title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

summary: This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

primary_purpose: Prevention

ReferenceCitation: Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.

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

location_country:
Germany
Ireland
Hungary
Hong Kong
United Kingdom
United States
Thailand
Pakistan
Canada
Philippines
France


title: An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)

acronym: SILVER

summary:
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.

ReferenceCitation: Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.

lead_sponsor: AstraZeneca

location_country:
Finland
France
Germany
Slovakia
Norway
Argentina
Denmark
Romania
Sweden
Mexico
Spain
South Africa
Bulgaria
Canada
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

summary: The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992 Jun;14(4):309-17. doi: 10.1097/00004836-199206000-00009.

ReferenceCitation: Hugot JP, Chamaillard M, Zouali H, Lesage S, Cezard JP, Belaiche J, Almer S, Tysk C, O'Morain CA, Gassull M, Binder V, Finkel Y, Cortot A, Modigliani R, Laurent-Puig P, Gower-Rousseau C, Macry J, Colombel JF, Sahbatou M, Thomas G. Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):599-603. doi: 10.1038/35079107.

ReferenceCitation: Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nunez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6. doi: 10.1038/35079114.

ReferenceCitation: Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.

ReferenceCitation: Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.

ReferenceCitation: Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.

ReferenceCitation: Farmer RG, Hawk WA, Turnbull RB Jr. Clinical patterns in Crohn's disease: a statistical study of 615 cases. Gastroenterology. 1975 Apr;68(4 Pt 1):627-35. No abstract available.

ReferenceCitation: Gray BK, Lockhartmummery HE, Morson BC. Crohn's disease of the anal region. Gut. 1965 Dec;6(6):515-24. doi: 10.1136/gut.6.6.515. No abstract available.

ReferenceCitation: Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. doi: 10.7326/0003-4819-135-10-200111200-00011.

ReferenceCitation: Schwartz DA, Herdman CR. Review article: The medical treatment of Crohn's perianal fistulas. Aliment Pharmacol Ther. 2004 May 1;19(9):953-67. doi: 10.1111/j.1365-2036.2004.01917.x.

ReferenceCitation: Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.

ReferenceCitation: Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. doi: 10.1056/NEJM198005013021801.

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.

ReferenceCitation: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.

lead_sponsor: Ocera Therapeutics

location_country:
France
Germany
Poland
Hungary
Israel
United Kingdom
Netherlands
Austria
Belgium
United States
Canada
Czech Republic

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Zakaznych Szpitala Uniwersyteckiego w Krakowie

location_facility: CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif

location_facility: The Penn State University, Milton S. Hershey Medical Center

location_facility: Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora

location_facility: Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM

location_facility: Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie

location_facility: Universitatsklinik fur Innere Medizin I der PMU

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: University Hospital Olomouc, 2nd Internal Department

location_facility: John Radcliffe Hospital, Dept. of Gastroenterology

location_facility: Univ Klinik fur Innere Medizin Innsbruck

location_facility: University College London Hospital, Dept. of Gastroenterology

location_facility: Bristol Royal Infirmary, Dept. of Gastroenterology

location_facility: University Hospital Prague 2, 4th Department of Internal Medicine

location_facility: Erasmus MC, Department of Gastroenterology and Hepatology

location_facility: Hopital Claude Huriez, Service des maladies de l'appareil disgestif

location_facility: University of Louisville, Department of Surgery

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet

location_facility: Rabin Medical Center, Bellinson Hospital

location_facility: University Hospital Gasthuisberg, University of Leuven

location_facility: University Hospital Brno, Internal and Gastroenterology Department

location_facility: Hopital Nord, Service de Gastro-Enterologie

location_facility: Universitat Rostock - Midizinische Fakultat

location_facility: Metropolitan Gastroenterology Group/Chevy Chase Clinical Research

location_facility: Thomayer's University Hospital Prague, 2nd Internal Department

location_facility: Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu

location_facility: Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation

location_facility: Leicester General Hospital - GI Research Unit

location_facility: Korektalnej Uniwersytetu Medycznego w Lodzi

location_facility: Indiana University, Outpatient Clinical Research Facility

location_facility: Cleveland Clinic - Department of Gastroenterology

location_facility: Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA

location_facility: CHU Hopital Nord, Service de Gastro-enterologie et nutrition

location_facility: Mount Sinai School of Medicine, IBD Research Center

location_facility: Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet

location_facility: Regional Hospital Liberec, Department of Gastroenterology

location_facility: University of Kentucky Chandler Medical Center


type: EudraCT Number

title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

summary: This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

ReferenceType: result

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

ReferenceCitation: Marre M, Shaw J, Brandle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.

