title: Translational Research - Observational Study for Identification of New Possible Prognostic Factors and Future Therapeutic Targets in Children With Acute Lymphoblastic Leukemia (ALL)

summary:
RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help the study of cancer in the future. Studying these samples in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is collecting and looking at blood and tissue samples in children with newly diagnosed acute lymphoblastic leukemia.

status: Unknown status

study_type: Observational

time_perspective: Other

ReferenceCitation: Matthijssens F, Sharma ND, Nysus M, Nickl CK, Kang H, Perez DR, Lintermans B, Van Loocke W, Roels J, Peirs S, Demoen L, Pieters T, Reunes L, Lammens T, De Moerloose B, Van Nieuwerburgh F, Deforce DL, Cheung LC, Kotecha RS, Risseeuw MD, Van Calenbergh S, Takarada T, Yoneda Y, van Delft FW, Lock RB, Merkley SD, Chigaev A, Sklar LA, Mullighan CG, Loh ML, Winter SS, Hunger SP, Goossens S, Castillo EF, Ornatowski W, Van Vlierberghe P, Matlawska-Wasowska K. RUNX2 regulates leukemic cell metabolism and chemotaxis in high-risk T cell acute lymphoblastic leukemia. J Clin Invest. 2021 Mar 15;131(6). pii: 141566. doi: 10.1172/JCI141566.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: France Portugal Belgium

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: CHRU de Besancon - Hopital Saint-Jacques

location_facility: Instituto Portugues De Oncologia - Centro Do Porto

location_facility: CHU de Toulouse - C.H.U. De Toulouse - Hopital Des Enfants

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: CHU de Reims - American Memorial Hospital

status_simplified: Unknown


type: EudraCT Number

title: A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

summary: This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

status: Terminated

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
New Zealand
Canada
United Kingdom
Puerto Rico
United States
France
Mexico
Germany
Slovakia

lead_sponsor_type: industriel


status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation

lead_sponsor: Shire

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.

ReferenceCitation: Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, Levine A. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation. Am J Gastroenterol. 2015 May;110(5):741-8. doi: 10.1038/ajg.2015.115. Epub 2015 Apr 14.

location_country:
Denmark
Poland
Romania
United Kingdom
Netherlands
France
Belgium
Germany
Bulgaria
Czechia

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Chirurgii Ogólnej i Gastroenterologii

location_facility: CHU - Hopital Nord, service gastro-enterologie et hepatologie

location_facility: County Durham & Darlington NHS Foundation Trust

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

location_facility: Hôpital Pontchaillou - Service des Maladies de l'Appareil Digestif

location_facility: Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Krajska Nemocnice T. Bati a.s., Interni oddeleni - klinika IPVZ; Nemocnicni Lekarna

location_facility: Hopital Avicenne, Centre d'exploitation fonctionnelle et reducation digestive

location_facility: Gastroenterologie und Hepatologie am Johannisplatz

location_facility: Service de Gastroenterologie & INSERM CIC-P 803 - CHU de Dijon

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Hopital Archet 2- service gastro-enterologie et hepatologie

location_facility: Instytut Medycyny Wsi im. Witolda Chodźki - Zaklad Endoskopowych Badań Kliniczncyh

location_facility: Spitalul Clinic Judetean Cluj,Clinica Medicala I

summary:
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.

Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.

status_simplified: Completed


title: A Phase III Trial of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant.

lead_sponsor: Pierre Fabre Medicament

ReferenceCitation: Martin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
South Africa
Belgium
Czechia
Poland
Russian Federation
Argentina
India
Mexico
Brazil
Switzerland
Hungary
Bulgaria
Taiwan
Belarus
Estonia
France

summary: The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.


title: A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000

summary: The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

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

lead_sponsor: Pfizer

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


title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

location_country:
Croatia
Spain
Italy
Lithuania
Ukraine
United States
Romania
Austria
Russian Federation
Norway
Sweden
Slovakia
Hungary
Germany
Taiwan
Latvia
Estonia
Finland
Czech Republic
Korea, Republic of
France

location_facility: 1245.24.701007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421108 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101025 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101024 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3310C Boehringer Ingelheim Investigational Site

location_facility: 1245.24.461001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3302B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101015 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491012 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821009 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371107 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3305B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101014 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701012 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.431001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.391003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.370101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101028 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.461005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.391006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381009 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.461004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701013 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3303B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491011 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101027 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701009 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101016 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.391005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421107 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886107 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701014 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3311B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.431002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101023 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.431003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.370102 Boehringer Ingelheim Investigational Site

summary: The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.


