario de Malaga

location_facility: Oncosite - Centro de Pesquisa Clinica E Oncologia

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

location_facility: Hgb - Hospital Giovanni Battista - Mae de Deus Center

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Chu de Clermont - Ferrand- Hospital Estaing

location_facility: Centre Hospitalier de Pau - Hôpital François Mitterrand

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume


title: An 18-month Low-interventional Prospective, Multicentre Study to Assess Joint Outcomes in Patients With Haemophilia A or B on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa

acronym: JOIN-us

summary:
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc.

The main question it aims to answer is the:

• Evaluation of the overall joint status as detected by ultrasound in haemophilia A and B patients treated with rFVIIIFc or rFIXFc prophylaxis over the 18-month study period.

Participants will come to 6-monthly visits during the 18-month long study period and will perform an ultrasound with the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol at each visit. At baseline and end of study visits, the patients will be assessed with the clinical scoring system Haemophilia Joint Health Score (HJHS) and complete patient questionnaires. Retrospective data from patient medical records will also be collected for at least 6 months before enrolment in the study.

primary_purpose: Other

lead_sponsor: Swedish Orphan Biovitrum

sponsor_collaborators:
Swedish Orphan Biovitrum
IQVIA Pvt. Ltd

location_country:
Ireland
Italy
Slovenia
Hungary
United Kingdom
Romania
Spain
Croatia
Czechia
Bulgaria
France

location_facility:
Study site 124
Study site 130
Study site 145
Study site 153
Study site 100
Study site 131
Study site 137
Study site 136
Study site 114
Study site 134
Study site 138
Study site 117
Study site 101
Study site 119
Study site 128
Study site 140
Study site 157
Study site 129
Study site 110
Study site 133
Study site 141
Study site 108
Study site 102
Study site 111
Study site 143
Study site 158
Study site 147
Study site 103
Study site 120
Study site 121
Study site 118
Study site 109
Study site 112
Study site 152
Study site 149
Study site 154
Study site 123
Study site 125
Sudy site 122
Study site 150
Study site 106
Study site 107
Study site 132
Study site 155
Study site 139
Study site 115
Study site 156
Study site 142
Study site 105
Study site 126
Study site 146
Study site 151
Study site 104
Study site 113
Study site 135
Study site 159


title: A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

summary: The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

ipd_sharing_description:
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Romania
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Augusta University - Georgia Cancer Center

location_facility: University of Michigan - Rogel Cancer Center

location_facility: University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

location_facility: Hattiesburg Clinic - Hematology & Oncology

location_facility: The University of Chicago Medical Center - Duchossois Center for Advanced Medicine

location_facility: Mayo Clinic - Transplant Center - Rochester

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

location_facility: Woodlands Medical Specialists - Pensacola

location_facility: Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit

location_facility: Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center

location_facility: UT Southwestern-Harold C. Simmons Cancer Center

location_facility: Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola

location_facility: Columbia University Medical Center - Herbert Irving Pavilion Location

location_facility: Tennessee Oncology - Chattanooga Oncology & Hematology Associates

location_facility: St. John Hospital and Medical Center - Van Elslander Cancer Center

location_facility: Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd

location_facility: Novant Health Cancer Institute Hematology - Forsyth

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: Maryland Oncology Hematology, PA- Clinton

location_facility: Cancer & Hematology Centers of Western Michigan (CHCWM)

location_facility: The Winship Cancer Institute of Emory University

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Midwest Oncology Associates - Kansas City

