title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)

summary: The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

ReferenceCitation: Chanan-Khan AA, Zaritskey A, Egyed M, Vokurka S, Semochkin S, Schuh A, Kassis J, Simpson D, Zhang J, Purse B, Foà R. Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2017 Nov;4(11):e534-e543. doi: 10.1016/S2352-3026(17)30168-0. Epub 2017 Sep 25.

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Mexico
Sweden
Canada
Hungary
Germany
Denmark
Ireland
New Zealand
France
Colombia
Netherlands

location_facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin

location_facility: Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Azienda Ospedaliero Universitaria OORR Foggia

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Innere Medizin Klinikum Frankfurt Oder GmBH

location_facility: Clinical Trials Unit The St George Hospital

location_facility: Specjalistyczny Szpital miejski im. Kopernika

location_facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

location_facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

location_facility: SUNY Upstate Medical University Medicine Oncology

location_facility: State Budgetary Institution of the City of Moscow

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE

location_facility: St. Petersburg Pavlov State Medical Univ

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: General Faculty Hosital1.Internal Clinic

location_facility: St. Bartholomew's and The Royal London Hospital

location_facility: Drexel University, College of Medicine, Clinical Research Group

location_facility: Florida Hospital Cancer Institute Waterman

location_facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: State Healthcare Institution Sverdlovsk regional clinical hospital 1

location_facility: Singleton Hospital, Southwest Wales Cancer Inst

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Vittorio Emanuele-Ferrarotto

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: GUZ Volgograd Regional Clinical Oncology

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

location_facility: Hematology Oncology Assoc. of IL Orchard Research LLC

location_facility: CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire

location_facility: Charite, Campus Benjamin Franklin, Medizinische Klinik III

location_facility: Biomedical Research Alliance of New York, LLC

location_facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

location_facility: Royal North Shore HospitalDepartment of HematologyLevel 4

location_facility: Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies

location_facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Istituto dei Tumori Giovanni Paolo II di Bari

location_facility: Praxis fuer Haematologie und Onkologie Koblenz

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Medical University of Vienna Internalmedicine 1, Hematology

location_facility: Haematology and Oncology Clinics of Australasia

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: GUS Leningrad Regional Clinical Hospital

location_facility: FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Wilgers Oncology CentreWilgrers Hospital

location_facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

location_facility: Northwestern University, Division of Hematology Oncology, Dept. of Medicine

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

location_facility: Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Abington Hematology Oncology Associates Inc

location_facility: Hopital Petie- SalpetriereDepartment d'Hematologie

location_facility: Azienda Ospedaliero Universitaria di Modena


title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Spain
Italy
Canada
Switzerland
Hungary
United States
France
Belgium
Germany

location_facility: University of California Irvine Medical Center

location_facility: Cancer Care Specialists of Central Illinois

location_facility: Mamie McFadden Ward Cancer Ctr, Texas Oncology

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Texas Oncology Cancer Care Center & Research Center

location_facility: Ventura County Hematology/Oncology Specialists

location_facility: Hematology/Oncology Associates of Treasure Coast

location_facility: California Pacific Medical Research Institute

location_facility: Harry & Jeannette Weinberg Cancer Institute

location_facility: Palo Alto Medical Foundation - Camino Div.

location_facility: Central Hematology Oncology Medical Group

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


status: Completed

title: A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Ravaud A, Barrios CH, Alekseev B, Tay MH, Agarwala SS, Yalcin S, Lin CC, Roman L, Shkolnik M, Anak O, Gogov S, Pelov D, Louveau AL, Melichar B. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon α-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Hong Kong
Russian Federation
Turkey
Singapore
Egypt
Brazil
Switzerland
Hungary
Germany
Taiwan
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

location_facility: Las Colinas Hematology Oncology Grapevine

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

location_facility: Nevada Cancer Institute Dept. of Nevada Cancer (3)

location_facility: University of California at Los Angeles Dept. of Hem/Oncology

location_facility: Seattle Cancer Care Alliance Dept. of SCCA

summary: To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

status_simplified: Completed


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Australia
Argentina
Israel
Turkey
Singapore
Sweden
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Peninsula Regional Oncology and Hematology

location_facility: Providence Everett Medical Center/Providence regional Cancer Partnership

location_facility: University of South Alabama/Mitchell Cancer Institute

location_facility: Texas Oncology Cancer Center of the High Plains

location_facility: Hematology Oncology Associates of Rockland

location_facility: Pacific Oncology and Hematology Association

location_facility: Advocate Illinois Masonic Medical Center

location_facility: Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc

location_facility: University of Louisville - James Graham Brown Cancer Center

location_facility: Rochester General Hospital - Lipson Cancer Center

location_facility: Medical College of Wisconsin/Division of Neoplastic & Related Disorders

location_facility: University of Oklahoma Health Science Center

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Kansas City Veterans Affair Medical Center

location_facility: Medical Oncology & Hematology Associates of Northern Virginia

location_facility: Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute

location_facility: Siouxland Hematology-Oncology Assoc., LLC

location_facility: The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health

location_facility: Allegheny General Hospital/Allegheny Cancer Center

location_facility: Loyola Cancer Care & Research Ctr. at Central Dupage Hospital

location_facility: Center for Cancer Care and Research (US Oncology)

location_facility: St. Luke's Hospital - St Luke's Cancer Center

location_facility: Osteopathic Medical Oncology and Hematology PC

location_facility: Illinois Oncology/Warren Billhartz Cancer Ctr.