title: An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

lead_sponsor: Celgene

ReferenceType: background

ReferenceCitation: Hersh EM, Del Vecchio M, Brown MP, Kefford R, Loquai C, Testori A, Bhatia S, Gutzmer R, Conry R, Haydon A, Robert C, Ernst S, Homsi J, Grob JJ, Kendra K, Agarwala SS, Li M, Clawson A, Brachmann C, Karnoub M, Elias I, Renschler MF, Hauschild A. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Germany

location_facility: University of Arkansa for Medical Sciences

location_facility: Ist. Naz. per lo studio e la cura dei tumori G. Pascale

location_facility: Centre Regional Val d' Aurelle Paul Lamarque

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

location_facility: Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center

location_facility: McGill University Dept. of Oncology Clinical Research Program

location_facility: Univ. of Washington Medical Center/Seattle Cancer Care Alliance

location_facility: Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc

location_facility: Sydney West Cancer Trials Centre/Westmead Hospital

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: IST-Istituto Nazionale per la Ricera sul Cancro

location_facility: Groupe hospitalier Cochin-St. Vincent de Paul

location_facility: Singleton Hospital, Sothwest Wales Inst.

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: University of Southern California/Norris Cancer Center

location_facility: Centre Hospitaller Universitaire de Grenoble

location_facility: University of Miami Hospital and Clincs/SCCC

location_facility: OH State University Arthur G. James Cancer Hospital

location_facility: San Diego Pacific Oncology and Hematology Associates

summary: The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.


acronym: BRISK FL

title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.

ReferenceCitation: Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Aviña J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Poland
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
India
Turkey
Mexico
Sweden
Brazil
Canada
China
Germany
Taiwan
Czech Republic
Thailand
Korea, Republic of
France

location_facility: Agajanian Institute Of Hematology And Oncology

summary: The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.


acronym: ATMOSPHERE

title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Køber LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10:CD012569. doi: 10.1002/14651858.CD012569.pub2.

ReferenceCitation: Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rørth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.

ReferenceCitation: Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Böhm M, Desai AS, Dickstein K, Køber LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.

ReferenceCitation: Dewan P, Rørth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Køber L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum in: Circ Heart Fail. 2020 Jan;13(1):e000036.

ReferenceCitation: Shen L, Ramires F, Martinez F, Bodanese LC, Echeverría LE, Gómez EA, Abraham WT, Dickstein K, Køber L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11). pii: e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.

ReferenceCitation: Kristensen SL, Jhund PS, Mogensen UM, Rørth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10). pii: e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.

ReferenceCitation: Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Køber L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.

ReferenceCitation: McMurray JJ, Krum H, Abraham WT, Dickstein K, Køber LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.

location_country:
Spain
Italy
United Kingdom
Lithuania
Venezuela
United States
Costa Rica
Peru
Belgium
Japan
Romania
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Dominican Republic
Greece
Estonia
Ireland
Finland
Czech Republic
Latvia
Thailand
Korea, Republic of
France
Colombia
Netherlands

summary: The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.


acronym: ENDORSE

title: A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

lead_sponsor: Biogen

ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020. Erratum in: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Austria
Australia
Puerto Rico
India
Israel
Mexico
Slovakia
Bosnia and Herzegovina
Canada
Switzerland
North Macedonia
Germany
Bulgaria
Moldova, Republic of
Belarus
Greece
Ireland
Estonia
Latvia
New Zealand
France
Netherlands

location_facility:
Research Site
research Site

summary: The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.


title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

lead_sponsor: Bayer

ReferenceType: result

ReferenceCitation: Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684.

ReferenceCitation: Ghofrani HA, Galiè N, Grimminger F, Grünig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

ReferenceCitation: Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

ReferenceCitation: Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2. Review.

ReferenceCitation: Benza RL, Ghofrani HA, Grünig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

ReferenceCitation: Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Ireland
New Zealand
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).


title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

summary: This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

ReferenceCitation: Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.

ReferenceCitation: Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.

location_country:
Poland
Taiwan
Brazil
Hong Kong
Spain
Greece
Italy
Australia
Russian Federation
Argentina
Canada
Czech Republic
Thailand
United Kingdom
Hungary
France
Israel
Belgium
Germany
Bulgaria


primary_purpose: Prevention

title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment

ReferenceCitation: Macìas G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol. 2013 Aug;33(6):591-6. doi: 10.3109/01443615.2013.800851.

location_country:
Spain
United Kingdom
Australia
Finland
Thailand
Switzerland
France
Mexico
Germany

summary: The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).


acronym: REALISTIC

intervention_type: Other

title: A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.

lead_sponsor: UCB Pharma

ReferenceCitation: Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.