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Novant Health Cancer Institute - Elizabeth

location_facility: Wenzhou Medical University - The First Affiliated Hospital

location_facility: University of Pittsburgh - Hillman Cancer Center

location_facility: University Hospital and UW Health Clinics


title: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer

summary: This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
Serbia
France
Colombia
Portugal
Hungary
United States
India
Romania
Belgium
China
Malaysia
Peru
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Israel


title: A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)

summary: CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Croatia
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
India
Romania
China
Malaysia
Estonia
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Bulgaria
Israel


title: A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

acronym: ROCKET-SHUTTLE

summary:
The coprimary objectives of the study are to:

evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Canada
France
Slovenia
Slovakia
Hungary
Switzerland
United States
Romania
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
Spain
Greece
Bulgaria

location_facility: Cinme - Centro de Investigaciones Metabolicas

location_facility: Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD

location_facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Dermatology Hospital of Jiangxi Province

location_facility: Atlanta Dermatology, Vein and Research Center, PC

location_facility: Industrial Medicine Associates Clinical Research Advanced Dermatology Care

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz

location_facility: Dermatology Hospital of Southern Medical University

location_facility: Universitaetsmedizin Goettingen - Georg-August-Universitaet

location_facility: GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

location_facility: Universitaire Ziekenhuizen Leuven Gasthuisberg

location_facility: Union Hospital Tongji Medical College Huazhong University of science and Technology

location_facility: Virginia Dermatology and Skin Cancer Center

location_facility: CARE- Centro de Alergia y Enfermedades Respiratorias

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Diagnostic-Consultative Center Alexandrovska EOOD

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

location_facility: Dermapolis Medical Dermatology Center dr n med Edyta Gebska

location_facility: Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"

location_facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna

location_facility: Keck Medicine of University of Southern California

location_facility: Medical Corporation Kojinkai Sapporo Skin Clinic

location_facility: Albuquerque Clinical Trials Incorporated

location_facility: Laser Rejuvenation Clinics Edmonton D.T. Incorporated

location_facility: Hospital General Universitario de Valencia

location_facility: Ippokratio General Hospital of Thessaloniki

location_facility: General Hospital Of Nea Ionia Konstantopouleio Patision

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Dermatology and Skin Cancer Center Leawood

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Kaiser Permanente Medical Center - San Francisco

location_facility: Centre Hospitalier de Bretagne Sud - Hopital du Scorff

location_facility: Hopital d instruction des armees sainte anne

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Schweiger Dermatology Group, PC Research Division

location_facility: Kaiser Permanente South Sacramento Medical Center

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

location_facility: University of California at Davis Medical Center

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: Marmara Universitesi Tip Fakultesi Hastanesi

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Royal United Hospitals Bath NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: University General Hospital of Heraklion

location_facility: Dermatology Research Institute Incorporated

location_facility: Andreas Syngros Hospital Of Venereal And Dermatological Diseases

location_facility: Fakultna nemocnica s poliklinikou JA Reimana Presov

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine

location_facility: Kaiser Permanente Medical Center - Oakland

location_facility: Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Centre Hospitalier Universitaire Archet 2

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende

location_facility: Psoriahue Medicina Interdisciplinaria SRL


title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

acronym: LIBREXIA-STROK

summary: The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Bristol Myers Squibb Company (BMS)

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Croatia
Chile
Czechia
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Romania
Belgium
China
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location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Hospital Interzonal General de Agudos Eva Perón

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Oddzial Ortopedii i Traumatologii Narzadu Ruchu Szpital Specjalistyczny im. Ludwika Rydygiera

location_facility: Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu'

location_facility: Associacao Educadora Sao Carlos AESC Hospital Mae De Deus

location_facility: Houston Methodist Neurological Institute

location_facility: Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny w Chelmie

location_facility: Nemocnica s poliklinikou Spisska Nova Ves, a.s.

location_facility: Azienda Unita Sanitaria Locale Umbria 1 Ospedale di Citta di Castello

location_facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V.

location_facility: Multiprofile Hospital for Active Treatment Puls

location_facility: Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose

location_facility: Bhaktivedanta Hospital & Research Institute

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Multiprofile Hospital for Active Treatment - Sofia

location_facility: III Szpital Miejski im. Dr. K. Jonschera w Lodzi

location_facility: Kyoyukai Sainokuni Higashiomiya Medical Center

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

location_facility: Centro Hospitalar e Universitário de Coimbra - Hospitais da Universidade de Coimbra

location_facility: Szpital Specjalistyczny im. F. Ceynowy Szpitale Pomorskie

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Emergency Clinical County Hospital Constanta

location_facility: Saint Alphonsus Regional Medical Center- Cancer Care Center

location_facility: SP Specjalistyczny Szpital Zachodni im. Jana Pawla II

location_facility: Community Hospital Cardiovascular Research

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital Specjalistyczny nr 3 w Rybniku

