summary: This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

repository_institution: Imperial College London - Spiral

repository_institution: University of Dundee - Discovery Research Portal

repositories_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.

ReferenceCitation: Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7.

ReferenceCitation: Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8.

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of Cambridge - Apollo

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title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Turkey
France
Hungary
Denmark
Ukraine
Tunisia
Belgium
China
Philippines
Italy
United Kingdom
Netherlands
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation


study_start_date_type: Actual

acronym: AFFIRM

intervention_type: Drug

lead_sponsor: Pfizer

summary: This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

ReferenceType: derived

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.

version: acceptedVersion

publisher_dissemination: Elsevier

ReferenceCitation: Zhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.

ReferenceCitation: Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

ReferenceCitation: Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21. Erratum In: Clin Genitourin Cancer. 2019 Jun;17(3):240.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

ReferenceCitation: Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.

ReferenceCitation: Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.

ReferenceCitation: Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.

ReferenceCitation: Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4. Erratum In: Lancet Oncol. 2014 Oct;15(11):e475.

ReferenceCitation: Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.

sponsor_collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

location_facility: University of Colorado Denver, Anschutz Cancer Pavilion

location_facility: Stanford Hospital and Clinics Research Pharmacy

location_facility: University of Pittsburgh Cancer Institute

location_facility: Centre Regional Francois Baclesse de lutte contre le cancer

location_facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin

location_facility: Clinica Universitaria Privada Reina Fabiola

location_facility: Prince of Wales Hospital, Department of Medical Oncology

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie

location_facility: Nevada Cancer Institute, an affiliate of the UC San Diego Health System

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Instituto de Investigaciones Clinicas Cipolletti

location_facility: Centre de rechereche clinique et evaluative en oncologie

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: Wojewodzki szpital specjalistyczny im. Janusza Korczaka

location_facility: Abt.f.Diagnostische u. Interventionelle Radiologie

location_facility: Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Groupement Hospitalier Edouard Herriot - Pavillon V

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie

location_facility: Sir Charles Gairdner Hospital, Department of Medical Oncology

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Tom Baker Cancer Centre - Holy Cross Site

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

location_facility: Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Washington University School of Medicine

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)

location_facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Sydney West Cancer Trials Centre, Department of Medical Oncology

location_facility: Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin

location_facility: British Columbia Cancer Agency, Centre for the Southern Interior

location_facility: Instituto de Oncologia y Especialidades Medicas

location_facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: George Washington University-Medical Faculty Associates

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Hospital of the University of Pennsylvania

location_facility: North County Oncology Medical Clinic, Inc,

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Centre Hospitalier Intercommunal Frejus-Saint Raphael

location_facility: University of Wisconsin Hospital and Clinics

title: Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Netherlands
Austria
Belgium
United States
Spain
South Africa
Chile
Canada
France


title: A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea

summary: The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_country:
Finland
Germany
Italy
Portugal
United Kingdom
Argentina
Romania
Sweden
Netherlands
Mexico
Belgium
Korea, Republic of
Spain
Greece
Estonia
Puerto Rico
Russian Federation
France

lead_sponsor_type: industriel

status_simplified: Completed


acronym: The COMFORT-II Trial

lead_sponsor: Novartis Pharmaceuticals

summary: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

ReferenceCitation: Verstovsek S, Gotlib J, Mesa RA, Vannucchi AM, Kiladjian JJ, Cervantes F, Harrison CN, Paquette R, Sun W, Naim A, Langmuir P, Dong T, Gopalakrishna P, Gupta V. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017 Sep 29;10(1):156. doi: 10.1186/s13045-017-0527-7.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_concat: PubMed Central;localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

unpaywall_oa_status: gold

ReferenceCitation: McMullin MF, Harrison CN, Niederwieser D, Demuynck H, Jakel N, Gopalakrishna P, McQuitty M, Stalbovskaya V, Recher C, Theunissen K, Gisslinger H, Kiladjian JJ, Al-Ali HK. The use of erythropoiesis-stimulating agents with ruxolitinib in patients with myelofibrosis in COMFORT-II: an open-label, phase 3 study assessing efficacy and safety of ruxolitinib versus best available therapy in the treatment of myelofibrosis. Exp Hematol Oncol. 2015 Sep 15;4:26. doi: 10.1186/s40164-015-0021-2. eCollection 2015.

repository_institution: Queen's University Belfast - Research Portal

repositories_concat: PubMed Central;pure.qub.ac.uk/portal

ReferenceCitation: Vannucchi AM, Kantarjian HM, Kiladjian JJ, Gotlib J, Cervantes F, Mesa RA, Sarlis NJ, Peng W, Sandor V, Gopalakrishna P, Hmissi A, Stalbovskaya V, Gupta V, Harrison C, Verstovsek S; COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015 Sep;100(9):1139-45. doi: 10.3324/haematol.2014.119545. Epub 2015 Jun 11.

repository_institution: University of Florence - Florence Research

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Cervantes F, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Sirulnik A, Stalbovskaya V, McQuitty M, Hunter DS, Levy RS, Passamonti F, Barbui T, Barosi G, Harrison CN, Knoops L, Gisslinger H; COMFORT-II investigators. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013 Dec 12;122(25):4047-53. doi: 10.1182/blood-2013-02-485888. Epub 2013 Oct 30. Erratum In: Blood. 2016 Dec 22;128(25):3013.

oa_colors: green other

ReferenceCitation: Wilkins BS, Radia D, Woodley C, Farhi SE, Keohane C, Harrison CN. Resolution of bone marrow fibrosis in a patient receiving JAK1/JAK2 inhibitor treatment with ruxolitinib. Haematologica. 2013 Dec;98(12):1872-6. doi: 10.3324/haematol.2013.095109. Epub 2013 Sep 20.

ReferenceCitation: Mesa RA, Kiladjian JJ, Verstovsek S, Al-Ali HK, Gotlib J, Gisslinger H, Levy R, Siulnik A, Gupta V, Khan M, DiPersio JF, McQuitty M, Catalano JV, Hunter DS, Knoops L, Deininger M, Cervantes F, Miller C, Vannucchi AM, Silver RT, Barbui T, Talpaz M, Barosi G, Winton EF, Mendeson E, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Sun W, Sandor V, Kantarjian HM, Harrison C. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014 Feb;99(2):292-8. doi: 10.3324/haematol.2013.087650. Epub 2013 Aug 2.

ReferenceCitation: Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi: 10.1056/NEJMoa1110556.

title: A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
France


lead_sponsor: Boehringer Ingelheim

summary: The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).

ReferenceCitation: Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.

location_facility: 502.550.40011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01017 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3307A Boehringer Ingelheim Investigational Site

location_facility: 502.550.40012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01018 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82013 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305G Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302C Boehringer Ingelheim Investigational Site

location_facility: 502.550.35903 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35905 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3306A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01016 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35904 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99503 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304J Boehringer Ingelheim Investigational Site

location_facility: 502.550.82003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302B Boehringer Ingelheim Investigational Site

location_facility: 502.550.86009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99507 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301H Boehringer Ingelheim Investigational Site

location_facility: 502.550.01007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302I Boehringer Ingelheim Investigational Site

location_facility: 502.550.82002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35902 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82012 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304D Boehringer Ingelheim Investigational Site

location_facility: 502.550.35908 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305A Boehringer Ingelheim Investigational Site

location_facility: 502.550.86001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99508 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01020 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01014 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07006 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303C Boehringer Ingelheim Investigational Site

location_facility: 502.550.07005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99504 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301E Boehringer Ingelheim Investigational Site

location_facility: 502.550.99501 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01011 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302G Boehringer Ingelheim Investigational Site

location_facility: 502.550.82001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302D Boehringer Ingelheim Investigational Site

location_facility: 502.550.82009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301I Boehringer Ingelheim Investigational Site

location_facility: 502.550.01019 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3306F Boehringer Ingelheim Investigational Site

location_facility: 502.550.40003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01008 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35911 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303D Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302E Boehringer Ingelheim Investigational Site

location_facility: 502.550.40009 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3305I Boehringer Ingelheim Investigational Site

location_facility: 502.550.07003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303F Boehringer Ingelheim Investigational Site

location_facility: 502.550.86010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07002 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3303A Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301J Boehringer Ingelheim Investigational Site

location_facility: 502.550.99502 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01005 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99505 Boehringer Ingelheim Investigational Site

location_facility: 502.550.86003 Boehringer Ingelheim Investigational Site

location_facility: 502.550.40001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82004 Boehringer Ingelheim Investigational Site

location_facility: 502.550.99506 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304F Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301K Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301F Boehringer Ingelheim Investigational Site

location_facility: 502.550.40010 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3301A Boehringer Ingelheim Investigational Site

location_facility: 502.550.07001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35906 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35910 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35909 Boehringer Ingelheim Investigational Site

location_facility: 502.550.3304A Boehringer Ingelheim Investigational Site

location_facility: 502.550.3302A Boehringer Ingelheim Investigational Site

location_facility: 502.550.01001 Boehringer Ingelheim Investigational Site

location_facility: 502.550.35901 Boehringer Ingelheim Investigational Site

location_facility: 502.550.07007 Boehringer Ingelheim Investigational Site

location_facility: 502.550.01015 Boehringer Ingelheim Investigational Site

location_facility: 502.550.82011 Boehringer Ingelheim Investigational Site

title: A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

type: EudraCT Number

source: euctr

location_country:
Romania
United States
China
Korea, Republic of
Bulgaria
Georgia
Russian Federation
France


summary: A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

location_facility: 1218.52.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2163B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91018 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37201 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91012 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37202 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31015 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38501 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38505 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9991 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2162A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91019 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52009 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2161B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91015 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38504 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3306C Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91013 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.52010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9992 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91014 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91016 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.37203 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2163A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9993 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38503 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.52.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2161A Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.2162B Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38004 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.52.38502 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.40005 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.9999 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.52.3308D Boehringer Ingelheim Investigational Site

title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

location_country:
Germany
Lithuania
India
Romania
Sweden
Netherlands
Mexico
Tunisia
Croatia
Ukraine
Canada
Estonia
Russian Federation
France


title: A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

summary:
Primary objective:

Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

Compare the following parameters following 4 cycles of VD or VTD induction treatment:

CR rate+ very good partial remission (VGPR) rate
Overall remission rate (CR + VGPR + partial remission (PR) rate)
K/l light chain ratio in patients in CR.
Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).

status: Unknown status

ReferenceCitation: Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pegourie B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traulle C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.

lead_sponsor: Intergroupe Francophone du Myelome

location_country: Belgium France

location_facility:
Chu Angers
Ch Dunkerque
Paris Hôtel Dieu
St ETIENNE
CHR Metz Bonsecours
GILLY
Rouen Becquerel
Chu Nancy
CH BLOIS
Paris Cochin
Paris Necker
YVOIR MontGodinne
CHU Tours
Chu Bordeaux
CHU Nice M Interne
Lyon Léon Berard
Chu Nantes
Bruxelles I Bordet
CHR Orléans
Clamart Percy
Paris St Louis
CH St Brieuc
Ch Avignon
Chu Brest
Bruxelles Erasme
CH Chartres
Chu Dijon
Ch Lorient
Marseille IPC
CHU Rennes M interne
CH Annecy
CHRU Strasbourg
BRUXELLES St LUC
ANVERS Centrumziekenhuis
Chu Toulouse
CHU Reims
Caen M Interne Baclèse
Nantes Catherine De Sienne
Bobigny Avicenne
CH Roanne
CH La Roche Sur Yon
Anvers Uza
Chu Besancon
CHU Clermont Ferrand
Chru Lille
Le Mans Victor Hugo
CHU Lyon Edouard Herriot
Chu Grenoble
CHU Poitiers hemato
CHU Lyon Sud Pierre Benite
CH Valence
CHU Rennes Hemato
CH Vannes
Ch Colmar
CH Bayonne
Paris St Antoine

status_simplified: Unknown


title: ARI103094-Follow-Up Study for REDUCE Study Subjects

summary:
ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B:

REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study. Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as follows: (1) REDUCE subjects who completed treatment with investigational product (dutasteride or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit 10). The objective of this observational study for eligible REDUCE subjects is to collect and summarize data on prostate cancer (the incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled study, REDUCE.
REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE study.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Grubb RL, Andriole GL, Somerville MC, Mahoney C, Manyak MJ, Castro R. The REDUCE Follow-Up Study: low rate of new prostate cancer diagnoses observed during a 2-year, observational, followup study of men who participated in the REDUCE trial. J Urol. 2013 Mar;189(3):871-7. doi: 10.1016/j.juro.2012.09.099. Epub 2012 Sep 25.

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.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
United Kingdom
Argentina
Sweden
Netherlands
United States
Spain
Greece
Chile
Canada
France


title: An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.

summary: This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was > 500 individuals.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Poland
Portugal
Hungary
United Kingdom
Romania
Australia
Netherlands
Saudi Arabia
Spain
Greece
Canada
Czech Republic
France


title: Epidemiological Study of European Cardiovascular Risk Patients: Disease Prevention and Management in Usual Daily Practice

acronym: EURIKA

summary:
The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.

The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office.

Study variables will be measured:

By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication.
By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment.
By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured.
CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceCitation: Halcox JP, Banegas JR, Roy C, Dallongeville J, De Backer G, Guallar E, Perk J, Hajage D, Henriksson KM, Borghi C. Prevalence and treatment of atherogenic dyslipidemia in the primary prevention of cardiovascular disease in Europe: EURIKA, a cross-sectional observational study. BMC Cardiovasc Disord. 2017 Jun 17;17(1):160. doi: 10.1186/s12872-017-0591-5.

endpoint_id: fhisxppmrqpajgzqkvft

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

repository_institution: Swansea University - Cronfa

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repository_institution: Uppsala University - Uppsala University Publications

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

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

repository_normalized: dnet

ReferenceCitation: Borghi C, Rodriguez-Artalejo F, De Backer G, Dallongeville J, Medina J, Guallar E, Perk J, Banegas JR, Tubach F, Roy C, Halcox JP. The association between blood pressure and lipid levels in Europe: European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice. J Hypertens. 2016 Nov;34(11):2155-63. doi: 10.1097/HJH.0000000000001078.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Borghi C, Tubach F, De Backer G, Dallongeville J, Guallar E, Medina J, Perk J, Roy C, Banegas JR, Rodriguez-Artalejo F, Halcox JP. Lack of control of hypertension in primary cardiovascular disease prevention in Europe: Results from the EURIKA study. Int J Cardiol. 2016 Sep 1;218:83-88. doi: 10.1016/j.ijcard.2016.05.044. Epub 2016 May 13.

ReferenceCitation: Halcox JP, Tubach F, Lopez-Garcia E, De Backer G, Borghi C, Dallongeville J, Guallar E, Medina J, Perk J, Sazova O, Sweet S, Roy C, Banegas JR, Rodriguez-Artalejo F. Low rates of both lipid-lowering therapy use and achievement of low-density lipoprotein cholesterol targets in individuals at high-risk for cardiovascular disease across Europe. PLoS One. 2015 Feb 18;10(2):e0115270. doi: 10.1371/journal.pone.0115270. eCollection 2015.

ReferenceCitation: Halcox JP, Roy C, Tubach F, Banegas JR, Dallongeville J, De Backer G, Guallar E, Sazova O, Medina J, Perk J, Steg PG, Rodriguez-Artalejo F, Borghi C. C-reactive protein levels in patients at cardiovascular risk: EURIKA study. BMC Cardiovasc Disord. 2014 Feb 24;14:25. doi: 10.1186/1471-2261-14-25.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - INERIS

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

ReferenceCitation: Halcox JP, Tubach F, Sazova O, Sweet S, Medina J; EURIKA steering committee. Reclassification of European patients' cardiovascular risk using the updated Systematic Coronary Risk Evaluation algorithm. Eur J Prev Cardiol. 2015 Feb;22(2):200-2. doi: 10.1177/2047487313507680. Epub 2013 Oct 3.

ReferenceCitation: Schmieder RE, Goebel M, Bramlage P. Barriers to cardiovascular risk prevention and management in Germany--an analysis of the EURIKA study. Vasc Health Risk Manag. 2012;8:177-86. doi: 10.2147/VHRM.S29915. Epub 2012 Mar 15.

ReferenceCitation: Dallongeville J, Banegas JR, Tubach F, Guallar E, Borghi C, De Backer G, Halcox JP, Masso-Gonzalez EL, Perk J, Sazova O, Steg PG, Artalejo FR; EURIKA Investigators. Survey of physicians' practices in the control of cardiovascular risk factors: the EURIKA study. Eur J Prev Cardiol. 2012 Jun;19(3):541-50. doi: 10.1177/1741826711407705. Epub 2011 Apr 18.

ReferenceCitation: Rodriguez-Artalejo F, Guallar E, Borghi C, Dallongeville J, De Backer G, Halcox JP, Hernandez-Vecino R, Jimenez FJ, Masso-Gonzalez EL, Perk J, Steg PG, Banegas JR; EURIKA Investigators. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA). BMC Public Health. 2010 Jun 30;10:382. doi: 10.1186/1471-2458-10-382.

location_country:
Germany
Norway
United Kingdom
Sweden
Switzerland
Austria
Belgium
Spain
Greece
Turkey
Russian Federation
France


acronym: ExteNET

lead_sponsor: Puma Biotechnology, Inc.

summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

ReferenceCitation: Iwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, Chiu J, Ohtani S, Takahashi M, Miyaki T, Lu YS, Xu B, Yap YS, Bustam A, Yao B, Zhang B, Bryce R, Chan A. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer. Future Oncol. 2019 Jul;15(21):2489-2501. doi: 10.2217/fon-2019-0143. Epub 2019 May 29.

oa_host_type: closed

publisher_dissemination: Future Science Ltd

ReferenceCitation: Chia SKL, Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Kim SB, Jakobsen EH, Harvey V, Robert N, Smith J 2nd, Harker G, Zhang B, Eli LD, Ye Y, Lalani AS, Buyse M, Chan A. PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial. Breast Cancer Res. 2019 Mar 11;21(1):39. doi: 10.1186/s13058-019-1115-2.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Mortimer J, Di Palma J, Schmid K, Ye Y, Jahanzeb M. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019 Feb 27;21(1):32. doi: 10.1186/s13058-019-1112-5.

ReferenceCitation: Delaloge S, Cella D, Ye Y, Buyse M, Chan A, Barrios CH, Holmes FA, Mansi J, Iwata H, Ejlertsen B, Moy B, Chia SKL, Gnant M, Smichkoska S, Ciceniene A, Martinez N, Filipovic S, Ben-Baruch NE, Joy AA, Langkjer ST, Senecal F, de Boer RH, Moran S, Yao B, Bryce R, Auerbach A, Fallowfield L, Martin M. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol. 2019 Apr 1;30(4):567-574. doi: 10.1093/annonc/mdz016.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13.

ReferenceCitation: Chan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SKL, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J 2nd, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-377. doi: 10.1016/S1470-2045(15)00551-3. Epub 2016 Feb 10.

location_facility: AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Massachusetts General Hospital - Gillette Center

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Ospedale Treviglio e Caravaggio, UO Oncologia Medica

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: Centrum Onkologii im. prof. Franciszka Łukaszczyka

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"

location_facility: Washington Cancer Institute at Washington Hospital Center

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

location_facility: Oncology-Hematology of Lehigh Valley, PC

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Interdistrict Dispensary for Oncology Diseases

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Gemeinschaftspraxis fuer Haematologie und Onkologie

location_facility: Kreiskrankenhaus Hameln, Onkologische Ambulanz

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: Hospital Universitario Fundacion de Alcorcon

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD

location_facility: Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella

location_facility: Mid-Florida Hematology & Oncology Centers, PA

location_facility: Seoul National University Hospital, Department of Internal Medicine

location_facility: Presidio Ospedaliero di Summa - Antonio Perrino

location_facility: Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku

location_facility: Oncologia Medica A, Istituti Fisioterapici Ospitalieri

location_facility: Kaposi Mor Oktato Korhaz, Onkologiai Centrum

location_facility: Raleigh Hematology Oncology Associates Cancer Centers of North Carolina

location_facility: University General Hospital of Alexandroupoli, Department of Medical Oncology

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Augusta Oncology Associates (ACORN), P.C.

location_facility: Rambam Health care campus, Oncology institute

location_facility: The Hospital of Lithuanian University of Health Sciences Kauno klinikos Oncology and Haematology Clinic

location_facility: University Hematology/Oncology Associates PLLC

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Dwight David Eisenhower Army Medical Center

location_facility: Center for Integrative Cancer Medicine, PA

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt.

location_facility: Harry and Jeanette Weinberg Cancer Center

location_facility: Uniwersyteckie Centrum Kliniczne w Gdansku

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Samaritan Hematology & Oncology Consultants

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki

location_facility: Institut Onkologie a Reahabilitace na Plesi

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: Avera Medical Oncology and Hematology - Avera Cancer Institute

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Queen Mary Hospital, Department of Medicine, Blk K

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: University Clinic for Radiotherapy and Oncology

location_facility: Clinique Sainte Anne Centre de Radiothérapie

location_facility: Oncology Institute of Vilnius University

location_facility: University Hospitals, Cleveland Medical Center

location_facility: Soroka University MC, Department of Oncology

location_facility: Stronach Regional Cancer Centre at Southlake

location_facility: University of Texas Southwestern Medical Center Simmons Cancer Center

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli"

location_facility: Desert Hematology Oncology Medical Group, Inc

location_facility: Oncologie department, Hopital albert Michalon

location_facility: East Texas Medical Center Cancer Institute

location_facility: Pinnacle Health Cancer Center Community Campus

location_facility: Semmelweis Egyetem Radiologiai és Onkoterapias Klinika

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w

location_facility: Southeast Nebraska Hematology & Oncology Consultants, PC

location_facility: Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Duke University Medical Center Medical Oncology

location_facility: Abington Hematology Oncology Associates, Inc

location_facility: Quincy Medical Group, Cancer Center at Blessing Hospital

location_facility: Facharzt fuer Frauenheilkunde und Geburtshilfe

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Administradora Country S.A-Clinica del Country

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Humber River Regional Hospital - Church Street Site

location_facility: NorthEast Oncology Associates Carolinas Medical Center NorthEast

location_facility: Southern Medical University Nanfang Hospital

location_facility: Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie

location_facility: Korea University Anam Hospital, Department of Oncology/Hematology

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w

location_facility: Jabboury Foundation for Cancer Research, Inc.

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: McLeod Oncology and Hematology Associates

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.

location_facility: Charing Cross Hospital, Department Of Medical Oncology

location_facility: Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist

location_facility: Helen Diller Family University of California San Francisco Comprehensive Cancer Center

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Southwestern Vermont Regional Cancer Center

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Birmingham Hematology and Oncology Associates, LLC

location_facility: Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research

location_facility: The Cancer Prevention and Treatment Center

location_facility: ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa

location_facility: Queen Mary Hospital, Department of Medicine

location_facility: University Hospital Centre Osijek, Department of Radiotherapy and Oncology

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

location_facility: Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Medicus Alliance Clinical Research Org., Inc.

location_facility: Klinik für Gynaekologie und gyn. Onkologie

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Glendale Adventist Medical Center Cancer Services

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Alliance Hematology Oncology, PA Carroll County Cancer Center

location_facility: Providence Cancer Center Oncology and Hematology Care - Westside

location_facility: North Adelaide Oncology Calvary Hospital North Adelaide

location_facility: IRCCS Istituto Oncologico Veneto di Padova

location_facility: Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Specialised Hospital of Active Treatment in Oncology

location_facility: Medical Oncology & Hematology Mercy Medical Center

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Kurume Daiichi Social Insurance Hospital

location_facility: VZW Jesseziekenhuis - Campus Virga Jesse

location_facility: Nationales Centrum fuer Tumorerkrankungen

location_facility: Sheba Medical Center, Oncology Institute Tel Hashomer

location_facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

location_facility: The Center for Cancer and Hematologic Disease

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: Klinikum St. Georg/Franziskus, Abteilung fuer Senologie

location_facility: Centre Hospitalier Regional de La Citadelle

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second

location_facility: Wheaton Franciscan Cancer Care-All Saints

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Praxis für interdisziplinaere Onkologie & Haematologie GbR

location_facility: Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Kaplan Medical Center, Department of Oncology

location_facility: Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Frauenklinik der J.W. Goethe-Universitaet

location_facility: Sozialstiftung Bamberg Klinik fuer Haematologie und Internistische Onkologie

location_facility: Institut Curie, Département d'Oncologie Médicale

location_facility: Kaohsiung Medical University Chung-Ho memorial Hospital

location_facility: Klinicki bolnicki centar "Sestre Milosrdnice"

location_facility: Queen Mary Hospital, Department of Clinical Oncology, Professorial Block

location_facility: ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta

location_facility: Mercy Hospital Oncology/Hematology Center

location_facility: Clínica Vista Alegre / Unidad de Investigacion

title: A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

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acronym: Sprint

lead_sponsor: Celgene

summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

ReferenceCitation: Trneny M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trumper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-331. doi: 10.1016/S1470-2045(15)00559-8. Epub 2016 Feb 16.

ReferenceCitation: Hagner PR, Chiu H, Ortiz M, Apollonio B, Wang M, Couto S, Waldman MF, Flynt E, Ramsay AG, Trotter M, Gandhi AK, Chopra R, Thakurta A. Activity of lenalidomide in mantle cell lymphoma can be explained by NK cell-mediated cytotoxicity. Br J Haematol. 2017 Nov;179(3):399-409. doi: 10.1111/bjh.14866. Epub 2017 Aug 2.

evidence: open (via free article)

repository_institution: King's College London - Research Portal

publisher_dissemination: Wiley

location_facility: Rigshospitalet Department of Haematology L4042

location_facility: University Hospital2.Dep. of Int.med. hematology

location_facility: Centre Hospitalier Departemental Les Oudrairies

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Saratov Medical University Chair of Professional Pathology and Haematology

location_facility: Teaching Hospital BrnoHemato-oncology Dept

location_facility: Uniwersytet Jagiellonski Collegium Medicum

location_facility: Attikon General University Hospital of Athens

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych

location_facility: Scientific Research Institute of OncologySoft Tissue Department

location_facility: Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie

location_facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie

location_facility: Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko

location_facility: Volgograd Regional Clinical Oncology Dispensary 1

location_facility: Novosibirsk State Regional Clinical Hospital

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

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

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: St. Petersburg Pavlov State Medical University

title: A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Sweden
Netherlands
Belgium
Spain
Greece
Czechia
Russian Federation
France


summary: This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.

ReferenceCitation: Vergote I, du Bois A, Floquet A, Rau J, Kim JW, Del Campo JM, Friedlander M, Pignata S, Fujiwara K, Colombo N, Mirza MR, Monk BJ, Tsibulak I, Calvert PM, Herzog TJ, Hanker LC, Meunier J, Lee JY, Bologna A, Carrasco-Alfonso MJ, Harter P. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol. 2019 Nov;155(2):186-191. doi: 10.1016/j.ygyno.2019.08.024. Epub 2019 Sep 10.

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: INFN Catania - INFM-OAR

repositories:
LIRIAS (KU Leuven)
Zenodo
boa.unimib.it

repositories_concat: LIRIAS (KU Leuven);Zenodo;boa.unimib.it

ReferenceCitation: Friedlander M, Rau J, Lee CK, Meier W, Lesoin A, Kim JW, Poveda A, Buck M, Scambia G, Shimada M, Hilpert F, King MT, Debruyne P, Bologna A, Malander S, Monk BJ, Petru E, Calvert P, Herzog TJ, Barrett C, du Bois A. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol. 2018 Mar 1;29(3):737-743. doi: 10.1093/annonc/mdx796.

ReferenceCitation: Pulford DJ, Harter P, Floquet A, Barrett C, Suh DH, Friedlander M, Arranz JA, Hasegawa K, Tada H, Vuylsteke P, Mirza MR, Donadello N, Scambia G, Johnson T, Cox C, Chan JK, Imhof M, Herzog TJ, Calvert P, Wimberger P, Berton-Rigaud D, Lim MC, Elser G, Xu CF, du Bois A. Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Med Ethics. 2016 Oct 21;17(1):63. doi: 10.1186/s12910-016-0144-y.

repository_institution: PubMed Central - Europe PMC

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repositories:
PubMed Central
dnet
www.lenus.ie

repositories_concat: PubMed Central;dnet;www.lenus.ie

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

ReferenceCitation: Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.

publisher_dissemination: British Medical Journal

ReferenceCitation: Floquet A, Vergote I, Colombo N, Fiane B, Monk BJ, Reinthaller A, Calvert P, Herzog TJ, Meier W, Kim JW, del Campo JM, Friedlander M, Pisano C, Isonishi S, Crescenzo RJ, Barrett C, Wang K, Mitrica I, du Bois A. Progression-free survival by local investigator versus independent central review: comparative analysis of the AGO-OVAR16 Trial. Gynecol Oncol. 2015 Jan;136(1):37-42. doi: 10.1016/j.ygyno.2014.11.074. Epub 2014 Nov 28.

ReferenceCitation: du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. doi: 10.1200/JCO.2014.55.7348. Epub 2014 Sep 15.

title: A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

type: Other Identifier

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

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

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ipd_sharing: Undecided