ReferenceCitation: Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.

ReferenceCitation: Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.

location_country:
Spain
Italy
Netherlands
Canada
United States
France
Germany

summary: This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.


title: A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

summary: The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

ReferenceCitation: Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.

ReferenceCitation: Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.

ReferenceCitation: Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovàcs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.

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


title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

acronym: BELIEVE

summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

ReferenceCitation: Paul C, van de Kerkhof P, Puig L, Unnebrink K, Goldblum O, Thaçi D. Influence of psoriatic arthritis on the efficacy of adalimumab and on the treatment response of other markers of psoriasis burden: subanalysis of the BELIEVE study. Eur J Dermatol. 2012 Nov-Dec;22(6):762-9. doi: 10.1684/ejd.2012.1863.

lead_sponsor: Abbott

location_country:
Denmark
Spain
Greece
Austria
Italy
Netherlands
Finland
Czech Republic
Switzerland
United Kingdom
Sweden
France
Turkey
Belgium
Germany

intervention_type: Biological


title: A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib Versus Lapatinib Monotherapy in Patients With ErbB2 Over-expressing Inflammatory Breast Cancer

summary: The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Philippines
Belgium
Hong Kong
Russian Federation
Australia
Tunisia
Israel
Turkey
Singapore
Egypt
Canada
China
Germany
Taiwan
Greece
Czech Republic
Thailand
Korea, Republic of
France
Chile
Morocco
Pakistan


title: A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)

ReferenceCitation: Chan DL, Yao JC, Carnaghi C, Buzzoni R, Herbst F, Ridolfi A, Strosberg J, Kulke MH, Pavel M, Singh S. Markers of Systemic Inflammation in Neuroendocrine Tumors: A Pooled Analysis of the RADIANT-3 and RADIANT-4 Studies. Pancreas. 2021 Feb 1;50(2):130-137. doi: 10.1097/MPA.0000000000001745.

ReferenceCitation: Yao JC, Voi M, Lincy J, Pavel M. Reply to V. Amoroso et al. J Clin Oncol. 2017 May 1;35(13):1488-1489. doi: 10.1200/JCO.2017.71.3875. Epub 2017 Jan 23.

ReferenceCitation: Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Öberg K. Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. doi: 10.1200/JCO.2016.68.0702. Epub 2016 Sep 30.

ReferenceCitation: Lombard-Bohas C, Yao JC, Hobday T, Van Cutsem E, Wolin EM, Panneerselvam A, Stergiopoulos S, Shah MH, Capdevila J, Pommier R. Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors: a subgroup analysis of the phase III RADIANT-3 trial. Pancreas. 2015 Mar;44(2):181-9. doi: 10.1097/MPA.0000000000000262.

ReferenceCitation: Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Öberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.

location_country:
Taiwan
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
Thailand
Switzerland
Sweden
Korea, Republic of
France
United States
Belgium
Japan
Germany
Slovakia

location_facility: The Center for Cancer and Blood Disorders

location_facility: University of Louisville / James Graham Brown Cancer Center SC

location_facility: Littleton Regional Hospital Dept. of Hematology/Oncology

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Dept. of Neuroendocrine Clinic

location_facility: University of Pittsburgh Medical Center Hillman Cancer Center

location_facility: Oregon Health & Science University Dept. of OHSU (3)

location_facility: Columbia University Medical Center- New York Presbyterian Dept. of Columbia Med. Center

location_facility: Kaiser Permanente Northwest Franklin Medical Offices

location_facility: University of California San Francisco Dept. of UCSF Comp. Cancer

location_facility: University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)

location_facility: H. Lee Moffitt Cancer Center & Research Institute Malignant Hematology Clinic

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

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson CancerCent

location_facility: University of Iowa Medical Center Dept. of Iowa Medical Center

location_facility: University of California at Los Angeles UCLA (3)

location_facility: Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (4)

location_facility: Indiana University Health Goshen Center for Cancer Dept. of Indiana Univ. Cancer

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept. of OHSU Medical Center

summary: The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.


title: A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

summary:
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

lead_sponsor: Sprout Pharmaceuticals, Inc

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Czech Republic
Sweden
Hungary
France
Belgium
Norway
Germany

location_facility: 511.77.31009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3303A Boehringer Ingelheim Investigational Site

location_facility: 511.77.42004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3311A Boehringer Ingelheim Investigational Site

location_facility: 511.77.35801 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3308A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44010 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3310A Boehringer Ingelheim Investigational Site

location_facility: 511.77.35805 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3301A Boehringer Ingelheim Investigational Site

location_facility: 511.77.43004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3306A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44011 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35804 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3312A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35802 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3314A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.39001 IRCCS S. Fondazione Maugeri

location_facility: 511.77.46005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3305A Boehringer Ingelheim Investigational Site

location_facility: 511.77.3302A Boehringer Ingelheim Investigational Site

location_facility: 511.77.49008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35803 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43005 Boehringer Ingelheim Investigational Site


acronym: DASISION

title: An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

ReferenceCitation: Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.

ReferenceCitation: Hughes TP, Saglio G, Quintás-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.

ReferenceCitation: Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.

ReferenceCitation: Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boqué C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

ReferenceCitation: Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipiña JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.

ReferenceCitation: Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boqué C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.

location_country:
Spain
Italy
United States
Peru
Belgium
Japan
Poland
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Singapore
Brazil
Hungary
China
Germany
Denmark
Greece
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Local Institution
Molecular Md

summary: The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.


acronym: NEXUS

title: A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

ReferenceCitation: Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, Bennouna J, Zhang L, Liao M, Sun Y, Gans S, Syrigos K, Le Marie E, Gottfried M, Vansteenkiste J, Alberola V, Strauss UP, Montegriffo E, Ong TJ, Santoro A; NSCLC [non-small-cell lung cancer] Research Experience Utilizing Sorafenib (NExUS) Investigators Study Group. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer. J Clin Oncol. 2012 Sep 1;30(25):3084-92. doi: 10.1200/JCO.2011.39.7646. Epub 2012 Jul 30.

location_country:
Brazil
Spain
Greece
Austria
Italy
Mexico
Canada
Finland
Netherlands
Switzerland
United Kingdom
Hungary
France
Israel
China
Belgium
Germany
Cyprus

summary: Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)


acronym: RADIANT

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

lead_sponsor: OSI Pharmaceuticals

ReferenceCitation: Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crinò L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.

location_country:
Poland
Taiwan
Romania
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
Czech Republic
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Cancer Care Centers of South Texas-HOAST

location_facility: Gachon Medical School Ghil Medical Center

location_facility: Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport

location_facility: University of Chicago, Section of Hematology/Oncology

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika

location_facility: University of Arkansas for Medical Science

location_facility: "Papageorgiou" General Hospital of Thessaloniki

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"

location_facility: CHU - Hopital Pontchaillou - Service de pneumologie

location_facility: CHU Larrey Service de Pneumologie, Clinique des voies respiratoires

location_facility: Univ. of Washington/ Seattle Cancer Care Alliance

location_facility: The New York Presbyterian-Weill Medical College of Cornell University

location_facility: State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care

location_facility: St. Joseph Medical Center's Cancer Institute

location_facility: University of California, San Francisco Comprehensive Cancer Center

location_facility: Heartland Regional Medical Center d/b/a Heartland Clinic

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta

location_facility: Aultman Hospital/ North Canton Medical Foundation

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie

location_facility: Hospital General Universitario de Valencia

location_facility: Istituto Nazionale per la Ricerca e la Cura del Cancro

location_facility: Hospital de Rehabilitación Respiratoria María Ferrer

location_facility: Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: RS MacLaughlin Durham Regional Cancer Centre

location_facility: Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

location_facility: Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: "G. Papanikolaou" General Hospital of Thessaloniki

location_facility: State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4

location_facility: SMZ Baumgartner Hoehe - Otto Wagner Spital

location_facility: Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"

location_facility: Severance Hospital, Yonsei Univ. College of Medicine

location_facility: Texas Oncology Texas Cancer Center at Medical City

location_facility: Országos Korányi TBC és Pulmonológiai Intézet

location_facility: Cancer Care Associates - Medical Oncology

location_facility: Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag

location_facility: Centre d'Oncologie et de Radiothérapie du Pays Basque

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: St James' Institute of Oncology, Bexley Wing, St James' University Hospital

location_facility: FN Bulovka Klinika plincni a hrrudni chirurgie

location_facility: State Healthcare Institution "Regional Clinical Oncology Dispensary"

location_facility: Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: SMZ Baumgartner Höhe - Otto- Wagner-Spital

location_facility: Stronach Regional cancer Centre at Southlake

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

location_facility: Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci

location_facility: Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego

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

location_facility: State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"

location_facility: C.H.U. Morvan, Institut de Cancerologie et d'Hématologie

location_facility: Azienda Ospedaliero- Universitaria di Parma

location_facility: Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: The Royal Surrey County Hospital NHS Trust

location_facility: Städtisches Krankenhaus Martha-Maria, Halle-Dölau

location_facility: University of New Mexico Health Science Center

location_facility: Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care

location_facility: Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"

location_facility: Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza

location_facility: The Hospital of the University of Pennsylvania

location_facility: Christus St. Vincent Regional Cancer Center

location_facility: Thunder Bay Regional Health Science Centre

location_facility: Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"

location_facility: Cancer Care Centers of South Texas - HOAST

location_facility: Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie

location_facility: Cancer Center of Southeastern Ontario at Kingston General Hospital

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie

location_facility: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej

location_facility: Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II

location_facility: Hopital De La Croix-Rousse Service de Pneumologie

location_facility: Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina

summary: This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.


title: A Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose

summary: This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

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:
Denmark
Poland
Spain
Italy
Latvia
Russian Federation
Lithuania
Sweden
France
Belgium
Norway
Netherlands


title: A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

summary: Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

ReferenceCitation: Ansquer JC, Bekaert I, Guy M, Hanefeld M, Simon A; Study Investigators. Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Am J Cardiovasc Drugs. 2009;9(2):91-101. doi: 10.2165/00129784-200909020-00003.

lead_sponsor: Solvay Pharmaceuticals

location_country: Germany France Belgium

location_facility:
Site 309
Site 304
Site 206
Site 113
Site 115
Site 104
Site 208
Site 102
Site 112
Site 306
Site 311
Site 314
Site 305
Site 301
Site 205
Site 110
Site 103
Site 107
Site 106
Site 307
Site 313
Site 213
Site 312
Site 302
Site 101
Site 116
Site 210
Site 114
Site 303
Site 207
Site 308
Site 310
Site 211
Site 212
Site 202
Site 105
Site 209
Site 109
Site 201
Site 204
Site 108
Site 203
Site 111


title: A 54 Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE4-stratified Subjects With Mild to Moderate Alzheimer's Disease

summary:
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606.

location_country:
Spain
United Kingdom
United States
Belgium
Philippines
South Africa
Czechia
Poland
Hong Kong
Slovenia
Australia
Sweden
Malaysia
Singapore
Slovakia
Canada
Germany
Bulgaria
Finland
Korea, Republic of
France
Netherlands


title: RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

summary: The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

ReferenceCitation: Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.

location_country:
Spain
Italy
Lithuania
United States
Belgium
South Africa
Poland
Austria
Australia
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Greece
Finland
Czech Republic
France
Chile
Colombia
Netherlands


title: The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

acronym: TNT

summary: The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.

ReferenceCitation: Waters DD, LaRosa JC, Barter P, Fruchart JC, Gotto AM Jr, Carter R, Breazna A, Kastelein JJ, Grundy SM. Effects of high-dose atorvastatin on cerebrovascular events in patients with stable coronary disease in the TNT (treating to new targets) study. J Am Coll Cardiol. 2006 Nov 7;48(9):1793-9. Epub 2006 Oct 17.

ReferenceCitation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.

ReferenceCitation: Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD. Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004724. doi: 10.1161/CIRCOUTCOMES.118.004724.

ReferenceCitation: Kaasenbrood L, Ray KK, Boekholdt SM, Smulders YM, LaRosa JC, Kastelein JJP, van der Graaf Y, Dorresteijn JAN, Visseren FLJ. Estimated individual lifetime benefit from PCSK9 inhibition in statin-treated patients with coronary artery disease. Heart. 2018 Oct;104(20):1699-1705. doi: 10.1136/heartjnl-2017-312510. Epub 2018 Apr 5.

ReferenceCitation: Vallejo-Vaz AJ, Fayyad R, Boekholdt SM, Hovingh GK, Kastelein JJ, Melamed S, Barter P, Waters DD, Ray KK. Triglyceride-Rich Lipoprotein Cholesterol and Risk of Cardiovascular Events Among Patients Receiving Statin Therapy in the TNT Trial. Circulation. 2018 Aug 21;138(8):770-781. doi: 10.1161/CIRCULATIONAHA.117.032318.

ReferenceCitation: Ong KL, Waters DD, Fayyad R, Vogt L, Melamed S, DeMicco DA, Rye KA, Barter PJ. Relationship of High-Density Lipoprotein Cholesterol With Renal Function in Patients Treated With Atorvastatin. J Am Heart Assoc. 2018 Jan 22;7(2). pii: e007387. doi: 10.1161/JAHA.117.007387.

ReferenceCitation: Ports WC, Fayyad R, DeMicco DA, Laskey R, Wolk R. Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis. Clin Drug Investig. 2017 Aug;37(8):775-785. doi: 10.1007/s40261-017-0533-0.

ReferenceCitation: Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.

ReferenceCitation: Stam-Slob MC, van der Graaf Y, Greving JP, Dorresteijn JA, Visseren FL. Cost-Effectiveness of Intensifying Lipid-Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients. J Am Heart Assoc. 2017 Feb 18;6(2). pii: e004648. doi: 10.1161/JAHA.116.004648.

ReferenceCitation: Deedwania PC, Pedersen TR, DeMicco DA, Breazna A, Betteridge DJ, Hitman GA, Durrington P, Neil A; TNT, CARDS and IDEAL Steering Committees and Investigators. Differing predictive relationships between baseline LDL-C, systolic blood pressure, and cardiovascular outcomes. Int J Cardiol. 2016 Nov 1;222:548-556. doi: 10.1016/j.ijcard.2016.07.201. Epub 2016 Jul 30.

ReferenceCitation: Byun YS, Lee JH, Arsenault BJ, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; TNT Trial Investigators. Relationship of oxidized phospholipids on apolipoprotein B-100 to cardiovascular outcomes in patients treated with intensive versus moderate atorvastatin therapy: the TNT trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1286-1295. doi: 10.1016/j.jacc.2015.01.050.

ReferenceCitation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; Treating to New Targets (TNT) Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients of the treating to new targets randomized controlled trial by lipid and non-lipid biomarkers. PLoS One. 2014 Dec 22;9(12):e114519. doi: 10.1371/journal.pone.0114519. eCollection 2014.

ReferenceCitation: Dorresteijn JA, Boekholdt SM, van der Graaf Y, Kastelein JJ, LaRosa JC, Pedersen TR, DeMicco DA, Ridker PM, Cook NR, Visseren FL. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect. Circulation. 2013 Jun 25;127(25):2485-93. doi: 10.1161/CIRCULATIONAHA.112.000712. Epub 2013 May 14.

ReferenceCitation: Semb AG, Kvien TK, DeMicco DA, Fayyad R, Wun CC, LaRosa JC, Betteridge J, Pedersen TR, Holme I. Effect of intensive lipid-lowering therapy on cardiovascular outcome in patients with and those without inflammatory joint disease. Arthritis Rheum. 2012 Sep;64(9):2836-46. doi: 10.1002/art.34524.

ReferenceCitation: Huijgen R, Boekholdt SM, Arsenault BJ, Bao W, Davaine JM, Tabet F, Petrides F, Rye KA, DeMicco DA, Barter PJ, Kastelein JJ, Lambert G. Plasma PCSK9 levels and clinical outcomes in the TNT (Treating to New Targets) trial: a nested case-control study. J Am Coll Cardiol. 2012 May 15;59(20):1778-84. doi: 10.1016/j.jacc.2011.12.043. Retraction in: J Am Coll Cardiol. 2013 Apr 23;61(16):1751.

ReferenceCitation: Mora S, Wenger NK, Demicco DA, Breazna A, Boekholdt SM, Arsenault BJ, Deedwania P, Kastelein JJ, Waters DD. Determinants of residual risk in secondary prevention patients treated with high- versus low-dose statin therapy: the Treating to New Targets (TNT) study. Circulation. 2012 Apr 24;125(16):1979-87. doi: 10.1161/CIRCULATIONAHA.111.088591. Epub 2012 Mar 29.

ReferenceCitation: Arsenault BJ, Boekholdt SM, Hovingh GK, Hyde CL, DeMicco DA, Chatterjee A, Barter P, Deedwania P, Waters DD, LaRosa JC, Pedersen TR, Kastelein JJ; TNT and IDEAL Investigators. The 719Arg variant of KIF6 and cardiovascular outcomes in statin-treated, stable coronary patients of the treating to new targets and incremental decrease in end points through aggressive lipid-lowering prospective studies. Circ Cardiovasc Genet. 2012 Feb 1;5(1):51-7. doi: 10.1161/CIRCGENETICS.111.960252. Epub 2011 Dec 1.

ReferenceCitation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; TNT Study Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients by lipid and nonlipid biomarkers. J Am Coll Cardiol. 2011 Jan 4;57(1):63-9. doi: 10.1016/j.jacc.2010.06.052. Retraction in: J Am Coll Cardiol. 2013 Apr 23;61(16):1750.

ReferenceCitation: Hyde CL, Macinnes A, Sanders FA, Thompson JF, Mazzarella RA, Faergeman O, van Wijk DF, Wood L, Lira M, Paciga SA. Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients. Circ Cardiovasc Genet. 2010 Apr;3(2):162-8. doi: 10.1161/CIRCGENETICS.109.897793. Epub 2010 Feb 3.

ReferenceCitation: Waters DD. Clinical insights from the Treating to New Targets trial. Prog Cardiovasc Dis. 2009 May-Jun;51(6):487-502. doi: 10.1016/j.pcad.2009.01.001.

ReferenceCitation: Shepherd J, Kastelein JP, Bittner VA, Carmena R, Deedwania PC, Breazna A, Dobson S, Wilson DJ, Zuckerman AL, Wenger NK; Treating to New Targets Steering Committee and Investigators. Intensive lipid lowering with atorvastatin in patients with coronary artery disease, diabetes, and chronic kidney disease. Mayo Clin Proc. 2008 Aug;83(8):870-9.

ReferenceCitation: Shah SJ, Waters DD, Barter P, Kastelein JJ, Shepherd J, Wenger NK, DeMicco DA, Breazna A, LaRosa JC. Intensive lipid-lowering with atorvastatin for secondary prevention in patients after coronary artery bypass surgery. J Am Coll Cardiol. 2008 May 20;51(20):1938-43. doi: 10.1016/j.jacc.2007.12.054.

ReferenceCitation: Shepherd J, Kastelein JJ, Bittner V, Deedwania P, Breazna A, Dobson S, Wilson DJ, Zuckerman A, Wenger NK; TNT (Treating to New Targets) Investigators. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1448-54. doi: 10.1016/j.jacc.2007.11.072.

ReferenceCitation: Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10.

location_country:
Spain
Ireland
Austria
Australia
Italy
Canada
Netherlands
Switzerland
United Kingdom
United States
France
South Africa
Belgium
Germany


title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria

acronym: PLANET 1

summary: The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

ReferenceCitation: de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.

lead_sponsor: AstraZeneca

location_country:
Denmark
Brazil
Romania
Italy
Argentina
Canada
Hungary
United States
France
Mexico
Bulgaria

location_facility:
Research site
Research Site
Reasearch Site


title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).

summary:
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

design_allocation: Non-Randomized

location_country: Poland Finland Switzerland France Belgium Bulgaria


title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

ReferenceCitation: Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

lead_sponsor: Novo Nordisk A/S

location_country:
United Kingdom
Ireland
Austria
United States
France
Belgium
Germany


title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone

summary: This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

location_country:
Spain
United Kingdom
Australia
Vietnam
Philippines
Korea, Republic of
France
Israel
South Africa
Norway


title: A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS

summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

ReferenceCitation: Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15.

ReferenceCitation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17.

ReferenceCitation: Kirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.

ReferenceCitation: Griffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13.

ReferenceCitation: Gniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31.

ReferenceCitation: Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.

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

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Belgium
Czechia
Poland
Portugal
Austria
Australia
Argentina
Turkey
Mexico
Sweden
Switzerland
Former Serbia and Montenegro
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Colombia
Netherlands

location_facility: Guy's and St. Thomas' Trust St.Thomas' Hospital

location_facility: University of Athens Andreas Syngros Hospital Athens, Greece

location_facility: Klinikum Innenstadt der Universitaet Muenchen

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centro Integral de Reumatologia del Caribe S.A.S

location_facility: Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: The Royal Free Hospital, Pond Street, Hampstead

location_facility: Policlinico Umberto I - Universita La Sapienza

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum

location_facility: Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm

location_facility: Semmelweis University - Faculty of Health Sciences

location_facility: University of Copenhagen - Roskilde Hospital

location_facility: Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052

location_facility: Clinic for Dermatology and Clinic for Medical Rehabilitation


title: A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload

summary: This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

ReferenceCitation: Porter JB, El-Alfy M, Viprakasit V, Giraudier S, Chan LL, Lai Y, El-Ali A, Han J, Cappellini MD. Utility of labile plasma iron and transferrin saturation in addition to serum ferritin as iron overload markers in different underlying anemias before and after deferasirox treatment. Eur J Haematol. 2016 Jan;96(1):19-26. doi: 10.1111/ejh.12540. Epub 2015 Jun 23.

ReferenceCitation: Lee JW, Yoon SS, Shen ZX, Ganser A, Hsu HC, El-Ali A, Habr D, Martin N, Porter JB. Hematologic responses in patients with aplastic anemia treated with deferasirox: a post hoc analysis from the EPIC study. Haematologica. 2013 Jul;98(7):1045-8. doi: 10.3324/haematol.2012.077669. Epub 2013 Apr 12.

ReferenceCitation: Pennell DJ, Porter JB, Cappellini MD, Chan LL, El-Beshlawy A, Aydinok Y, Ibrahim H, Li CK, Viprakasit V, Elalfy MS, Kattamis A, Smith G, Habr D, Domokos G, Roubert B, Taher A. Continued improvement in myocardial T2* over two years of deferasirox therapy in β-thalassemia major patients with cardiac iron overload. Haematologica. 2011 Jan;96(1):48-54. doi: 10.3324/haematol.2010.031468. Epub 2010 Nov 11.

ReferenceCitation: Lee JW, Yoon SS, Shen ZX, Ganser A, Hsu HC, Habr D, Domokos G, Roubert B, Porter JB; EPIC study investigators. Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial. Blood. 2010 Oct 7;116(14):2448-54. doi: 10.1182/blood-2010-01-261289. Epub 2010 Jun 21.

ReferenceCitation: Pennell DJ, Porter JB, Cappellini MD, El-Beshlawy A, Chan LL, Aydinok Y, Elalfy MS, Sutcharitchan P, Li CK, Ibrahim H, Viprakasit V, Kattamis A, Smith G, Habr D, Domokos G, Roubert B, Taher A. Efficacy of deferasirox in reducing and preventing cardiac iron overload in beta-thalassemia. Blood. 2010 Mar 25;115(12):2364-71. doi: 10.1182/blood-2009-04-217455. Epub 2009 Dec 8.

ReferenceCitation: Cappellini MD, Porter J, El-Beshlawy A, Li CK, Seymour JF, Elalfy M, Gattermann N, Giraudier S, Lee JW, Chan LL, Lin KH, Rose C, Taher A, Thein SL, Viprakasit V, Habr D, Domokos G, Roubert B, Kattamis A; EPIC Study Investigators. Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias. Haematologica. 2010 Apr;95(4):557-66. doi: 10.3324/haematol.2009.014696. Epub 2009 Nov 30.

location_country:
Spain
Italy
United Kingdom
Belgium
South Africa
Hong Kong
Austria
Australia
Israel
Turkey
Malaysia
Egypt
Lebanon
Switzerland
China
Germany
Denmark
Taiwan
Greece
Thailand
Korea, Republic of
France
Netherlands


title: Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis

summary: This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.

ReferenceCitation: Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

location_country:
Denmark
Poland
Taiwan
Hong Kong
Spain
Italy
Austria
United Kingdom
Finland
Czech Republic
France
Germany


title: A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

summary: This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).

ReferenceCitation: Khawaja MN, Bergman MJ, Yourish J, Pei J, Reiss W, Keystone E. Routine Assessment of Patient Index Data 3 and the American College of Rheumatology/European League Against Rheumatism Provisional Remission Definitions as Predictors of Radiographic Outcome in a Rheumatoid Arthritis Clinical Trial With Tocilizumab. Arthritis Care Res (Hoboken). 2017 May;69(5):609-615. doi: 10.1002/acr.23008. Epub 2017 Apr 7.

ReferenceCitation: Kremer JM, Blanco R, Halland AM, Brzosko M, Burgos-Vargas R, Mela CM, Rowell L, Fleischmann RM. Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial. Clin Exp Rheumatol. 2016 Jul-Aug;34(4):625-33. Epub 2016 Apr 15.

ReferenceCitation: Bay-Jensen AC, Platt A, Siebuhr AS, Christiansen C, Byrjalsen I, Karsdal MA. Early changes in blood-based joint tissue destruction biomarkers are predictive of response to tocilizumab in the LITHE study. Arthritis Res Ther. 2016 Jan 20;18:13. doi: 10.1186/s13075-015-0913-x.

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: Siebuhr AS, Bay-Jensen AC, Leeming DJ, Plat A, Byrjalsen I, Christiansen C, van de Heijde D, Karsdal MA. Serological identification of fast progressors of structural damage with rheumatoid arthritis. Arthritis Res Ther. 2013 Aug 14;15(4):R86. doi: 10.1186/ar4266.

ReferenceCitation: Fleischmann RM, Halland AM, Brzosko M, Burgos-Vargas R, Mela C, Vernon E, Kremer JM. Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol. 2013 Feb;40(2):113-26. doi: 10.3899/jrheum.120447. Epub 2013 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: Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-21. doi: 10.1002/art.30158.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Brazil
Spain
Greece
Italy
Australia
Finland
Switzerland
Puerto Rico
United States
France
China
South Africa
Mexico
Norway