location_facility: Palm Beach Institute of Hematology & Oncology

location_facility: Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center

location_facility: University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center

location_facility: Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program

location_facility: Alamance Regional Medical Center-Cancer Ctr.

location_facility: University of California Irvine Comprhensive Center

location_facility: Cleo Craig Memorial Cancer Ctr. & Research Clinic


title: A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy

summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

ReferenceCitation: Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczésna A, Juhász E, Esteban E, Molinier O, Brugger W, Melezínek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
Venezuela
Romania
Belgium
South Africa
Poland
Slovenia
Austria
Australia
Russian Federation
Malaysia
Slovakia
Canada
Hungary
China
Germany
Denmark
Greece
New Zealand
Czech Republic
Korea, Republic of
France
Chile
Netherlands


acronym: ALTITUDE

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

ReferenceCitation: Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.

ReferenceCitation: Heerspink HJ, Persson F, Brenner BM, Chaturvedi N, Brunel P, McMurray JJ, Desai AS, Solomon SD, Pfeffer MA, Parving HH, de Zeeuw D. Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi: 10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.

ReferenceCitation: Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.

ReferenceCitation: Lambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31. doi: 10.1097/HJH.0b013e3283310f92. Review.

location_country:
Spain
Italy
United Kingdom
Lithuania
Venezuela
United States
Peru
Belgium
Japan
South Africa
Portugal
Austria
Argentina
Puerto Rico
India
Turkey
Norway
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Guatemala
Hungary
China
Germany
Denmark
Taiwan
Greece
Finland
Czech Republic
Thailand
Korea, Republic of
France
Colombia
Netherlands

summary:
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.


title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

summary: The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

ReferenceCitation: Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

ReferenceCitation: Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gómez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

ReferenceCitation: Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
Ukraine
United States
Romania
Belgium
Poland
Russian Federation
Australia
Puerto Rico
India
Israel
Slovakia
Egypt
Brazil
Canada
Germany
Taiwan
Greece
Czech Republic
Korea, Republic of
France
Pakistan


title: A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Midazolam for Continuous Sedation of Ventilated Patients in Intensive Care Unit

acronym: MIDEX

summary:
Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Midazolam is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation)

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study, dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam.

in this study we hope to show that: dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable, and that they are able to co-operate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.

ReferenceCitation: Turunen H, Jakob SM, Ruokonen E, Kaukonen KM, Sarapohja T, Apajasalo M, Takala J. Dexmedetomidine versus standard care sedation with propofol or midazolam in intensive care: an economic evaluation. Crit Care. 2015 Feb 19;19:67. doi: 10.1186/s13054-015-0787-y.

ReferenceCitation: Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
United Kingdom
Estonia
Netherlands
Finland
Switzerland
France
Belgium
Norway
Germany

location_facility: Saint Elisabeth Ziekenhuis, Dept. Intensieve Zorgen, Hilvarenbeekseweg 60

location_facility: North Estonian Regional Hospital, Centre of Intensive Care, J. Sutiste Tee 18

location_facility: Amphia Ziekenhuis, Dept. Intensieve Zorgen, Molengracht 21

location_facility: Aker Universtetssykehus HF, Anestesiavdelingen, Trondheimsveien 235

location_facility: UZ Brussel, Intensive Care Dept. Laarbeeklaan 101

location_facility: Universitatsklinikum Greifswald, Klinik u. Poliklinik f. Anasthesiologie u. Intensivmedizin, Friedrich-Loeffler-Str. 23b

location_facility: Gelre Hospitals - Locatie Lucas, A.Schweitzerlaan 32

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul, Service de Reanimation Medicale, 27 Rue du Faubourg Saint Jacques

location_facility: Tartu University Hospistal, Clinic of Anesthesiology and Intensive Care, L. Puusepa 8

location_facility: Centre Hospitalier Universitaire d'Orleans, Reanimation Medicale, 1, rue Prote Madeleine, BP 2439

location_facility: Isala Klinieken, Locatie Weezenlanden, Groot Wezenland 20

location_facility: Universitatsspital Zurich, Klinik fur Innere Medizin, Intensivstation, Ramistrasse 100

location_facility: Derriford Hospital, Dept. of Intensive Care Level 4, Derriford Road

location_facility: Centre Hospitalier Universitaire de Grenoble, Service de Reanimation Medicale, Boulevard de la Chantourne, BP 217

location_facility: Hopital Foch, Service Renimation, 40 Rue Worth, Suresnes Hauts de Seine

location_facility: East Tallinn Central Hospital, Ravi Stret 18

location_facility: Oulu University Hospital, Kajaanintie 50

location_facility: Centre Hospitalier Universitaire de Poitiers, Reanimation Medicale, 2, Rue de la Miletrie