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Groupe Hospitalier Pellegrin CHU de Bordeaux

location_facility: Prairie Education And Research Cooperative

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Insight Hospital and Medical Center Chicago

location_facility: Spitalul Clinic Judetean de Urgenta Arad

location_facility: Spitalul de Psihiatrie si Neurologie Brasov

location_facility: Seoul National University Boramae Hospital

location_facility: Memorial Institute for Neurosciences and Multiple Sclerosis

location_facility: KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)

location_facility: Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

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

location_facility: Specjalistyczny Szpital Miejski im. M.Kopernika

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution

location_facility: Shree Krishna Hospital and Medical Research Center

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Multiprofile Hospital for Active Treatment - Haskovo

location_facility: University of Kansas Medical Center Research Institute

location_facility: Severance Hospital Yonsei University Health System

location_facility: Synergy Biomed Research Institute (SBRI)

location_facility: Clinica Neurologica e Neurocirurgica de Joinville

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: Fakultna nemocnica s poliklinikou v Ziline

location_facility: Royal Devon and Exeter Hospital(Wonford)

location_facility: Saitama Medical University International Medical Center

location_facility: Azienda sanitaria universitaria Giuliano Isontina ASU GI

location_facility: 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

location_facility: Institutul National de Neurologie si Boli Neurovasculare Bucuresti

location_facility: Centre Hospitalier du Pays d'Aix Service de Neurologie

location_facility: Zespol Opieki Zdrowotnej w Skarzysku-Kamiennej Szpital Powiatowy im. M.Curie-Sklodowskiej

location_facility: ASUI Santa Maria della Misericordia di Udine

location_facility: Centro Hospitalar de Lisboa Norte Hospital Santa Maria

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital Central

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Wojewodzki Szpital Zespolony w Lesznie Oddzial Neurologiczny z Pododzialem udarowym

location_facility: Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej Medicam Gryfice

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Fondation Adolphe de Rothschild Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centre Hospitalier EPICURA Ath-Baudour-Hornu

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Tokushukai Matsubara Tokushukai Hospital

location_facility: Debreceni Egyetem Klinikai Központ,Infektológiai Klinika

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Klinikum der Johann Wolfgang Goethe -Universitaet

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Guangdong Second Provincial General Hospital

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Affiliated Hospital Of Guangdong Medical University

location_facility: Chang Gung Memorial Hospital, Chiayi Branch

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera della Provincia di Lecco_Presidio Ospedaliero 'A. Manzoni' - S.C.di Cardiologia

location_facility: Seoul National University Bundang Hospital

location_facility: Pinderfields General Hospital - Dept. of Neurology

location_facility: Hospital Municipal Dr Raul Alfredo Caccavo

location_facility: Arcispedale S Maria Nuova (Civic Hospital)

location_facility: National Hospital Organization Fukuoka Higashi Medical Center

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: Ascension Medical Group - St. John Clinic Infectious Disease

location_facility: National Cerebral and Cardiovascular Center


acronym: OCEANIC-STROKE

lead_sponsor: Bayer

summary:
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had:

an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or
TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together.

Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting).

The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding.

The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health.

Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months.

Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned.