ReferenceCitation: Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.

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

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

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

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

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

ReferenceCitation: Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.

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

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

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

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

publisher_dissemination: Elsevier

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

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

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

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Croatia
France
Czech Republic
Switzerland
India
Romania
Malaysia
Philippines
Italy
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel


title: A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

acronym: RELAX

summary: The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

ReferenceCitation: Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.

location_country:
France
Germany
Italy
Poland
Portugal
Slovakia
Hungary
Argentina
Switzerland
Mexico
United States
Bulgaria
Canada
Czech Republic


title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

summary: Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

ipd_sharing: Yes

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
France


title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

summary: The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

ReferenceCitation: Fleischhacker WW, Heikkinen ME, Olie JP, Landsberg W, Dewaele P, McQuade RD, Loze JY, Hennicken D, Kerselaers W. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Int J Neuropsychopharmacol. 2010 Sep;13(8):1115-25. doi: 10.1017/S1461145710000490. Epub 2010 May 12.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Finland
Germany
Poland
Hungary
United Kingdom
Sweden
Switzerland
Austria
South Africa
Turkey
Czech Republic
France


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients

acronym: IMPACT

summary: This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

study_start_date_type: Actual

ReferenceCitation: Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Romania
Australia
Brazil
Belgium
United States
Spain
Canada
France

location_facility: Oregon Health Sciences Uni ; Division of Nephrology

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas

location_facility: Royal Prince Alfred Hospital; Renal Transplant Unit

location_facility: Hospital de Cruces; Servicio de Enfermedades Infecciosas

location_facility: Hospital Israelita Albert Einstein; Intensive Care Unit

location_facility: Hospital Universitario Dr. Peset; Servicio de Nefrologia

location_facility: Indiana Uni Medical Center; Surgery & Microbiology/Immunology

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie

location_facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

location_facility: Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Klinikum der Universitaet Regensburg; Nephrologie

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive

location_facility: Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii

location_facility: New England Medical Center; Division of Transplant Surgery

location_facility: Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur

location_facility: Auckland City Hospital; Renal Unit, Level 15

location_facility: Ucsd Medical Center; Kidney Transplantation

location_facility: Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: Uni of Texas Health Science Center At San Antonio; Organ Transplant Program

location_facility: Uni of Minnesota Medical Center; Dept of Surgery

location_facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Uni of Washington Medical Center; Division of Allergy & Infectious Diseases

location_facility: CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation

location_facility: Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse

location_facility: Hopital Bretonneau; Nephrologie Transplantations

location_facility: Robert Wood Johnson Uni Hospital; Anesthesia

location_facility: Royal Liverpool Uni Hospital; Renal Dept

location_facility: Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery

location_facility: Uni of California San Francisco; Transplant Services

location_facility: Nottingham City Hospital; Transplant Unit

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

location_facility: Churchill Hospital; Oxford Transplant Center Renal Transplant Unit

location_facility: Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj

location_facility: Institutul de Urologie Si Transplant Renal Fundeni

location_facility: Institutul de Urologie Si Transplant Renal Cluj Napoca

location_facility: Monash Medical Centre; Renal Transplant Unit

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

location_facility: Manchester Royal Infirmary; Renal Transplant Unit

location_facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

location_facility: Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program

location_facility: Wake Forest Uni School of Medicine; Section on Infectious Diseases

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I


title: A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

summary: E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).

ReferenceCitation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Cheng AL, Vogel A, Tovoli F, Ueshima K, Aikata H, Lopez CL, Pracht M, Meng Z, Daniele B, Park JW, Palmer D, Tamai T, Saito K, Dutcus CE, Lencioni R. Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study. J Hepatol. 2023 Jan;78(1):133-141. doi: 10.1016/j.jhep.2022.09.006. Epub 2022 Sep 20.

oa_host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: University of Cantabria - UCrea

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

unpaywall_oa_status: green

ReferenceCitation: Huynh J, Cho MT, Kim EJ, Ren M, Ramji Z, Vogel A. Lenvatinib in patients with unresectable hepatocellular carcinoma who progressed to Child-Pugh B liver function. Ther Adv Med Oncol. 2022 Aug 24;14:17588359221116608. doi: 10.1177/17588359221116608. eCollection 2022.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: gold

publisher_dissemination: SAGE Publications

ReferenceCitation: Vogel A, Qin S, Kudo M, Su Y, Hudgens S, Yamashita T, Yoon JH, Fartoux L, Simon K, Lopez C, Sung M, Mody K, Ohtsuka T, Tamai T, Bennett L, Meier G, Breder V. Lenvatinib versus sorafenib for first-line treatment of unresectable hepatocellular carcinoma: patient-reported outcomes from a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):649-658. doi: 10.1016/S2468-1253(21)00110-2. Epub 2021 Jun 2.