location_facility: Rikshospitalet, Universitetsklinikk, Sognsvannsveien 20

location_facility: Hopital Bichat-Claude, Dept. D'Anasehesie et Reanimation Chirurgicale, 46, rue Henri-Huchard

location_facility: Universitatsklinikum Tubingen, Klinik fur Anasthesiologie und Intensivmedizin, Hoppe-Seyler-Strasse 3

location_facility: Kantonsspital Winterthur, Brauerstrasse 15,

location_facility: Universitaer Ziekenhuis Gent, Intensieve Zorgen, De Pintelaan 185

location_facility: University Hospital Birmingham, Department of Anaesthesia, Queen Elizabeth Hospital,

location_facility: Centre Hospitalier Victor Dupouy Hopital Dupuytren, Service Reanimation Polyvalente, 69, Rue du Lt Colonel Prud'hon

location_facility: Haukeland University Hospital, Intensive Care Unit, Jonas Liesvei 65

location_facility: Viecuri MC voor Noord-Limburg, Locatie Venlo, Dept. Intensieve Zorgen, Tegelseweg 210

location_facility: North Estonian Regional Hospital, Dept. of Postoperative Intensive Care, J. Sutiste Tee 18

location_facility: Ulleval University Hospital, Medical and Surgical ICU, Kirkeveien 166

location_facility: Hopital Albert Calmette, Boulevard Du Pr. Jules Leclercq

location_facility: Centre Hospitalier La Roche sur Yon CHD les Oudaireis, Service Reanimation CHD la Roche sur Yon, Les Oudairies

location_facility: Albert Schweitzer Hospital, Locatie Dordwikj, Albert Schweitzerplaats 25

location_facility: CHU de Liege (Sart Tilman), Domaine de Sart-Tilman

location_facility: Centre Hospitalier Universitaire d'Angers, Reanimation medicale est de Mededicne Hyperbare, 4 Rue Larrey

location_facility: Centre Hospitalier Regional et Universitaire - Hopital Bretonneau Service Reanimation Medicale Polyvalente, 2, Boulevard Tonnelle, Tours cedex 9

location_facility: Birmingham Heartlands Hospital, Bordesely Green East

location_facility: Universitatsklinikum Bonn, Klinik u. Poliklinik f. Anasthesiologie u. Operative Intensivmedizin, Sigmund-Freud-Strasse 25

location_facility: Centre Hospitalier Universitaire Limoges Hopital Dupuytren, Service de Reanimation Polyvalente, 2, Avenue Martin Luther King


title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

acronym: ADOPT

summary: The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

primary_purpose: Prevention

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x. Review.

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Philippines
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Jacksonville Center For Clinical Research

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Johns Hopkins University School Of Medicine

location_facility: The Milton S Hershey Medical Center Of Penn. State Univ.

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: Michael E. De Bakey Veteran Affairs Medical Center

location_facility: University Of Alabama At Birmingham Hospital

location_facility: Scripps Clinic/Scripps Health And Green Hospital

location_facility: Louisiana State University Health Sciences Center-Shreveport

location_facility: Univ. Of Southern Calif. /Norris Comprehensive Cancer Center


title: Safety and Antiviral Activity of TPV in Hepatitis C or Hepatitis B HIV Coinfected Patients - TDM Randomised Pilot Evaluation

summary: The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

lead_sponsor: Boehringer Ingelheim

location_country:
Brazil
Spain
Italy
Argentina
United States
France
Germany

location_facility: 1182.99.3310G Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310F Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3304C Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310E Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55003 Centro de Referência e Treinamento - DST/AIDS

location_facility: 1182.99.3911 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3301A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.4909 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.12 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3306K Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310D Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3306G Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55004 Unidade de Referência em doenças Infecciosas Preveníveis

location_facility: 1182.99.3310C Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3304A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3310H Boehringer Ingelheim Investigational Site

location_facility: 1182.99.31 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.1 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.3302A Boehringer Ingelheim Investigational Site

location_facility: 1182.99.55001 Universidade Federal de Sao Paulo

location_facility: 1182.99.3906 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.32 Boehringer Ingelheim Investigational Site

location_facility: 1182.99.4 Boehringer Ingelheim Investigational Site


title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

ReferenceCitation: Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12:161. doi: 10.1186/1465-9921-12-161.

ReferenceCitation: Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.

ReferenceCitation: Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

ReferenceCitation: Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

ReferenceCitation: Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.

lead_sponsor: Novartis

location_country:
Spain
Italy
United Kingdom
Lithuania
Peru
Romania
Russian Federation
Argentina
Israel
Turkey
Slovakia
Egypt
Switzerland
Hungary
Germany
Denmark
Latvia
Estonia
Ecuador
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Novartis
Novartis Investigative Site
Novartis Investigator Site


title: Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study

acronym: SOLAR

summary: This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

ReferenceType: background

ReferenceCitation: Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Czech Republic
Hungary
France
Turkey
Belgium
Netherlands

intervention_type: Behavioral


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

summary: This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

ReferenceCitation: Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31.