During the study, the study team will:

Check vital signs such as blood pressure and heart rate
Examine the participants' heart health using an electrocardiogram (ECG)
Take blood samples
Ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

location_facility: Hospital Sultanah Nur Zahirah Medical Department

location_facility: Sree Chitra Tirunal Institute for Medical Sciences and Technology

location_facility: Instytut Psychiatrii i Neurologii w Warszawie

location_facility: CIUSSS de l'Estrie-CHUS, Hopital Fleurimont

location_facility: University of Southern California Keck School of Medicine

location_facility: Prisma Health Greenville Memorial Hospital

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Catalan Health Institute | Hospital Universitario de Girona Doctor Josep Trueta - Neurology Department, Stroke Unit

location_facility: Sanatorio Allende | Departamento de Investigación Clínica

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Fakultni nemocnice Kralovske Vinohrady - Neurologicka klinika

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke

location_facility: The First Affiliated Hospital of Jinzhou Medical University

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi

location_facility: Wojew. Szpital Specjalistyczny im. M. Kopernika

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Western Health Neuroscience Research Unit

location_facility: COMPLEJO HOSPITALARIO RUBER JUAN BRAVO - Neurología

location_facility: Cottage Health I Santa Barbara Cottage Hospital - Research Department

location_facility: P. Stradins Clinical University Hospital

location_facility: Trinity Health | Oakland Hospital - Clinical Research Department

location_facility: Universitaetsklinikum St. Poelten | Abteilung für Neurologie

location_facility: Royal Derby Hospital Derby Teaching Hospitals NHS Foundation

location_facility: Hopital des Armees Sainte-Anne, Neurologie, Toulon

location_facility: HagaZiekenhuis | Department of Neurology

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Vancouver General Hospital / Vancouver Stroke Program

location_facility: Nemocnice AGEL Ostrava-Vítkovice - Neurologicke oddeleni

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Hospital Universitario Arnau de Vilanova de Lleida | Neurology Department - Clinical Neuroscience Research Group

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Health Sciences North Research Institute | Sudbury, Canada

location_facility: Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia

location_facility: Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

location_facility: Klinikum Altenburger Land / Studienzentrum Neurologie

location_facility: Sanatorio Parque | Departamento de Neurologia

location_facility: Fakultni nemocnice u sv. Anny - I.neurologicka klinika

location_facility: Christian Medical College & Hospital (CMCH) - Ludhiana

location_facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Oradea

location_facility: Universitätsklinikum Freiburg / Neurologie

location_facility: San Bernardo Hospital | Neurology Department

location_facility: The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...

location_facility: University of Pittsburgh Medical Center Hamot

location_facility: Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara

location_facility: Istanbul Sultan 2. Abdulhamid Han Egitim ve Arastirma Has.

location_facility: Barmherzige Brueder Wien | Abt. fuer Neurologie

location_facility: Nemocnice Pardubickeho Kraje, as - Neurologická klinika

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Nova Clinical Research | Manatee Memorial Hospital

location_facility: Hospital Garcia de Orta | Research Department

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Intercoastal Medical Group | Clinical Research

location_facility: Nemocnice Jihlava - Neurologicke oddeleni

location_facility: Hospital Moinhos de Vento-Centro Clínico

location_facility: Klinik Ottakring | Neurologische Abteilung

location_facility: Hospital Italiano de La Plata | Clinical Research Department

location_facility: OLVG | Location West - Neurology Department

location_facility: Vseobecna nemocnica s poliklinikou Levoca, a.s.

location_facility: Hospital Pengajar Universiti Putra Malaysia

location_facility: Hôpital Cantonal Universitaire de Genève

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: All India Institute of Medical Sciences (AIIMS) - New Delhi

location_facility: Universität Gießen-Marburg, Standort Gießen/Neurologie

location_facility: General Hospital of Ningxia Medical University

location_facility: Fakultni Thomayerova Nemocnice - neurology department

location_facility: University of Mississippi Medical Center | Shafi Group

location_facility: Wake Forest University School of Medicine

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Alfried Krupp Krankenhaus Rüttenscheid /Neurologie

location_facility: Hospital Estadual Central Vitoria - Fundação INOVA - ES

location_facility: Lewis Katz School of Medicine at Temple University - Neurolo

location_facility: Hospital Rey Juan Carlos | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Masaryk Hospital Usti n/L - neurology department