ReferenceCitation: Okusaka T, Ikeda K, Kudo M, Finn R, Qin S, Han KH, Cheng AL, Piscaglia F, Kobayashi M, Sung M, Chen M, Wyrwicz L, Yoon JH, Ren Z, Mody K, Dutcus C, Tamai T, Ren M, Hayato S, Kumada H. Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT. J Gastroenterol. 2021 Jun;56(6):570-580. doi: 10.1007/s00535-021-01785-0. Epub 2021 May 4.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Yonsei University Medical Library - YUHSpace

publisher_dissemination: Springer-Nature

ReferenceCitation: Briggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Yamashita T, Kudo M, Ikeda K, Izumi N, Tateishi R, Ikeda M, Aikata H, Kawaguchi Y, Wada Y, Numata K, Inaba Y, Kuromatsu R, Kobayashi M, Okusaka T, Tamai T, Kitamura C, Saito K, Haruna K, Okita K, Kumada H. REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset. J Gastroenterol. 2020 Jan;55(1):113-122. doi: 10.1007/s00535-019-01642-1. Epub 2019 Nov 12.

ReferenceCitation: Evans TRJ, Kudo M, Finn RS, Han KH, Cheng AL, Ikeda M, Kraljevic S, Ren M, Dutcus CE, Piscaglia F, Sung MW. Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma. Br J Cancer. 2019 Jul;121(3):218-221. doi: 10.1038/s41416-019-0506-6. Epub 2019 Jun 28. Erratum In: Br J Cancer. 2019 Jul 30;:

ReferenceCitation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

location_country:
Germany
Poland
Australia
Japan
Thailand
Canada
France
Hong Kong
United States
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility:
Facility # 6
Facility # 2
Facility # 4
Facility # 1
Facility # 3
Facility # 5
Facility # 8
Facility # 7


title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

ReferenceCitation: Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.

publisher_dissemination: British Medical Journal

ReferenceCitation: Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.

oa_colors: green other

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
Germany
Poland
Argentina
Australia
Canada
France
Slovakia
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel


title: FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.

acronym: FACT

summary: The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

location_country:
Finland
Germany
Italy
Guatemala
Portugal
Norway
Costa Rica
Sweden
Iceland
Turkey
Canada
France


title: A Phase 3, Multicenter, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Omiganan 1% Gel in Preventing Local Catheter Site Infections/Colonization in Patients Undergoing Central Venous Catheterization

summary: The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.

lead_sponsor: Cadence Pharmaceuticals

location_country:
United States
Spain
Germany
France


title: The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.

acronym: EXTEND

summary: This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.

status: Terminated

ReferenceCitation: Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.

location_country:
Finland
Germany
Poland
Portugal
Hungary
Norway
Denmark
Sweden
Netherlands
Austria
Belgium
Mexico
Switzerland
Spain
South Africa
France

status_simplified: Unknown


type: Other Identifier

title: Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.

summary:
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

design_allocation: Non-Randomized

ReferenceCitation: Edan G, Kappos L, Montalban X, Polman CH, Freedman MS, Hartung HP, Miller D, Barkhof F, Herrmann J, Lanius V, Stemper B, Pohl C, Sandbrink R, Pleimes D; BENEFIT Study Group. Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1183-9. doi: 10.1136/jnnp-2013-306222. Epub 2013 Nov 11.

ReferenceCitation: Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

ReferenceCitation: Penner IK, Stemper B, Calabrese P, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Pleimes D, Lanius V, Pohl C, Kappos L, Sandbrink R. Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis. Mult Scler. 2012 Oct;18(10):1466-71. doi: 10.1177/1352458512442438. Epub 2012 Apr 4.

ReferenceCitation: Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Metzig C, Bauer L, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009 Nov;8(11):987-97. doi: 10.1016/S1474-4422(09)70237-6. Epub 2009 Sep 10.

ReferenceCitation: Hartung HP, Freedman MS, Polman CH, Edan G, Kappos L, Miller DH, Montalban X, Barkhof F, Petkau J, White R, Sahajpal V, Knappertz V, Beckmann K, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Interferon beta-1b-neutralizing antibodies 5 years after clinically isolated syndrome. Neurology. 2011 Aug 30;77(9):835-43. doi: 10.1212/WNL.0b013e31822c90d7. Epub 2011 Aug 17. Erratum In: Neurology. 2011 Sep 27;77(13):1317.

ReferenceCitation: Freedman MS, Metzig C, Kappos L, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Yarden J, Spector L, Fire E, Dotan N, Schwenke S, Lanius V, Sandbrink R, Pohl C. Predictive nature of IgM anti-alpha-glucose serum biomarker for relapse activity and EDSS progression in CIS patients: a BENEFIT study analysis. Mult Scler. 2012 Jul;18(7):966-73. doi: 10.1177/1352458511432327. Epub 2011 Dec 19.

ReferenceCitation: Waschbisch A, Sandbrink R, Hartung HP, Kappos L, Schwab S, Pohl C, Wiendl H. Evaluation of soluble HLA-G as a biomarker for multiple sclerosis. Neurology. 2011 Aug 9;77(6):596-8. doi: 10.1212/WNL.0b013e318228c14d. Epub 2011 Jul 27. No abstract available.

ReferenceCitation: Moraal B, Pohl C, Uitdehaag BM, Polman CH, Edan G, Freedman MS, Hartung HP, Kappos L, Miller DH, Montalban X, Lanius V, Sandbrink R, Barkhof F. Magnetic resonance imaging predictors of conversion to multiple sclerosis in the BENEFIT study. Arch Neurol. 2009 Nov;66(11):1345-52. doi: 10.1001/archneurol.2009.243.

ReferenceCitation: Polman C, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Selmaj K, Uitdehaag BM, Dahms S, Bauer L, Pohl C, Sandbrink R; BENEFIT investigators. Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. J Neurol. 2008 Apr;255(4):480-7. doi: 10.1007/s00415-007-0733-2. Epub 2007 Nov 15.

ReferenceCitation: Caloyeras JP, Zhang B, Wang C, Eriksson M, Fredrikson S, Beckmann K, Knappertz V, Pohl C, Hartung HP, Shah D, Miller JD, Sandbrink R, Lanius V, Gondek K, Russell MW. Cost-effectiveness analysis of interferon beta-1b for the treatment of patients with a first clinical event suggestive of multiple sclerosis. Clin Ther. 2012 May;34(5):1132-44. doi: 10.1016/j.clinthera.2012.03.004. Epub 2012 Apr 27.

ReferenceCitation: Nielsen JM, Pohl C, Polman CH, Barkhof F, Freedman MS, Edan G, Miller DH, Bauer L, Sandbrink R, Kappos L, Uitdehaag BM. MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome. BMC Neurol. 2009 May 20;9:19. doi: 10.1186/1471-2377-9-19.

ReferenceCitation: Barkhof F, Polman CH, Radue EW, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Poppe P, de Vos M, Lasri F, Bauer L, Dahms S, Wagner K, Pohl C, Sandbrink R. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol. 2007 Sep;64(9):1292-8. doi: 10.1001/archneur.64.9.1292.

ReferenceCitation: Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Bauer L, Dahms S, Lanius V, Pohl C, Sandbrink R; BENEFIT Study Group. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007 Aug 4;370(9585):389-97. doi: 10.1016/S0140-6736(07)61194-5.

ReferenceCitation: De Jager PL, Chibnik LB, Cui J, Reischl J, Lehr S, Simon KC, Aubin C, Bauer D, Heubach JF, Sandbrink R, Tyblova M, Lelkova P; Steering committee of the BENEFIT study; Steering committee of the BEYOND study; Steering committee of the LTF study; Steering committee of the CCR1 study; Havrdova E, Pohl C, Horakova D, Ascherio A, Hafler DA, Karlson EW. Integration of genetic risk factors into a clinical algorithm for multiple sclerosis susceptibility: a weighted genetic risk score. Lancet Neurol. 2009 Dec;8(12):1111-9. doi: 10.1016/S1474-4422(09)70275-3. Epub 2009 Oct 29.

lead_sponsor: Bayer

location_country:
Finland
Germany
Poland
Canada
France
Slovenia
Czech Republic
Portugal
Hungary
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Israel


title: RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

summary: A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.

ReferenceCitation: Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
France
Germany
Italy
Poland
Hungary
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Spain
South Africa
Czech Republic

location_facility: 1160.25.02703 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03306 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06113 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03404 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06104 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03303 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04807 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03603 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04571 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03309 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06106 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04602 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04302 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03406 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03410 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03308 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03405 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03103 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04303 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06105 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03101 Boehringer Ingelheim Investigational Site

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location_facility: 1160.25.03411 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04605 Boehringer Ingelheim Investigational Site

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location_facility: 1160.25.42009 Boehringer Ingelheim Investigational Site

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location_facility: 1160.25.04304 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04912 Orthopädische Klinik Markgröningen gGmbH

location_facility: 1160.25.06111 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02702 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35802 Boehringer Ingelheim Investigational Site

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location_facility: 1160.25.04610 Boehringer Ingelheim Investigational Site

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location_facility: 1160.25.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42010 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04601 Boehringer Ingelheim Investigational Site

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title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.

acronym: FLEX

summary: The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Eberhardt WE, de Marinis F, Heeger S, Goddemeier T, O'Byrne KJ, Gatzemeier U. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer. 2012 Aug;77(2):376-82. doi: 10.1016/j.lungcan.2012.03.010. Epub 2012 Apr 11.