location_country:
Spain
Italy
Austria
United Kingdom
Finland
Sweden
United States
France
Japan
Germany

location_facility: 248.595.0121 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34005 Hospital Mutua de Terrassa

location_facility: 248.595.0123 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0134 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0131 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0129 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0106 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0141 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39005 Ospedale della Misericordia

location_facility: 248.595.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.595.34002 Nuevo Hospital de Sant Pau

location_facility: 248.595.0107 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44010 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0108 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44003 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49006 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0111 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46007 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0105 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0118 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0113 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49014 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0120 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0133 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39006 Policlinico Universitario Molinette

location_facility: 248.595.46006 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.595.81002 Kagawa Prefectural Central Hospital

location_facility: 248.595.49011 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0140 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39011 Ospedale S. Raffaele - IRCCS

location_facility: 248.595.43002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306A Centre Hospitalier du Pays d'Aix

location_facility: 248.595.0115 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0136 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0116 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento

location_facility: 248.595.43003 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39007 Ospedale Evangelico Valdese

location_facility: 248.595.0124 Boehringer Ingelheim Investigational Site

location_facility: 248.595.81001 Juntendo University Hospital

location_facility: 248.595.0127 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0109 Boehringer Ingelheim Investigational Site

location_facility: 248.595.35804 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0122 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0139 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39014 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0119 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0101 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49010 Boehringer Ingelheim Investigational Site

location_facility: 248.595.43005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0137 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0112 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa

location_facility: 248.595.0114 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena

location_facility: 248.595.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44011 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0103 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44005 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44004 Boehringer Ingelheim Investigational Site

location_facility: 248.595.44008 Boehringer Ingelheim Investigational Site

location_facility: 248.595.39004 Università degli Studi di Bari

location_facility: 248.595.44001 Boehringer Ingelheim Investigational Site

location_facility: 248.595.46002 Boehringer Ingelheim Investigational Site

location_facility: 248.595.49009 Boehringer Ingelheim Investigational Site

location_facility: 248.595.3306C Centre Hospitalier du Pays d'Aix

location_facility: 248.595.34001 Hospital Clinic i Provincial of Barcelona

location_facility: 248.595.3306B Centre Hospitalier du Pays d'Aix

location_facility: 248.595.0102 Boehringer Ingelheim Investigational Site

location_facility: 248.595.0104 Boehringer Ingelheim Investigational Site


title: Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

summary: The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Goh KL, Choi KD, Choi MG, Hsieh TY, Jung HY, Lien HC, Menon J, Mesenas S, Park H, Sheu BS, Wu JC. Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients. BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.

ReferenceCitation: Heading RC, Mönnikes H, Tholen A, Schmitt H. Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole. BMC Gastroenterol. 2011 May 11;11:52. doi: 10.1186/1471-230X-11-52.

lead_sponsor: Takeda

location_country:
Spain
Italy
United Kingdom
Belgium
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
India
Mexico
Malaysia
Singapore
Brazil
Canada
Switzerland
Germany
Taiwan
Korea, Republic of
France


title: A Randomized, Controlled Trial to Evaluate the Effects of Nadroparin on Survival and Disease Progression in Patients With Advanced Malignancies of the Lung, Pancreas, or Prostate

summary: This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).

ReferenceCitation: van Doormaal FF, Di Nisio M, Otten HM, Richel DJ, Prins M, Buller HR. Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol. 2011 May 20;29(15):2071-6. doi: 10.1200/JCO.2010.31.9293. Epub 2011 Apr 18.

ipd_sharing: Yes

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:
Poland
Slovenia
Italy
Russian Federation
Netherlands
Canada
Czech Republic
Hungary
France
Belgium
Germany


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms

summary:
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.

However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.

The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.

Also data on the safety of the product in the disease will be collected.

ReferenceCitation: Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
Finland
Ukraine
Sweden
France
South Africa
Romania
Norway
Germany

location_facility: 248.596.39008 Clinica Neurologica I Policlinico di Catania

location_facility: 248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología

location_facility: 248.596.40006 Country Clinical Emergency Hospital

location_facility: 248.596.70001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27007 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología

location_facility: 248.596.39009 Istituti Clinici di Perfezionamento

location_facility: 248.596.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27006 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología

location_facility: 248.596.34004 Hospital General de Catalunya. Departamento de Neurología

location_facility: 248.596.38004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39006 Neurologia Ospedale Evangelico Valdese

location_facility: 248.596.38003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49013 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"

location_facility: 248.596.40003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3301A Hôpital Guillaume et René Laennec

location_facility: 248.596.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39004 Neurologia Ospedale della Misericordia

location_facility: 248.596.70003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3302A Centre Hospitalier du Pays d'Aix

location_facility: 248.596.40004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27008 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología

location_facility: 248.596.46002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3302B Centre Hospitalier du Pays d'Aix

location_facility: 248.596.43002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49014 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39003 Università degli studi di Napoli "Federico II"

location_facility: 248.596.39007 Clinica Neurologica Policlinico Tor Vergata

location_facility: 248.596.31004 Amphia ziekenhuis, Locatie Molengracht

location_facility: 248.596.70004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39005 Clinica Neurologica Policlinico G. Martino

location_facility: 248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA

location_facility: 248.596.47004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.47003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34003 Hospital de Alcorcón. Departamento de Neurología

location_facility: 248.596.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38006 Boehringer Ingelheim Investigational Site

location_facility: 248.596.47002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38002 Boehringer Ingelheim Investigational Site

intervention_type: Other


type: Other Identifier

title: Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers

summary: The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

lead_sponsor: Bayer

location_country: Austria Finland Spain France


title: A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

acronym: CHOICE

summary: This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.

ReferenceType: result

ReferenceCitation: Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390.

ReferenceCitation: Lundström E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56.

ReferenceCitation: Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31.

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
United Kingdom
Austria
Finland
Switzerland
Sweden
France
Belgium
Norway
Germany


title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

summary: This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

ReferenceCitation: Vilsbøll T, Brock B, Perrild H, Levin K, Lervang HH, Kølendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.

ReferenceCitation: Courrèges JP, Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Bugáñová I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x.

ReferenceCitation: Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courrèges JP, Verhoeven R, Bugánová I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. Epub 2007 Mar 19.

ReferenceCitation: Horowitz M, Vilsbøll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22.

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. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

location_country: Denmark France Slovakia Netherlands


title: A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

summary: The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

location_country:
Denmark
Italy
Netherlands
Canada
France
South Africa
Belgium
Germany

location_facility: Med. Einrichtung der Universitat zu Koln

location_facility: A.O. S. Martino e Cliniche Universitarie di Genova

location_facility: Department of Medicine, Health Sciences Centre

location_facility: A. O. Universitaria di Ferrara - Arcispedale S. Anna

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus


title: Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy

summary:
Objectives

Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy
Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.
Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.

ReferenceCitation: Bachy E, Seymour JF, Feugier P, Offner F, López-Guillermo A, Belada D, Xerri L, Catalano JV, Brice P, Lemonnier F, Martin A, Casasnovas O, Pedersen LM, Dorvaux V, Simpson D, Leppa S, Gabarre J, da Silva MG, Glaisner S, Ysebaert L, Vekhoff A, Intragumtornchai T, Le Gouill S, Lister A, Estell JA, Milone G, Sonet A, Farhi J, Zeuner H, Tilly H, Salles G. Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study. J Clin Oncol. 2019 Nov 1;37(31):2815-2824. doi: 10.1200/JCO.19.01073. Epub 2019 Jul 24.

ReferenceCitation: Zhou X, Wang J, Zhang J, Copley-Merriman C, Torigoe Y, Reyes C, Seymour JF, Offner FC, Trneny M, Salles GA. Symptoms and toxicity of rituximab maintenance relative to observation following immunochemotherapy in patients with follicular lymphoma. Hematology. 2015 Apr;20(3):129-36. doi: 10.1179/1607845414Y.0000000179. Epub 2014 Jul 16.

ReferenceCitation: Ghesquières H, Cartron G, Seymour JF, Delfau-Larue MH, Offner F, Soubeyran P, Perrot A, Brice P, Bouabdallah R, Sonet A, Dupuis J, Casasnovas O, Catalano JV, Delmer A, Jardin F, Verney A, Dartigues P, Salles G. Clinical outcome of patients with follicular lymphoma receiving chemoimmunotherapy in the PRIMA study is not affected by FCGR3A and FCGR2A polymorphisms. Blood. 2012 Sep 27;120(13):2650-7. Epub 2012 Aug 10.

ReferenceCitation: Salles G, Seymour JF, Offner F, López-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Fermé C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20. Erratum in: Lancet. 2011 Apr 2;377(9772):1154.

ipd_sharing: No

lead_sponsor: Lymphoma Study Association

location_country:
Denmark
Brazil
Belgium
Spain
Australia
New Zealand
Argentina
Thailand
France
Peru
Colombia
Netherlands

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Instituo Nacional de Enfermedades Neoplasicas

location_facility: Australia New Zealand Leukemia Lymphoma Group

location_facility: Groupe d'Etude des Lymphomes de l'adulte


title: Duloxetine 60 to 120 mg Once Daily Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

summary: This is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.

ReferenceCitation: Perlis RH, Fijal B, Dharia S, Houston JP. Pharmacogenetic investigation of response to duloxetine treatment in generalized anxiety disorder. Pharmacogenomics J. 2013 Jun;13(3):280-5. doi: 10.1038/tpj.2011.62. Epub 2012 Jan 17.

lead_sponsor: Eli Lilly and Company

location_country:
Portugal
Austria
Netherlands
Puerto Rico
United States
France
Germany

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

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 - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

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 recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

ReferenceCitation: Mesía R, Rivera F, Kawecki A, Rottey S, Hitt R, Kienzer H, Cupissol D, De Raucourt D, Benasso M, Koralewski P, Delord JP, Bokemeyer C, Curran D, Gross A, Vermorken JB. Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Ann Oncol. 2010 Oct;21(10):1967-1973. doi: 10.1093/annonc/mdq077. Epub 2010 Mar 24.

ReferenceCitation: Hecht M, Hahn D, Wolber P, Hautmann MG, Reichert D, Weniger S, Belka C, Bergmann T, Göhler T, Welslau M, Große-Thie C, Guntinas-Lichius O, von der Grün J, Balermpas P, Orlowski K, Messinger D, Stenzel KG, Fietkau R. Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer. BMC Cancer. 2020 Sep 29;20(1):933. doi: 10.1186/s12885-020-07440-w.

ReferenceCitation: Licitra L, Störkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Poland
Portugal
Spain
Italy
Austria
Netherlands
Russian Federation
United Kingdom
Czech Republic
Switzerland
Ukraine
Sweden
Hungary
France
Belgium
Germany
Slovakia


title: A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

summary: This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

ReferenceCitation: Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.

location_country:
Brazil
Hong Kong
Spain
Russian Federation
Australia
Argentina
Canada
Czech Republic
Finland
Sweden
Thailand
United States
Costa Rica
China
France
Mexico
Panama
Germany
South Africa


title: A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects

summary: This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

lead_sponsor: ViiV Healthcare

location_country:
Denmark
Portugal
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Germany


title: International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

summary:
The purpose of this study is to determine

whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms
whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

ReferenceCitation: O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F, Filippov V, Groth M, Knappertz V, Kraus C, Sandbrink R, Pohl C, Bogumil T; BEYOND Study Group, O'Connor P, Filippi M, Arnason B, Cook S, Goodin D, Hartung HP, Kappos L, Jeffery D, Comi G. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Oct;8(10):889-97. doi: 10.1016/S1474-4422(09)70226-1. Epub 2009 Sep 2. Erratum in: Lancet Neurol. 2009 Nov;8(11):981. Lancet Neurol. 2011 Feb;10(2):115. Lancet Neurol. 2012 Jan;11(1):27. Cree, B [added]; Harung, H-P [corrected to Hartung, H-P].

location_country:
Spain
Italy
Ukraine
United States
Belgium
Poland
Slovenia
Russian Federation
Austria
Australia
Argentina
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Ireland
Latvia
Finland
France
Netherlands


title: A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis

summary: This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Poland
Puerto Rico
Panama
Mexico
Sweden
Brazil
Hungary
Germany
Denmark
Taiwan
New Zealand
Finland
Czech Republic
Thailand
France


title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure

summary: The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

ReferenceCitation: Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Piña IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.

ReferenceCitation: Ter Maaten JM, Valente MA, Damman K, Cleland JG, Givertz MM, Metra M, O'Connor CM, Teerlink JR, Ponikowski P, Bloomfield DM, Cotter G, Davison B, Subacius H, van Veldhuisen DJ, van der Meer P, Hillege HL, Gheorghiade M, Voors AA. Combining Diuretic Response and Hemoconcentration to Predict Rehospitalization After Admission for Acute Heart Failure. Circ Heart Fail. 2016 Jun;9(6). pii: e002845. doi: 10.1161/CIRCHEARTFAILURE.115.002845.

ReferenceCitation: Ambrosy AP, Khan H, Udelson JE, Mentz RJ, Chioncel O, Greene SJ, Vaduganathan M, Subacuis HP, Konstam MA, Swedberg K, Zannad F, Maggioni AP, Gheorghiade M, Butler J. Changes in Dyspnea Status During Hospitalization and Postdischarge Health-Related Quality of Life in Patients Hospitalized for Heart Failure: Findings From the EVEREST Trial. Circ Heart Fail. 2016 May;9(5). pii: e002458. doi: 10.1161/CIRCHEARTFAILURE.115.002458.

ReferenceCitation: Mentz RJ, Greene SJ, Ambrosy AP, Vaduganathan M, Subacius HP, Swedberg K, Maggioni AP, Nodari S, Ponikowski P, Anker SD, Butler J, Gheorghiade M. Clinical profile and prognostic value of anemia at the time of admission and discharge among patients hospitalized for heart failure with reduced ejection fraction: findings from the EVEREST trial. Circ Heart Fail. 2014 May;7(3):401-8. doi: 10.1161/CIRCHEARTFAILURE.113.000840. Epub 2014 Apr 15.

ReferenceCitation: Hauptman PJ, Burnett J, Gheorghiade M, Grinfeld L, Konstam MA, Kostic D, Krasa HB, Maggioni A, Ouyang J, Swedberg K, Zannad F, Zimmer C, Udelson JE; Everest Investigators. Clinical course of patients with hyponatremia and decompensated systolic heart failure and the effect of vasopressin receptor antagonism with tolvaptan. J Card Fail. 2013 Jun;19(6):390-7. doi: 10.1016/j.cardfail.2013.04.001. Epub 2013 May 14.

ReferenceCitation: Ambrosy AP, Vaduganathan M, Mentz RJ, Greene SJ, Subačius H, Konstam MA, Maggioni AP, Swedberg K, Gheorghiade M. Clinical profile and prognostic value of low systolic blood pressure in patients hospitalized for heart failure with reduced ejection fraction: insights from the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST) trial. Am Heart J. 2013 Feb;165(2):216-25. doi: 10.1016/j.ahj.2012.11.004. Epub 2012 Dec 29.

ReferenceCitation: Allen LA, Gheorghiade M, Reid KJ, Dunlay SM, Chan PS, Hauptman PJ, Zannad F, Konstam MA, Spertus JA. Identifying patients hospitalized with heart failure at risk for unfavorable future quality of life. Circ Cardiovasc Qual Outcomes. 2011 Jul;4(4):389-98. doi: 10.1161/CIRCOUTCOMES.110.958009. Epub 2011 Jun 21.

ReferenceCitation: O'Connor CM, Miller AB, Blair JE, Konstam MA, Wedge P, Bahit MC, Carson P, Haass M, Hauptman PJ, Metra M, Oren RM, Patten R, Piña I, Roth S, Sackner-Bernstein JD, Traver B, Cook T, Gheorghiade M; Efficacy of Vasopressin Antagonism in heart Failure Outcome Study with Tolvaptan (EVEREST) investigators. Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: results from Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) program. Am Heart J. 2010 May;159(5):841-849.e1. doi: 10.1016/j.ahj.2010.02.023. Erratum in: Am Heart J. 2012 May;163(5):900.

ReferenceCitation: Blair JE, Zannad F, Konstam MA, Cook T, Traver B, Burnett JC Jr, Grinfeld L, Krasa H, Maggioni AP, Orlandi C, Swedberg K, Udelson JE, Zimmer C, Gheorghiade M; EVEREST Investigators. Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure results from the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) program. J Am Coll Cardiol. 2008 Nov 11;52(20):1640-8. doi: 10.1016/j.jacc.2008.07.056.

ReferenceCitation: Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials. JAMA. 2007 Mar 28;297(12):1332-43. Epub 2007 Mar 25.

ReferenceCitation: Konstam MA, Gheorghiade M, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007 Mar 28;297(12):1319-31. Epub 2007 Mar 25.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Brazil
Romania
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Argentina
Canada
Czech Republic
Switzerland
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Cardiology Research Institute of the Ministry of Health of the Russian Federation

location_facility: Cardiology Associates Covenant Medical Group

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: St. Petersburg Medical Postgraduate Academy

location_facility: Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto

location_facility: Hospital Santa Isabel da Santa Casa de Misericordia da Bahia

location_facility: Burdenko Main Military Clinical Hospital

location_facility: Central Arkansas Veterans Healthcare Systems

location_facility: Spitalul Clinic Universitar ,,Sf. Spiridon"

location_facility: University of Arkansas for Medical Sciences

location_facility: Institutul de Boli Cardiovasculare Timisoara

location_facility: Martini Ziekenhuis (Loc. Martini Paviljoen)

location_facility: The Heart and Vascular Institute of Florida

location_facility: Sint Lucas Andreas Ziekenhuis (loc. Lucas)

location_facility: St. Vincents Hospital and Medical Center

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Cardiopulmonary Research Science and Technology Institute

location_facility: Katedra i Klinika Chorab Wewnetrznych i Kardiologii

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Cardiovascular Consultants Medical Group, Inc.

location_facility: Santa Casa de Misericordia do Rio de Janeiro

location_facility: Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii

location_facility: Pitt County Memorial Hospital, The Heart Center

location_facility: University of Miami/ Jackson Memorial Hospital

location_facility: Jacksonville Center for Clinical Research

location_facility: Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)

location_facility: Scott & White Clinic Division of Cardiology

location_facility: Moscow State University of Medicine and Dentistry - City Hospital #40

location_facility: Cardiology Associates of North Mississippi

location_facility: Atlanta Heart and Vascular Research Group

location_facility: Cardiology Associates of Fort Lauderdale

location_facility: Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Interni klinika, Oddeleni Interna I, Kardiologie

location_facility: Heart and Vascular Clinic of North Colorado

location_facility: University of Texas Health Science Center

location_facility: Centre Hospitalier Universitaire de Nancy-Brabois

location_facility: Medisch Centrum Haaglanden (location Westeinde)

location_facility: Hjerte med. Avd. Haukeland Universitets Sykehus

location_facility: Herz- und Diabetes Zentrum Nordrhein-Westfalen

location_facility: Centre Hospitalier de l'Universite de Sherbrooke

location_facility: St. Petersburg Clinical Hospital of Russian Academy of Sciences

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Cabinet de Cardiologie et d'Explorations

location_facility: Moscow State University of Medicine and Dentistry - City Hospital #11

location_facility: Spitalul Judetean Brasov, Sectia de Cardiologie

location_facility: City Alexandrovsky Hospital, ICU Department

location_facility: IMC- Instituto de Molestias Cardiovasculares

location_facility: Buffalo Cardiology and Pulmonary Associates

location_facility: Moscow Regional Research Clinical Institute n.a. Vishnevsky

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Akademisches Lehrkrankenhaus d. HGS Essen

location_facility: Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Enheten for internmedicin, Karolinska Institutet

location_facility: Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Regional d'Arras-Service de Cardiologie

location_facility: Lousiana State University Health Sciences Center

location_facility: Poliambulatorio Valdichiana Ospedale di Cortona

location_facility: Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos

location_facility: Spitalul de Urgenta Floreasca, Clinica de Cardiologie

location_facility: University Health Network, Toronto Western Hospital

location_facility: St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care

location_facility: I. interni kardio-angiologicka klinika LF MU


title: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy (HERTHENA-Lung02)

summary: Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

status: Recruiting

study_completion_date_type: Anticipated

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Norway
Singapore
Canada
Switzerland
China
Germany
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Hackensack Meridian Health-Southern Ocean Medical Center

location_facility: National University Cancer Institute National University Hospital

location_facility: University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology

location_facility: Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio

location_facility: The First Affiliated Hospital of College of Medicine Zhejiang University

location_facility: Kantonsspital Graubuenden - Hauptstandort

location_facility: Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: IRCCS Istituto Oncologico Giovanni Paolo II

location_facility: Hospital Univeritario Marques de Valdecilla

location_facility: Fujian Medical University - Union Hospital Foochow Christian Union Hospital

location_facility: Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Kaiser Permanente - Vallejo Medical Center

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: The Second Affiliated Hospital of Kunming Medical University

location_facility: University Hospital Birmingham NHS Trust

location_facility: Harbin Medical University - Tumor Hospital The Third Affiliated Hospital

location_facility: Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: The First Affiliate Hospital of Xi'an Jiaotong University

location_facility: Instituto Portugues de Oncologio de Lisboa

location_facility: Fudan University - Shanghai Cancer Center FUSCC

location_facility: Saitama Medical University International Medical Center

location_facility: Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria

location_facility: Oslo University Hospital-The Norwegian Radium Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Sarah Cannon/Florida Cancer Specialists - FCS South

location_facility: University of Hong Kong/Queen Mary Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan University Hospital NTUH

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: Centro Hospitalar de Vila Nova de Gaia - Espinho

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: General Hospital of Eastern Theater Command

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The First Affiliated Hospital Sun-Yat-Sen University

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The Royal Marsden Hospital NHS Foundation Trust

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

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

status_simplified: Ongoing


title: CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

acronym: CYCLONE 3

summary: The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

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

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: The Center for Cancer and Blood Disorders

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

location_facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

location_facility: The First Afflilated Hospital of Bengbu Medical College

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: The Second Hospital of Tianjin Medical University

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Torrance Memorial Physician Network / Cancer Care

location_facility: Second Affiliated hospital of Anhui Medical University

location_facility: TriState Urologic Services DBA TUG Research

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Associated Medical Professionals - Urology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: The University of Vermont Medical Center Inc.

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: St. Antonius Ziekenhuis, locatie Utrecht

location_facility: University of Massachusetts Medical School

location_facility: The University of Louisville, James Graham Brown Cancer Center

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: InVO Institut für Versorgungsforschung in der Onkologie

location_facility: MemorialCare Health System - Long Beach Medical Center

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Army Medical Center of People's Liberation Army

location_facility: Centro Avançado de Tratamento Oncológico- CENANTRON

location_facility: Wannan Medical College Yijishan Hospital

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: Southern Medical University Nanfang Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Fundación Cenit Para La Investigación En Neurociencias

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

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

location_facility: Klinikum Rechts Der Isar Der Technischen Universität München

location_facility: Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

location_facility: Summit Cancer Care DBA Candler Medical Oncology Practice

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi

location_facility: Laura and Isaac Perlmutter Cancer Center

location_facility: Investigaciones Clinicas Moleculares (ICM)

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: West China Hospital of Sichuan University

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Urologicum Duisburg Fachärztesozietät - Walsum

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Xiangya Hospital Central South University

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi

location_facility: University General Hospital of Heraklion

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

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

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Centro de Investigacion Clinica de Oaxaca


title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (TITANIA)

acronym: TITANIA

summary: The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

lead_sponsor: AstraZeneca

location_country:
Poland
Taiwan
Brazil
Romania
United Kingdom
Greece
Italy
Australia
Russian Federation
Thailand
Philippines
Puerto Rico
United States
Chile
China
France
Colombia
Israel
Germany
Peru


acronym: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma

title: An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)

lead_sponsor: IO Biotech

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Hungary
United States
France
Israel
South Africa
Belgium
Germany
Czechia

location_facility: Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Hospital Regional Universitario de Malaga

location_facility: Department of Dermatology University of Mainz

location_facility: St. Josef Hospital - Ruhr-Universitt Bochum

location_facility: Hospital General Universitario de Valencia

location_facility: University of Kentucky Markey Cancer Center

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Hospital General Universitario Gregorio MaraÃ±on

location_facility: Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre

location_facility: Peter MacCallum Cancer Centre PMCC - East Melbourne

location_facility: Nationales Centrum fr Tumorerkrankungen NCT

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Bor, -Nemikortani es Onkodermatologiai Klinika

location_facility: Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden

location_facility: Mid Florida Hematology and Oncology Center

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan

location_facility: Centre Hospitalier Universitaire de Besançon Jean Minjoz

summary:
Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.

Patients will be stratified on the basis of the following factors; Disease stage: Unresectable stage IIID or stage IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type.

All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles corresponding to around 2 years of treatment. Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total, corresponding to around 2 years of treatment.

The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.