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Clinical Emergency County Hospital Brasov

location_facility: National Taiwan University Hospital, Hsin-Chu Branch

location_facility: The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke Program

location_facility: Med Campus III | Klinik fuer Neurologie 2

location_facility: Eastern Shore Research Institute, LLC | Fairhope, AL

location_facility: The Affiliated Huaian No.1 People's Hospi of NJ Medical Unv.

location_facility: MHAT Haskovo AD | Department of Nervous Diseases

location_facility: Universitaetsklinikum Heidelberg / Neurologie

location_facility: PAPANIKOLAOU General Hospital Thessaloniki

location_facility: Hospital Universitario Professor Edgard Santos

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Zhujiang Hospital of Southern Medical University

location_facility: Hospital General de Agudos JM Ramos Mejía

location_facility: Intermountain Healthcare | Cardiovascular Research Department

location_facility: Nova Clinical Research | Blake Medical Center Center

location_facility: Acibadem City Clinic | Tokuda Hospital - Department of Neurology and Sleep Medicine

location_facility: Keimyung University Dongsan Medical Center

location_facility: Emergency Care Hospital of Aktobe City - Stroke Unit

location_facility: Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni

location_facility: Kent and Canterbury Hospital | Stroke Unit

location_facility: Bispebjerg Hospital, Neurologisk Afdeling

location_facility: Spitatul Universitar de Urgenta Bucuresti

location_facility: Regionshospitalet Gødstrup, Neurologisk Afd.

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Saskatchewan, Royal University Hospital

location_facility: The Second Affiliated Hospital of Nanjing Medical university

location_facility: General Hospital of Athens "Evangelismos"

location_facility: Nemocnice na Homolce - Neurology Department

location_facility: Froedtert Health/Medical College of Wisconsin

location_facility: Hwa Mei Hospital, University of Chinese Academy Sciences

location_facility: Ohio State University Wexner Medical Center

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Med

location_facility: Hospital Universitario La Paz | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Servicios de Salud Universidad de Antioquia

location_facility: Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: Mazda Hospital of Mazda Motor Corporation

location_facility: Hospital General de Agudos Dr. Ignacio Pirovano

location_facility: 1st Affiliated Hospital of Nanhua University

location_facility: Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach

location_facility: Mercyhealth Javon Bea Hospital - Riverside | Neurology Research Department

location_facility: The First Affiliated Hospital of Baotou Medical College

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: Hoag Memorial Hospital - Center for Research & Education

location_facility: Ochsner Health System | Ochsner Clinic Foundation - Neuroscience Research Department

location_facility: Promotora Médica Las Américas S.A.- Clinica Las Americas

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

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

location_facility: University of Semmelweis/ Semmelweis Egyetem

location_facility: Universitätsklinikum Düsseldorf / Neurologie

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho

location_facility: Hospital Universitario Clinico de Valladolid | Neurology Department

location_facility: St. Joseph's Hosp | Barrow Neuro Institute

location_facility: A.O. Ospedali Riuniti Villa Sofia-Cervello

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: BayCare Health System | Morton Plant Hospital, Neuroscience Research department

location_facility: Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital

location_facility: Hospital das Clinicas da Universidade Federal do Paraná

location_facility: University of Calgary | Foothills Medical Centre - Department of Clinical Neurosciences - Stroke Clinical Trials Group

location_facility: Universitätsklinikum Mannheim / Neurologie

location_facility: Fundação Facu. Reg de Medicina de São José do Rio Preto

location_facility: King's College Hospital - NHS Foundation Trust

location_facility: University General Hospital of Alexandroupolis

location_facility: Okayama City General Medical Center Okayama City Hospital

location_facility: Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"

location_facility: Kaiser Permanente Fontana Medical Center

location_facility: Hospital das Clínicas de Botucatu - UNESP Botucatu

location_facility: General Hosp of Athens "Korgialenio-Benakeio" RCH

location_facility: Multiprofile Hospital for Active Treatment National Cardiology Hospital | Clinic for Neurological Diseases