ReferenceCitation: Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. doi: 10.1016/S1470-2045(11)70318-7. Epub 2011 Nov 4.

ReferenceCitation: O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795-805. doi: 10.1016/S1470-2045(11)70189-9. Epub 2011 Jul 22.

ReferenceCitation: Gatzemeier U, von Pawel J, Vynnychenko I, Zatloukal P, de Marinis F, Eberhardt WE, Paz-Ares L, Schumacher KM, Goddemeier T, O'Byrne KJ, Pirker R. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol. 2011 Jan;12(1):30-7. doi: 10.1016/S1470-2045(10)70278-3. Epub 2010 Dec 17.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
France
Czech Republic
Slovakia
Hungary
Hong Kong
Switzerland
Ukraine
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Sweden


title: Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

summary: The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Lithuania
United Kingdom
Austria
Spain
Canada
France


title: A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

summary: To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

ReferenceCitation: Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. doi: 10.1186/1745-6215-7-25.

sponsor_collaborators: Pfizer Sanofi

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France


title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

acronym: BENEFIT-EXT

summary: The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

ReferenceCitation: Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.

evidence: open (via free article)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Hungary
United States
Belgium
Italy
Norway
United Kingdom
Austria
Spain
South Africa
Sweden

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: University Of California San Francisco Medical Center

location_facility: Drexel University College Of Medicine, Department Of Surgery

location_facility: Western New England Renal & Transplant Associates, Pc

location_facility: Columbia University College Of Physicians & Surgeons

location_facility: Northwestern University-Feinberg School Of Medicine

location_facility: Ucla Kidney & Kidney-Pancreas Transplant Research Office

location_facility: University Of North Carolina At Chapel Hill

location_facility: Washington University School Of Medicine

location_facility: University Of Colorado Health Sciences Center


title: A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis

summary: This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Costa Rica
Chile
Canada
France
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Belgium
Peru
Puerto Rico
Philippines
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation


title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, When Administered as 30, 50, and 75 mg Once Daily for 12 Weeks in Subjects With

summary: SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

ReferenceCitation: McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH; TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227-36. doi: 10.1056/NEJMoa073255.

location_country:
Germany
United Kingdom
United States
Puerto Rico
France


title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

summary:
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

ReferenceCitation: Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.

evidence: oa journal (via publisher name)

publisher_dissemination: Hindawi

location_country:
Finland
France
Germany
Italy
Poland
Hungary
Norway
United Kingdom
Australia
Sweden
Belgium
United States
Spain
South Africa
Turkey
Bulgaria
Russian Federation
Czech Republic


title: A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

summary: The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

ReferenceCitation: Pappas PG, Rotstein CM, Betts RF, Nucci M, Talwar D, De Waele JJ, Vazquez JA, Dupont BF, Horn DL, Ostrosky-Zeichner L, Reboli AC, Suh B, Digumarti R, Wu C, Kovanda LL, Arnold LJ, Buell DN. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007 Oct 1;45(7):883-93. doi: 10.1086/520980. Epub 2007 Aug 29. Erratum In: Clin Infect Dis. 2008 Jul 15;47(2):302.

ReferenceCitation: Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. doi: 10.1093/jac/dkq446. Epub 2010 Dec 8.

lead_sponsor: Astellas Pharma Inc

location_country:
France
Germany
Poland
India
United Kingdom
Brazil
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Croatia
Canada
Czech Republic


title: A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

summary: The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.

ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Sonneveld P, Hajek R, Nagler A, Spencer A, Blade J, Robak T, Zhuang SH, Harousseau JL, Orlowski RZ; DOXIL-MMY-3001 Study Investigators. Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. Cancer. 2008 Apr 1;112(7):1529-37. doi: 10.1002/cncr.23326.

ReferenceCitation: Orlowski RZ, Nagler A, Sonneveld P, Blade J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. doi: 10.1200/JCO.2006.10.5460. Epub 2007 Aug 6.

lead_sponsor: Janssen Research & Development, LLC

location_country:
France
Poland
Portugal
Israel
Argentina
Singapore
Australia
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
South Africa
Canada
Russian Federation
Czech Republic


title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

ReferenceCitation: Hollander P, Cooper J, Bregnhoj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

location_country:
Finland
France
Norway
United States
Sweden


title: A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

summary: This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

ReferenceCitation: Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.

location_country:
Germany
Italy
Portugal
United Kingdom
Brazil
Sweden
Switzerland
Belgium
United States
Spain
Greece
Turkey
Canada
France


title: See Detailed Description

summary: This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

ReferenceCitation: Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1. Erratum In: Lancet. 2006 Oct 7;368(9543):1238.

location_country:
Germany
Italy
Poland
Portugal
Romania
Switzerland
Austria
Belgium
United States
Latvia
Spain
Luxembourg
Canada
France


title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

summary: The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

ReferenceCitation: Laterre PF, Opal SM, Abraham E, LaRosa SP, Creasey AA, Xie F, Poole L, Wunderink RG. A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia. Crit Care. 2009;13(2):R36. doi: 10.1186/cc7747. Epub 2009 Mar 15.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
New Zealand
United Kingdom
Argentina
Singapore
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Malaysia
South Africa
Chile
Peru
Canada
France


title: A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

summary: This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

ReferenceCitation: Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.

location_country:
Germany
Italy
New Zealand
Australia
United States
Spain
Canada
Puerto Rico
France


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

summary: This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

ReferenceCitation: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

ReferenceCitation: Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15. Erratum In: Oncologist. 2010;15(3):327. Schwarzberg, Lee S [corrected to Schwartzberg, Lee S].

ReferenceCitation: Sherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26.

ReferenceCitation: Finn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6.

ReferenceCitation: Prat A, Cheang MC, Galvan P, Nuciforo P, Pare L, Adamo B, Munoz M, Viladot M, Press MF, Gagnon R, Ellis C, Johnston S. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. 2016 Oct 1;2(10):1287-1294. doi: 10.1001/jamaoncol.2016.0922.

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.

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

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Pakistan
Czechia
Canada
France
Colombia
Hungary
Denmark
United States
Tunisia
Peru
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation


title: Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

summary:
The purposes of this study are to determine:

Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

ReferenceCitation: Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.

ReferenceCitation: Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-843. doi: 10.1016/S0140-6736(07)60411-5.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
Australia
Switzerland
Mexico
United States
Chile
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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

summary:
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.

The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

lead_sponsor: Forest Laboratories

location_country:
Germany
Italy
Poland
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2

location_facility: Catharina Ziekenhuis Afd. Cardiologie Postbus 1350

location_facility: University of Mass. Medical Ctr. Division of Cardiovascular Medicine

location_facility: Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3

location_facility: Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5

location_facility: Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58

location_facility: Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10

location_facility: Cardiac Arrythmia Trials/Royal Jubilee Hosp.

location_facility: Memorial Health Systems/Cardiology Research Associates

location_facility: CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu

location_facility: Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17

location_facility: Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1

location_facility: Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11

location_facility: Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52

location_facility: Baystate Medical Center-Cardiology Research

location_facility: Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42

location_facility: Klinikum der Stadt Ludwigshafen Bremserstr. 79

location_facility: Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8

location_facility: Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18

location_facility: Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7

location_facility: Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25

location_facility: CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours

location_facility: Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1

location_facility: CHRU de Nancy-29 av. de Lattre de Tassigny

location_facility: Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40

location_facility: Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29

location_facility: Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25

location_facility: Hamilton General Hospital/McMaster Clinic

location_facility: Hopital cardiologique du Haut Leveque-av. de Magellan

location_facility: Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20

location_facility: 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47

location_facility: Louisville Cardiology Medical Group, PSC

location_facility: Deutsches Herzzentrum Minchen Lazarettstr. 36

location_facility: Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20

location_facility: Clinica Puerta de Hierro, San Martin de Porres, 4

location_facility: Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4

location_facility: CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc

location_facility: Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50

location_facility: Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50

location_facility: Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170

location_facility: Oddzial kardiologii-Instut kardiologii, Ul Powstancow

location_facility: SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1

location_facility: Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600

location_facility: Heart Place/Baylor University of Medicine

location_facility: Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9

location_facility: The Cardiovascular Grp./Attn: Mandy Murphy

location_facility: ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1

location_facility: Klinikum Grobhadern Universitat Munchen Marchioninistr. 15

location_facility: Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20

location_facility: St Michaels Hospital 30 Bond Street 7-050 Queen

location_facility: CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod

location_facility: Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11

location_facility: University of Rochester Strong mem. Hospital

location_facility: Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n

location_facility: Mid-America Cardiology c/o KU medical Ctr

location_facility: Centre hospitalier L. Pradel-28 av. du doyen Lepine

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2

location_facility: Medizinische Universitatsklinik Leipzigerstr. 44


type: Registry Identifier

title: Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

summary: The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).

study_start_date_type: Anticipated

status: Recruiting

study_completion_date_type: Anticipated

sponsor_collaborators:
Bristol-Myers Squibb
Zai Lab (Shanghai) Co., Ltd.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Chile
Canada
France
Hungary
Switzerland
United States
India
Romania
China
Italy
Austria
Korea, Republic of
Spain
Greece

location_facility:
Local Institution - 0175
Local Institution - 0075
Local Institution - 0141
Local Institution - 0102
Local Institution - 0207
Local Institution - 0144
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0208
Local Institution - 0170
Local Institution - 0044
Local Institution - 0164
Local Institution - 0105
Local Institution - 0096
Local Institution - 0058
Local Institution - 0124
Local Institution - 0190
Local Institution - 0034
Local Institution - 0063
Local Institution - 0148
Local Institution - 0202
Local Institution - 0106
Local Institution - 0076
Local Institution - 0143
Local Institution - 0166
Local Institution - 0078
Local Institution - 0201
Local Institution - 0074
Local Institution - 0204
Local Institution - 0097
Local Institution - 0087
Local Institution - 0031
Local Institution - 0138
Local Institution - 0180
Local Institution - 0134
Local Institution - 0195
Local Institution - 0193
Local Institution - 0132
Local Institution - 0149
Local Institution - 0090
Local Institution - 0070
Local Institution - 0173
Local Institution - 0177
Local Institution - 0037
Local Institution - 0156
Local Institution - 0033
Local Institution - 0169
Local Institution - 0139
Local Institution - 0085
Local Institution - 0109
Local Institution - 0174
Local Institution - 0167
Local Institution - 0155
Local Institution - 0168
Local Institution - 0079
Local Institution - 0131
Local Institution - 0066
Local Institution - 0060
Local Institution - 0159
Local Institution - 0154
Local Institution - 0196
Local Institution - 0165
Local Institution - 0152
Sendai Kousei Hospital
Local Institution - 0082
Local Institution - 0150
Local Institution - 0171
Local Institution - 0083
Local Institution - 0140
Local Institution - 0117
Local Institution - 0067
Local Institution - 0059
Local Institution - 0081
Local Institution - 0178
Local Institution - 0186
Local Institution - 0194
Local Institution - 0181
Local Institution - 0091
Local Institution - 0064
Local Institution - 0206
Local Institution - 0151
Local Institution - 0118
Local Institution - 0108
Local Institution - 0142
Local Institution - 0114
Local Institution - 0065
Local Institution - 0049
Local Institution - 0187
Local Institution - 0048
Local Institution - 0163
Local Institution - 0122
Local Institution - 0029
Local Institution - 0057
Local Institution - 0030
Local Institution - 0084
Local Institution - 0205
Local Institution - 0189
Local Institution - 0198
Local Institution - 0041
Local Institution - 0092
Osaka City General Hospital
Local Institution - 0055
Local Institution - 0002
Local Institution - 0032
Local Institution - 0135
Local Institution - 0203
Local Institution - 0184
Local Institution - 0147
Local Institution - 0073
Local Institution - 0179
Local Institution - 0192
Local Institution - 0199
Local Institution - 0062
Local Institution - 0153
Local Institution - 0094
Local Institution - 0086
Local Institution - 0185
Local Institution - 0056
Local Institution - 0045
Local Institution - 0210
Local Institution - 0137
Local Institution - 0127
Local Institution - 0123
Local Institution - 0093
Local Institution - 0098
Local Institution - 0183
Local Institution - 0088

status_simplified: Ongoing


title: A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria

summary: This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

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 requests 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
Argentina
Australia
Japan
Thailand
Vietnam
Turkey
Canada
France
Slovakia
Denmark
United States
China
Philippines
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Bulgaria
Israel


title: A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

summary: The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.

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

sponsor_collaborators:
Incyte Corporation
Mirati Therapeutics Inc.

location_country:
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Mary Crowley Cancer Research Centers McCrc Headquarters

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: London Regional Cancer Program London Health Sciences Centre

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

location_facility: Novant Health Presbyterian Medical Center

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Jewish General Hospital / McGill University

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Nebraska Medical Center-Peggy D Cowdery Patient Care Center

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

location_facility: Hospital General Universitario Vall D Hebron


title: A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

summary: The primary objective of the study is to rule out an increase of >3mmHg in 24-hour average Systolic Blood Pressure at steady state (Week 4) compared to baseline. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

location_country:
Germany
Slovakia
Argentina
Singapore
United States
Korea, Republic of
Spain
Turkey
Canada
France


title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

summary: The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

location_country:
Germany
Italy
Poland
Denmark
Australia
Switzerland
Austria
United States
Korea, Republic of
Spain
Bulgaria
Canada
France

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Activmed Practices Research, Llc Beverly

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Clinical Science Institute Clinical Research Specialists Inc

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Diamond Clinic Specjalistyczne Poradnie Lekarskie

location_facility: University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building

location_facility: Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli

location_facility: Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

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

location_facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

location_facility: Marietta Dermatology the Skin Cancer Center Marietta

location_facility: Northwest Arkansas Clinical Trials Center

location_facility: Klinikum Bielefeld Rosenhohe Dermatologie

location_facility: University of Pennsylvania-Perelman School of Medicine

location_facility: Company For Medical Study & Service Selters Gmbh

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen in Individuals With Prodromal and Early Manifest Huntington's Disease

summary: This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Italy
Poland
Portugal
New Zealand
United Kingdom
Argentina
Denmark
Australia
Switzerland
Austria
United States
Spain
Canada
France

location_facility: St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: John Hopkins University School of Medicine

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica

location_facility: Hopital Henri Mondor; Service de Neurologie

location_facility: Montreal Neurological Inst; Clinical Research Unit

location_facility: Uniklinik RWTH Aachen; Klinik für Neurologie

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: CenExel Rocky Mountain Clinical Research, LLC

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Chapel Allerton Hospital; Clinical Genetics

location_facility: Hopital Roger Salengro Service de Neurologie

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Southampton University Hospitals NHS Trust

location_facility: Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

location_facility: Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

location_facility: Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: University of Iowa Hospitals and Clinics

location_facility: Perron Institute for Neurological and Translational Science

location_facility: German Center for Neurodegenerative Diseases (DZNE)

location_facility: CHU Angers, Batiement Larrey 2, Neurologie

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: WESTMEAD HOSPITAL; Deparment of Neurology

location_facility: University of California Davis Medical System

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche

location_facility: Georgetown University; Research Division, Psychiatry

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Hospital Universitario de Badajoz; Servicio de Neurología

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


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

summary: The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.

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

location_country:
Germany
Poland
Japan
Netherlands
Austria
Belgium
United States
Spain
Greece
Czechia
Canada
France

location_facility:
Investigative Site NL303
Investigative Site US315
Investigative Site US324
Investigative Site JP301
Investigative Site US306
Investigative Site GR300
Investigative Site DE304
Investigative Site US307
Investigative Site FR306
Investigative Site US319
Investigative Site BE301
Investigative Site JP308
Investigative Site ES302
Investigative Site US318
Investigative Site JP303
Investigative Site NL302
Investigative Site US316
Investigative Site JP306
Investigative Site US323
Investigative Site GR303
Investigative Site JP300
Investigative Site FR305
Investigative Site BE300
Investigative Site CZ301
Investigative Site CA304
Investigative Site PL304
Investigative Site DE303
Investigative Site US302
Investigative Site FR301
Investigative Site PL301
Investigative Site CA301
Investigative Site JP302
Investigative Site US310
Investigative Site ES303
Investigative Site JP307
Investigative Site US308
Investigative Site GR302
Investigative Site CA303
Investigative Site FR300
Investigative Site ES300
Investigative Site AT304
Investigative Site DE306
Investigative Site PL302
Investigative Site US320
Investigative Site DE307
Investigative Site DE305
Investigative Site BE306
Investigative Site BE304
Investigative Site US312
Investigative Site AT300
Investigative Site AT302
Investigative Site US313
Investigative Site US314
Investigative Site GR301
Investigative Site FR302
Investigative Site US317
Investigative Site CA306
Investigative Site AT306
Investigative Site DE300
Investigative Site AT305
Investigative Site 00A
Investigative Site CA302
Investigative Site US311
Investigative Site DE302
Investigative Site FR304
Investigative Site JP304
Investigative Site JP305
Investigative Site DE301
Investigative Site BE303
Investigative Site BE302
Investigative Site AT301
Investigative Site US300
Investigative Site FR307
Investigative Site ES301
Investigative Site CZ300
Investigative Site US303
Investigative Site FR303
Investigative Site JP309
Investigative Site US304
Investigative Site US321
Investigative Site CA307
Investigative Site PL303
Investigative Site US301
Investigative Site ES305
Investigative Site ES304
Investigative Site NL301
Investigative Site BE305