location_facility: La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi

location_facility: Mercy Health St. Elizabeth Youngstown Hospital

location_facility: University of Illinois at Chicago | Department of Neurology

location_facility: Universitätsklinikum Frankfurt / Neurologie

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: Vseobecna nemocnica s poliklinikou Lucenec

location_facility: Cardiology Associates of Fairfield County, PC - Trumbull

location_facility: Fakultni nemocnice Ostrava - Neurologicka klinika

location_facility: Barzilai Medical Center | Neurology Department

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: General Hospital of Northern Theater Command

location_facility: University Multispecialty Hosp Dep General&Vascu Neurology

location_facility: Kingston Health Sciences Centre (KGH Site)

location_facility: Wojewodzki Szpital Specjalistyczny im. sw. Jadwigi w Opolu

location_facility: Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

location_facility: University of Texas Southwestern Medical Center

location_facility: City Clinical Hospital No7 - Stroke Unit

location_facility: National Institute of Mental Health and Neurosciences (NIMHANS)

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: The Third Affiliated Hospital of Xinxiang Medical university

location_facility: Hosp Univ Virgen Macarena|Neurologia|Neurovascular Res Unit

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: Inspira Medical Centers | Clinical Research Office

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Univerzitna nemocnica Bratislava, Nemocnica ak. L.Derera

location_facility: Fundación Hospital Universidad del Norte

location_facility: Glasgow Royal Infirmary | Glasgow Clinical Research Facility

location_facility: Sawami Man Singh (SMS) Medical College & Attached Hospitals

location_facility: University of Florida Health Sciences Center

location_facility: University of California Davis Medical Center

location_facility: Rhön-Klinikum Campus Bad Neustadt/Neurologie

location_facility: ProMedica | ProMedica Toledo Hospital - Neuro/Stroke Research Department

location_facility: National Hospital Organization Ureshino Medical Center

location_facility: Sørlandet Sykehus Kristiansand Nevrologisk avdeling

location_facility: Szpital Wolski im. dr Anny Gostynskiej SPZOZ

location_facility: Japanese Red Cross Society Suwa Hospital

location_facility: Kettering Health Network | Research Institute

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: University Hospital of A Coruna | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: CHUM - Centre hospitalier de l'Université de Montréal

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Centre Hospitalier Universitaire - Le Kremlin Bicêtre

location_facility: Institutul National de Neurologie ¿i Boli Neurovasculare

location_facility: Hospital de Vila Franca de Xira | Centro de Desenvolvimento e Investigacao

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

location_facility: Städtisches Klinikum Dresden / Neurologie

location_facility: CHUC - Hospitais da U. Coimbra - Servico de Neurologia

location_facility: 1st Affiliated Hospital of Henan Science and Technology Univ

location_facility: Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Valley Baptist Health System | Harlingen - Clinical Research

location_facility: Trinity Medical Western New York | Trinity Vascular & Endovascular Center - Research Department

location_facility: Yale University | School of Medicine - Department of Neurology

location_facility: Unity Health Toronto | St. Michael's Hospital - Stroke Research

location_facility: Hôpital Guillaume et René Laennec - Nantes

location_facility: Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves

location_facility: ASL1 Avezzano-Sulmona-L'Aquila - Abruzzo

location_facility: Karvinska hornicka nemocnice a.s. - Neurologicke oddeleni

location_facility: Hôpital La Cavale Blanche - CHU de Brest

location_facility: Krajska nemocnice Liberec - neurologicke oddeleni

location_facility: Hospital Professor Doutor Fernando Fonseca | Neurology Department

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: AZ Groeninge Campus Kennedylaan - Neurology department

location_facility: Policlinico Lomas | Neurology Department

location_facility: Szpital Uniwersytecki Nr 2 im. J. Bizela

location_facility: Complejo Asistencial Universitario de Leon | Neurology Division - Stroke Unit

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Saglik Bilimleri Universitesi Izmir Tepecik EAH

location_facility: UMHAT Tsaritsa Yoanna-ISUL Clinic for neurology diseases

location_facility: Medizinische Universitaet Innsbruck | Neurologie

location_facility: Hiroshima City North Medical Center Asa Citizens Hospital

location_facility: Affiliated Hospital of Jining Medical University

location_facility: The Hospitals of the University of Pennsylvania

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Hopital Saint Philibert - Service de Neurologie

location_facility: Hospital Privado de Rosario (HPR Grupo Gamma)

location_facility: Vivantes Klinikum Neukölln / Neurologie mit Stroke Unit

location_facility: Wright State University | Boonshoft School of Medicine - WSU and Premier Health Clinical Trials Research Alliance

location_facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Nemocnice Ceske Budejovice, a.s. - Department of neurology

location_facility: University Multiprof. Hosp. for Active Treatment Pulmed

location_facility: Xuanwu Hospital Capital Medical University

location_facility: The Third Hospital of Hebei Medical University

location_facility: Catharina Hospital | Neurology Outpatient Clinic

location_facility: Baylor University Medical Center at Dallas

location_facility: Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Christian Medical College & Hospital (CMCH) - Vellore

location_facility: University Multi-profile Hospital for Active Treatment and Emergency Medicine Pirogov | Department of Nervous Diseases

location_facility: South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department

location_facility: BlueClinical | Centro Hospitalar Baixo Vouga - Unidade Aveiro - Gabinete de Ensaios Clinicos

location_facility: Universitaetsklinikum Graz | Abteilung für Neurologie

location_facility: ProCare Svet Zdravia | Rimavska Sobota Hospital - Neurology Department

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: China Medical University Hospital Hsin-Chu Branch

location_facility: Virgen del Rocio Univ Hosp | Neur Dep | Neurovascular Unit

location_facility: Hospital Universitario de La Princesa | Neurology Department

location_facility: Health Corporation of the Ziv Medical Center (R.A.)

location_facility: Hospital Alvaro Cunqueiro | Neurology - Stroke, No-Cardioembolic-Tia

location_facility: Maasstad Ziekenhuis | Neurology Department

location_facility: St. Antonius Hospital | Nieuwegein - Neurology Department - Stroke Unit

location_facility: Hospital Privado de Comunidad | Clinical Research Department

location_facility: Universitaeres Landeskrankenhaus Feldkirch | Neurologie

location_facility: Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department

location_facility: Akershus Universitetssykehus - Nevrologisk Avdeling

location_facility: Clinica Neurologica e Neurocirurgica de Joinville Ltda

location_facility: Turkestan Regional Clinical Hospital - Stroke Unit

location_facility: Affiliated Hospital of Yangzhou University

location_facility: Hoital Bichat, Service de Neurologie, Paris

location_facility: Odense Universitetshospital, Dept of Neurology

location_facility: University General Hospital of Heraklion

location_facility: National Hospital Organization Toyohashi Medical Center

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures

location_facility: Bakirkoy Prof Dr Mazhar Osman Ruh Sagligi ve Sinir Hast. EAH

location_facility: Banner - University Medical Center Tucson

location_facility: ProCare Svet Zdravia | Vranov nad Toplou Hospital - Neurology Department

location_facility: University Medical Center (UMC) Utrecht | Neurology and Neurosurgery Department

location_facility: Landesklinikum Moedling | Abteilung für Neurologie

location_facility: Hospital da Universidade Federal de Minas Gerais

location_facility: Marmara Uni. Tip Fak. Pendik EAH Noroloji

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Minneapolis Clinic of Neurology | Golden Valley, MN

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

location_facility: UMHAT Dr Georgi Stranski Pleven | Department of Neurology

location_facility: G. GENNIMATAS General State Hospital of Athens

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Haukeland Universitetssykehus Nevrologisk Avdeling

location_facility: University of Texas Health Science Center at Houston

location_facility: SP Szpital Kliniczny nr 1 PUM im. Prof. T. Sokolowskiego

location_facility: Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: A.O.U. San Giovanni di Dio Ruggi d'Aragona

title: A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Kazakhstan
Turkey
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
India
Romania
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel