title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

summary: The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

primary_purpose: Prevention

ReferenceCitation: Ruiz-Palacios GM, Leroux-Roels G, Beran J, Devaster JM, Esen M, Launay O, McElhaney JE, van Essen GA, Benoit A, Claeys C, Dewé W, Durand C, Duval X, Falsey AR, Feldman G, Galtier F, Gervais P, Hwang SJ, McNeil S, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis. Hum Vaccin Immunother. 2016 Dec;12(12):3043-3055. doi: 10.1080/21645515.2016.1219809.

name: Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, C.P. México City, México

family: Ruiz-Palacios

full_name: Guillermo M. Ruiz-Palacios

given: Guillermo M.

name: Centre for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium

family: Leroux-Roels

full_name: Geert Leroux-Roels

given: Geert

name: Vaccination and Travel Medicine Centre, Hradec Kralove, Czech Republic; and 2nd Faculty of Medicine, Charles University in Prague, Czech Republic

family: Beran

full_name: Jiri Beran

given: Jiri

name: Jeanne-Marie Devaster, MD, GSK Vaccines, Rixensart, Belgium

family: Devaster

full_name: Jeanne-Marie Devaster

given: Jeanne-Marie

name: Institut für Tropenmedizin, Tübingen, Germany

family: Esen

full_name: Meral Esen

given: Meral

name: Inserm, CIC 1417 and French Network of Clinical Investigation in Vaccinology (I-REIVAC), France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Cochin, CIC Cochin Pasteur, Paris, France

family: Launay

full_name: Odile Launay

given: Odile

name: HSN Volunteer Association Chair in Geriatric Research, Health Sciences North Research Institute, Sudbury, ON, Canada

family: McElhaney

full_name: Janet E. McElhaney

given: Janet E.

name: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands

family: van Essen

full_name: Gerrit A. van Essen

given: Gerrit A.

name: Institute of Statistics, Biostatistics and Actuarial Sciences, Université Catholique de Louvain, Louvain-la-Neuve, Belgium

family: Benoit

full_name: Anne Benoit

given: Anne

family: Claeys

full_name: Carine Claeys

given: Carine

family: Dewé

full_name: Walthère Dewé

given: Walthère

family: Durand

full_name: Christelle Durand

given: Christelle

name: Hôpital Bichat Claude Bernard, GH BICHAT. Paris cedex 18, France; Inserm, CIC 007 for the French Network of Clinical Investigation in Vaccinology (REIVAC), Paris Cedex 18, France

family: Duval

full_name: Xavier Duval

given: Xavier

name: University of Rochester Medical Center, Rochester General Hospital, Rochester, NY, USA

family: Falsey

full_name: Ann R. Falsey

given: Ann R.

name: Carolina Pharmaceutical Research, Spartanburg, South Carolina, United States

family: Feldman

full_name: Gregory Feldman

given: Gregory

name: CHRU de Montpellier, Hôpital Saint Eloi, Montpellier, France; Inserm, CIC 1001 for the French Network of Clinical Investigation in Vaccinology (REIVAC), Montpellier, France

family: Galtier

full_name: Florence Galtier

given: Florence

name: Q&T Research Sherbrooke, Sherbrooke, QC, Canada

family: Gervais

full_name: Pierre Gervais

given: Pierre

name: Department of Family Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; National Yang-Ming University School of Medicine, Taipei, Taiwan

family: Hwang

full_name: Shinn-Jang Hwang

given: Shinn-Jang

name: Queen Elizabeth Health Sciences Centre, Dalhousie University, PCIRN, NACI, CCfV, CAIRE, QEII HSC - VG Site Infectious Diseases, Halifax, Nova Scotia, Canada

family: McNeil

full_name: Shelly McNeil

given: Shelly

name: GGD Rotterdam-Rijnmond, Rotterdam, The Netherlands

family: Richardus

full_name: Jan Hendrik Richardus

given: Jan Hendrik

family: Trofa

full_name: Andrew Trofa

given: Andrew

family: Oostvogels

full_name: Lidia Oostvogels

given: Lidia

repository_institution: Ghent University - Ghent University Academic Bibliography

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

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

ReferenceCitation: van Essen GA, Beran J, Devaster JM, Durand C, Duval X, Esen M, Falsey AR, Feldman G, Gervais P, Innis BL, Kovac M, Launay O, Leroux-Roels G, McElhaney JE, McNeil S, Oujaa M, Richardus JH, Ruiz-Palacios G, Osborne RH, Oostvogels L. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines. Influenza Other Respir Viruses. 2014 Jul;8(4):452-62. doi: 10.1111/irv.12245. Epub 2014 Apr 4.

name: Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht The Netherlands

name: Vaccination and Travel Medicine Centre Poliklinika 2 Czech Republic

name: Inserm CIC 007 U 738 Hôpital Bichat Claude Bernard Paris France

name: Institut für Tropenmedizin Tübingen Germany

name: University of Rochester Medical Center Rochester NY USA

name: S. Carolina Pharmaceutical Research Spartanburg SC USA

name: Q&T Research Sherbrooke Sherbrooke QC Canada

name: GlaxoSmithKline Vaccines King of Prussia PA USA

name: Inserm CIC BT505, and National Network of Clinical Investigation in Vaccinology (REIVAC) Paris France

name: Assistance Publique Hôpitaux de Paris Groupe Hospitalier Paris Centre ‐ CIC de Vaccinologie Cochin/Pasteur Paris France

name: Centre for Vaccinology Ghent University and Hospital Ghent Belgium

name: HSN Volunteer Association Chair in Geriatric Research Advanced Medical Research Institute of Canada Sudbury ON Canada

name: Queen Elizabeth Health Sciences Centre Dalhousie University PCIRN NACI CCfV CAIRE QEII HSC ‐ VG Site Infectious Diseases Halifax NS Canada

name: GGD Rotterdam‐Rijnmond Rotterdam The Netherlands

name: Department of Infectious Diseases Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán México City México

name: Public Health Innovation Population Health Strategic Research Centre Deakin University Melbourne Australia

name: Measured Solutions for Health (MESH) P/L Melbourne Australia

repository_institution: Deakin University - Deakin Research Online

title: Influenza symptoms and their impact on elderly adults: randomised trial of AS 03‐adjuvanted or non‐adjuvanted inactivated trivalent seasonal influenza vaccines

ReferenceCitation: McElhaney JE, Beran J, Devaster JM, Esen M, Launay O, Leroux-Roels G, Ruiz-Palacios GM, van Essen GA, Caplanusi A, Claeys C, Durand C, Duval X, El Idrissi M, Falsey AR, Feldman G, Frey SE, Galtier F, Hwang SJ, Innis BL, Kovac M, Kremsner P, McNeil S, Nowakowski A, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013 Jun;13(6):485-96. doi: 10.1016/S1473-3099(13)70046-X. Epub 2013 Mar 19.

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:
United States
Mexico
Netherlands
Germany
France
Czechia
Poland
Norway
Romania
Belgium
Russian Federation
Estonia
Canada
United Kingdom
Taiwan


title: International Multi-Center Open Label Study 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 or Anti-TNF Therapy.

summary: This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country:
Luxembourg
Finland
Greece
Romania
Australia
Belgium
Denmark
Czech Republic
India
France
Poland
Canada
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Spain
Turkey

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

summary: The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

ReferenceType: derived

ReferenceCitation: Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.

name: Metrum Research Group LLC; Tariffville; CT; USA

family: Riggs

full_name: Matthew M. Riggs

given: Matthew M.

sequence: first

name: Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach; Germany

family: Staab

full_name: Alexander Staab

given: Alexander

sequence: additional

name: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield; CT; USA

family: Seman

full_name: Leo Seman

given: Leo

family: MacGregor

full_name: Thomas R. MacGregor

given: Thomas R.

family: Bergsma

full_name: Timothy T. Bergsma

given: Timothy T.

family: Gastonguay

full_name: Marc R. Gastonguay

given: Marc R.

family: Macha

full_name: Sreeraj Macha

given: Sreeraj

bso_classification: Chemistry

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Boehringer Ingelheim

location_country:
Austria
Spain
Germany
Finland
France
Slovakia
Norway
Hungary
Argentina
Latvia
Romania
Russian Federation
Estonia
United States
Czech Republic
Ukraine

location_facility: 1245.10.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3308A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37202 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34008 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3307A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34010 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37105 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40007 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37104 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70007 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37107 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37101 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37103 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37106 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3301B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37102 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37201 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3308B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54008 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3306B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10010 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10027 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3302B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10028 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49004 Boehringer Ingelheim Investigational Site


title: Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.

summary:
The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

design_allocation: Randomized

ReferenceCitation: Flourié B, Hagège H, Tucat G, Maetz D, Hébuterne X, Kuyvenhoven JP, Tan TG, Pierik MJ, Masclee AA, Dewit O, Probert CS, Aoucheta D; MOTUS study investigators. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis. Aliment Pharmacol Ther. 2013 Apr;37(8):767-75. doi: 10.1111/apt.12266. Epub 2013 Mar 4.

name: Department of Gastroenterology; Lyon Sud Hospital; Pierre Benite; France

family: Flourié

full_name: B. Flourié

given: B.

name: ANGH (Association Nationale des Gastroentérologues des Hôpitaux); Department of Hépato-gastroentérologie; Centre Hospitalier Intercommunal Créteil; Créteil Cedex; France

family: Hagège

full_name: H. Hagège

given: H.

name: CREGG (Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie); France

family: Tucat

full_name: G. Tucat

given: G.

name: Hazebrouck Medical Centre; Hazebrouck; France

family: Maetz

full_name: D. Maetz

given: D.

name: Department of Gastroenterology and Nutrition; CHU of Nice and IRCAN Inserm U1081 Team 3; University of Nice Sophia-Antipolis; Nice; France

family: Hébuterne

full_name: X. Hébuterne

given: X.

name: Department of Gastroenterology-Hepatology; Kennemer Gasthuis; Haarlem; The Netherlands

family: Kuyvenhoven

full_name: J. P. Kuyvenhoven

given: J. P.

name: Department of Gastroenterology; Medisch Centrum de Veluwe; Apeldoorn; The Netherlands

family: Tan

full_name: T. G. Tan

given: T. G.

name: Division of Gastroenterology-Hepatology; Maastricht University Medical Center; Maastricht; The Netherlands

family: Pierik

full_name: M. J. Pierik

given: M. J.

family: Masclee

full_name: A. A. M. Masclee

given: A. A. M.

name: Department of Gastroenterology; UCL Saint Luc; Brussels; Belgium

family: Dewit

full_name: O. Dewit

given: O.

name: Department of Gastroenterology; Institute of Translational Medicine; University of Liverpool; Liverpool; UK

family: Probert

full_name: C. S. Probert

given: C. S.

family: Aoucheta

full_name: D. Aoucheta

bso_classification: Medical research

journal_name: Alimentary Pharmacology & Therapeutics

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

lead_sponsor: Ferring Pharmaceuticals

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility: Investigational site - 91 rue Caulaincourt

location_facility: Centre Hospitalier Universitaire Albert MICHALON

location_facility: Clinique Saint Martin - 18 rue Rocquemonts

location_facility: Clinique Saint Jean Languedoc - 20 route de Revel

location_facility: Investigational site - 186 avenue de la Rose

location_facility: Investigational site - 127 boulevard St Germain

location_facility: IJsselmeer Ziekenhuis Loc. Lelystad, Poli MDL

location_facility: Investigational site - 23 bis, place Sébastol


ReferenceCitation: Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.

family: Ratjen

full_name: Felix Ratjen

given: Felix

family: Koker

full_name: Paul Koker

given: Paul

family: Geller

full_name: David E. Geller

given: David E.

family: Langellier-Cocteaux

full_name: Berengere Langellier-Cocteaux

given: Berengere

family: Le Maulf

full_name: Florence Le Maulf

given: Florence

family: Kattenbeck

full_name: Sabine Kattenbeck

given: Sabine

family: Moroni-Zentgraf

full_name: Petra Moroni-Zentgraf

given: Petra

family: Elborn

full_name: J. Stuart Elborn

given: J. Stuart

journal_name: Journal of Cystic Fibrosis

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

host_type: repository

repository_institution: Queen's University Belfast - Research Portal

repositories_institution: Queen's University Belfast - Research Portal

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Tiotropium Respimat® in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials

ReferenceCitation: Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat® in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.

family: Bradley

full_name: Judy M. Bradley

given: Judy M.

family: Deng

full_name: Qiqi Deng

given: Qiqi

name: on behalf of the Tiotropium Cystic Fibrosis Study Group

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

title: Testing Two Different Doses of Tiotropium Respimat® in Cystic Fibrosis: Phase 2 Randomized Trial Results

location_country:
Italy
Netherlands
Germany
France
Belgium
Australia
New Zealand
Portugal
Russian Federation
United States
United Kingdom

location_facility: 205.339.032 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44184 Boehringer Ingelheim Investigational Site

location_facility: 205.339.024 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3302B Boehringer Ingelheim Investigational Site

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title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

summary: This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations


type: Other Identifier

title: A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics

acronym: PALMFlexS

summary: This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.

ReferenceCitation: Schreiner A, Bergmans P, Cherubin P, Keim S, Rancans E, Bez Y, Parellada E, Carpiniello B, Vidailhet P, Hargarter L. A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clin Ther. 2014 Oct 1;36(10):1372-88.e1. doi: 10.1016/j.clinthera.2014.08.014. Epub 2014 Oct 23. Erratum in: Clin Ther. 2014 Nov 1;36(11):1705.

family: Schreiner

full_name: Andreas Schreiner

given: Andreas

family: Bergmans

full_name: Paul Bergmans

family: Cherubin

full_name: Pierre Cherubin

given: Pierre

family: Keim

full_name: Sofia Keim

given: Sofia

family: Rancans

full_name: Elmars Rancans

given: Elmars

family: Bez

full_name: Yasin Bez

given: Yasin

family: Parellada

full_name: Eduard Parellada

given: Eduard

family: Carpiniello

full_name: Bernardo Carpiniello

given: Bernardo

family: Vidailhet

full_name: Pierre Vidailhet

family: Hargarter

full_name: Ludger Hargarter

given: Ludger

journal_name: Clinical Therapeutics

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

version: submittedVersion

title: A Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents

lead_sponsor: Janssen-Cilag International NV

location_country:
Austria
Sweden
Switzerland
Netherlands
Spain
United Kingdom
Croatia
France
Greece
Israel
Lithuania
Hungary
Belgium
Portugal
Estonia
Denmark
Germany
Latvia
Turkey
Ukraine


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)

summary: This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

study_start_date_type: Actual

status: Terminated

ReferenceCitation: Scagliotti G, von Pawel J, Novello S, Ramlau R, Favaretto A, Barlesi F, Akerley W, Orlov S, Santoro A, Spigel D, Hirsh V, Shepherd FA, Sequist LV, Sandler A, Ross JS, Wang Q, von Roemeling R, Shuster D, Schwartz B. Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Aug 20;33(24):2667-74. doi: 10.1200/JCO.2014.60.7317. Epub 2015 Jul 13.

name: Giorgio Scagliotti and Silvia Novello, University of Turin, Orbassano, Torino; Adolfo Favaretto, Istituto Oncologico Veneto, Padova; Armando Santoro, Istituto Clinico Humanitas, Milan, Italy; Joachim von Pawel, Asklepios-Fachkliniken München-Gauting, Munich, Germany; Rodryg Ramlau, Poznań University of Medical Sciences, Poznań, Poland; Fabrice Barlesi, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France; Wallace Akerley, Huntsman Cancer Institute, Salt Lake City, UT;...

family: Scagliotti

full_name: Giorgio Scagliotti

given: Giorgio

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

family: Novello

full_name: Silvia Novello

given: Silvia

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Favaretto

full_name: Adolfo Favaretto

given: Adolfo

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Akerley

full_name: Wallace Akerley

given: Wallace

family: Orlov

full_name: Sergey Orlov

given: Sergey

family: Santoro

full_name: Armando Santoro

given: Armando

family: Spigel

full_name: David Spigel

given: David

family: Hirsh

full_name: Vera Hirsh

given: Vera

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

family: Sequist

full_name: Lecia V. Sequist

given: Lecia V.

family: Sandler

full_name: Alan Sandler

given: Alan

family: Ross

full_name: Jeffrey S. Ross

given: Jeffrey S.

family: Wang

full_name: Qiang Wang

given: Qiang

family: von Roemeling

full_name: Reinhard von Roemeling

given: Reinhard

family: Shuster

full_name: Dale Shuster

given: Dale

family: Schwartz

full_name: Brian Schwartz

given: Brian

journal_name: Journal of Clinical Oncology

oa_host_type: repository

repository_institution: University of Turin - Institutional Research Information System University of Turin

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non–Small-Cell Lung Cancer

ReferenceCitation: Scagliotti GV, Novello S, Schiller JH, Hirsh V, Sequist LV, Soria JC, von Pawel J, Schwartz B, Von Roemeling R, Sandler AB. Rationale and design of MARQUEE: a phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):391-5. doi: 10.1016/j.cllc.2012.01.003. Epub 2012 Mar 21.

full_name: Giorgio V. Scagliotti

given: Giorgio V.

title: Rationale and Design of MARQUEE: A Phase III, Randomized, Double-Blind Study of Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Patients With Locally Advanced or Metastatic, Nonsquamous, Non–Small-Cell Lung Cancer

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Argentina
Canada
Chile
Sweden
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain


title: Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine

acronym: ONTIME

summary: The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.

ReferenceType: background

ReferenceCitation: Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.

ReferenceCitation: Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.

ReferenceType: result

ReferenceCitation: Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Al-Kali

full_name: Aref Al-Kali

given: Aref

family: Baer

full_name: Maria R Baer

given: Maria R

family: Sekeres

full_name: Mikkael A Sekeres

given: Mikkael A

family: Roboz

full_name: Gail J Roboz

given: Gail J

family: Gaidano

full_name: Gianluca Gaidano

given: Gianluca

family: Scott

full_name: Bart L Scott

given: Bart L

family: Greenberg

full_name: Peter Greenberg

given: Peter

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

family: Steensma

full_name: David P Steensma

given: David P

family: Kambhampati

full_name: Suman Kambhampati

given: Suman

family: Kreuzer

full_name: Karl-Anton Kreuzer

given: Karl-Anton

family: Godley

full_name: Lucy A Godley

given: Lucy A

family: Atallah

full_name: Ehab Atallah

given: Ehab

family: Collins

full_name: Robert Collins

given: Robert

suffix: Jr

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: Jabbour

full_name: Elias Jabbour

given: Elias

family: Wilhelm

full_name: Francois E Wilhelm

given: Francois E

family: Azarnia

full_name: Nozar Azarnia

given: Nozar

family: Silverman

full_name: Lewis R Silverman

given: Lewis R

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review.

ReferenceCitation: Al-Kali A. Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (HMA). Journal of Clinical Oncology 2017 35:15_suppl, 7056-7056 ASCO 2017

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

location_country:
Italy
United States
France
Belgium
Spain
Germany

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University of California San Diego Moores Cancer Center

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Azienda Ospedaliera Universitaria Careggi di Firenze

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: University of Pennsylvania Health System

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

location_facility: Azienda Ospedaliera-Universitairia Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: CHU Perpignan Centre Hospitalier Hôpital Saint-Jean

location_facility: Mount Sinai Comprehensive Cancer Centers

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Oklahoma Health Science Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Azienda Osperdaliera Universitaria Maggiore della Carità

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: CHU Avignon Centre Hospitalier Henri Dufaut

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: CHU Angers Service de Medecine D - Maladies du Sang

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

location_facility: Emory University Winship Cancer Institute

location_facility: University of Texas M. D. Anderson Cancer Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: Hospital Clínico Universitario de Salamanca


ReferenceCitation: Kubicka S, Greil R, André T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Müller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.

family: Kubicka

full_name: S. Kubicka

given: S.

family: Greil

full_name: R. Greil

given: R.

family: André

full_name: T. André

given: T.

family: Bennouna

full_name: J. Bennouna

given: J.

family: Sastre

full_name: J. Sastre

family: Van Cutsem

full_name: E. Van Cutsem

given: E.

family: von Moos

full_name: R. von Moos

family: Österlund

full_name: P. Österlund

given: P.

family: Reyes-Rivera

full_name: I. Reyes-Rivera

given: I.

family: Müller

full_name: T. Müller

family: Makrutzki

full_name: M. Makrutzki

given: M.

family: Arnold

full_name: D. Arnold

given: D.

family: Andel

full_name: J. Andel

family: Balcke

full_name: P. Balcke

family: Benedicic

full_name: B. Benedicic

given: B.

family: Eisterer

full_name: W. Eisterer

given: W.

family: Fridrik

full_name: M. Fridrik

family: Jagdt

full_name: B. Jagdt

family: Keil

full_name: F. Keil

given: F.

family: Kretschmer

full_name: A. Kretschmer

given: A.

family: Krippl

full_name: P. Krippl

family: Oexle

full_name: H. Oexle

given: H.

family: Pecherstorfer

full_name: M. Pecherstorfer

family: Samonigg

full_name: H. Samonigg

family: Schmid

full_name: M. Schmid

ReferenceCitation: Bennouna J, Sastre J, Arnold D, Österlund P, Greil R, Van Cutsem E, von Moos R, Viéitez JM, Bouché O, Borg C, Steffens CC, Alonso-Orduña V, Schlichting C, Reyes-Rivera I, Bendahmane B, André T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.

location_country:
Austria
Sweden
Saudi Arabia
Switzerland
Netherlands
Spain
Finland
France
Norway
Belgium
Portugal
Estonia
Denmark
Germany
Czech Republic

title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

summary: This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.


ReferenceCitation: Steg PG, Mehta SR, Pollack CV Jr, Bode C, Gaudin C, Fanouillere K, Moryusef A, Wiviott SD, Sabatine MS. Design and rationale of the treatment of acute coronary syndromes with otamixaban trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non-ST-segment elevation acute coronary syndromes with a planned early invasive strategy. Am Heart J. 2012 Dec;164(6):817-24.e13. doi: 10.1016/j.ahj.2012.10.001. Epub 2012 Nov 7.

ReferenceCitation: Steg PG, Mehta SR, Pollack CV Jr, Bode C, Cohen M, French WJ, Hoekstra J, Rao SV, Ruzyllo W, Ruiz-Nodar JM, Sabaté M, Widimsky P, Kiss RG, Navarro Estrada JL, Hod H, Kerkar P, Guneri S, Sezer M, Ruda M, Nicolau JC, Cavallini C, Ebrahim I, Petrov I, Kim JH, Jeong MH, Ramos Lopez GA, Laanmets P, Kovar F, Gaudin C, Fanouillere KC, Minini P, Hoffman EB, Moryusef A, Wiviott SD, Sabatine MS; TAO Investigators. Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial. JAMA. 2013 Sep 18;310(11):1145-55. doi: 10.1001/jama.2013.277165.

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

journal_name: JAMA

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Anticoagulation With Otamixaban and Ischemic Events in Non–ST-Segment Elevation Acute Coronary Syndromes

ReferenceCitation: Abtan J, Wiviott SD, Sorbets E, Popovic B, Elbez Y, Mehta SR, Sabatine MS, Bode C, Pollack CV, Cohen M, Moccetti T, Laanmets P, Faxon D, Okreglicki A, Ducrocq G, Steg PG; TAO investigators. Prevalence, clinical determinants and prognostic implications of coronary procedural complications of percutaneous coronary intervention in non-ST-segment elevation myocardial infarction: Insights from the contemporary multinational TAO trial. Arch Cardiovasc Dis. 2021 Mar;114(3):187-196. doi: 10.1016/j.acvd.2020.09.005. Epub 2021 Jan 29.

family: Abtan

full_name: Jeremie Abtan

given: Jeremie

family: Wiviott

full_name: Stephen D. Wiviott

given: Stephen D.

family: Sorbets

full_name: Emmanuel Sorbets

given: Emmanuel

family: Popovic

full_name: Batric Popovic

given: Batric

family: Elbez

full_name: Yedid Elbez

given: Yedid

family: Mehta

full_name: Shamir R. Mehta

given: Shamir R.

family: Sabatine

full_name: Marc S. Sabatine

given: Marc S.

family: Bode

full_name: Christoph Bode

given: Christoph

family: Pollack

full_name: Charles V. Pollack

given: Charles V.

family: Cohen

full_name: Marc Cohen

given: Marc

family: Moccetti

full_name: Tiziano Moccetti

given: Tiziano

family: Laanmets

full_name: Peep Laanmets

given: Peep

family: Faxon

full_name: David Faxon

given: David

family: Okreglicki

full_name: Andrzej Okreglicki

given: Andrzej

family: Ducrocq

full_name: Gregory Ducrocq

given: Gregory

full_name: Ph. Gabriel Steg

given: Ph. Gabriel

journal_name: Archives of Cardiovascular Diseases

ReferenceCitation: Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Petrauskiene B, Henry P, Dorobantu M, French WJ, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial. Circ Cardiovasc Interv. 2021 Jan;14(1):e009759. doi: 10.1161/CIRCINTERVENTIONS.120.009759. Epub 2021 Jan 12.

name: Université de Paris, Hôpital Lariboisière, AP-HP, Inserm U-942, Paris, France (J.-G.D., P.H.).

name: Université de Paris, AP-HP, FACT, FHU APOLLO, Hôpital Bichat, Inserm U-1148, Paris, France (G.D., Y.E., P.G.S.).

name: Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School (M.C.).

name: Medizinische Universitatsklinik, Freiburg, Germany (C.B.).

name: University of Mississippi School of Medicine, Jackson (C.P.).

name: Clinic of Cardiovascular Diseases, Vilnius University, Lithuania (B.P.).

name: Clinical Emergency Hospital of Bucharest, Romania (M.D.).

name: Harbor-University of California, Los Angeles Medical Center, Torrance, CA (W.J.F.).

name: TIMI Study Group, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (S.D.W., M.S.S.).

name: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Ontario, Canada (S.R.M.).

name: Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.).

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non–ST-Segment–Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

ReferenceCitation: Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Nicolau JC, Henry P, Kedev S, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Activated Clotting Time to Guide Heparin Dosing in Non-ST-Segment-Elevation Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention and Treated With IIb/IIIa Inhibitors: Impact on Ischemic and Bleeding Outcomes: Insights From the TAO Trial. Circ Cardiovasc Interv. 2018 Jun;11(6):e006084. doi: 10.1161/CIRCINTERVENTIONS.118.006084.

name: From the Department of Cardiology, CREATIF, Hôpital Lariboisière, AP-HP, Université Paris Diderot-Sorbonne Paris Cité, Inserm U-942, France (J.-G.D., P.H.)

name: FACT (French Alliance for Cardiovascular Trials), an F-CRIN network, DHU FIRE, Hôpital Bichat, AP-HP, Université Paris Diderot-Sorbonne Paris Cité, Inserm U-1148, France (G.D., Y.E., P.G.S.)

name: Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School, Newark (M.C.)

name: Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA (C.P.)

name: Heart Institute (InCor), University of São Paulo Medical School, Brazil (J.C.N.)

name: University Clinic of Cardiology, Medical Faculty, University of St. Cyril and Methodius, Skopje, Macedonia (S.K.)

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.D.W., M.S.S.)

name: McMaster University and the Population Health Research Institute, Hamilton Health Sciences, ON, Canada (S.R.M.)

title: Activated Clotting Time to Guide Heparin Dosing in Non–ST-Segment–Elevation Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention and Treated With IIb/IIIa Inhibitors

location_country: Macedonia, The Former Yugoslav Republic of

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title: Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy

summary:
Primary Objective:

To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide

Secondary Objectives:

To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide
To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide
To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide
To document the safety of Otamixaban as compared to UFH + eptifibatide
To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide


title: A Randomised Double-blind Cross-over Patient Preference Study of Pazopanib Versus Sunitinib in Treatment naïve Locally Advanced or Metastatic Renal Cell Carcinoma.

acronym: PISCES

summary: This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety.

ReferenceCitation: Lai JS, Beaumont JL, Diaz J, Khan S, Cella D. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma. Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.

name: Department of Medical Social Sciences; Northwestern University Feinberg School of Medicine; Chicago Illinois

family: Lai

full_name: Jin-Shei Lai

given: Jin-Shei

family: Beaumont

full_name: Jennifer L. Beaumont

given: Jennifer L.

family: Diaz

full_name: Jose Diaz

given: Jose

family: Khan

full_name: Sadya Khan

given: Sadya

family: Cella

full_name: David Cella

journal_name: Cancer

ReferenceCitation: Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Négrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol. 2014 May 10;32(14):1412-8. doi: 10.1200/JCO.2013.50.8267. Epub 2014 Mar 31.

name: Bernard Escudier, Institut Gustave Roussy, Villejuif; Emmanuel Sevin, Centre François Baclesse, Caen; Sylvie Négrier, Leon Berard Cancer Center, Lyon, France; Camillo Porta, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico S. Matteo, Pavia; Cora N. Sternberg, San Camillo Forlanini Hospital, Rome; Ugo De Giorgi, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; Petri Bono, Helsinki University Central Hospital, Helsinki, Finland;...

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Porta

full_name: Camillo Porta

given: Camillo

family: Bono

full_name: Petri Bono

given: Petri

family: Powles

full_name: Thomas Powles

given: Thomas

family: Eisen

full_name: Tim Eisen

given: Tim

family: Sternberg

full_name: Cora N. Sternberg

given: Cora N.

family: Gschwend

full_name: Jürgen E. Gschwend

given: Jürgen E.

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

family: Parikh

full_name: Omi Parikh

given: Omi

family: Hawkins

full_name: Robert Hawkins

given: Robert

family: Sevin

full_name: Emmanuel Sevin

family: Négrier

full_name: Sylvie Négrier

given: Sylvie

family: Redhu

full_name: Suman Redhu

given: Suman

family: Mehmud

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Randomized, Controlled, Double-Blind, Cross-Over Trial Assessing Treatment Preference for Pazopanib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma: PISCES Study

location_country:
Italy
Finland
France
Germany
United Kingdom


type: Registry Identifier

title: An Exploratory Trial to Assess Naturalistic Safety and Efficacy Outcomes in Patients With Moderate to Severe Plaque Psoriasis Transitiioned to Ustekinumab From Previous Methotrexate Therapy (TRANSIT)

acronym: TRANSIT

summary: This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.

location_country:
Austria
Sweden
Netherlands
Spain
Finland
France
Bulgaria
Greece
Israel
Lithuania
Norway
Hungary
Belgium
Poland
Slovakia
Portugal
Denmark
Germany
United Kingdom


location_country:
Peru
Romania
Belgium
Russian Federation
Croatia
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Hungary
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Estonia

location_facility: Municipal Clinical Hospital Filantropia; Oncology

location_facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Josa Andras Korhaz; Dept of Oncoradiology

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica

location_facility: Seoul National University Hosp; Dept Internal Med Hem Onc

location_facility: Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Uni Hospital For Tumours; Dept of Medical Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Semashko Central Clinical Hospital; Dept of Chemotherapy

location_facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Kaposi Mor County Hospital; Dept. of Oncology

location_facility: Oncologia Sul Capixaba Servicos Medicos - Oncosul

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: University Hospital of North Durham; Oncology

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

location_facility: Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica

location_facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Great Western Hospital; Clinical Oncology

location_facility: Korea University Guro Hospital; Oncology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: University Hospital; Oncology and Radiotherapy

location_facility: Spitalul Clinic Sf. Maria; Departmental De Oncologie

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Klinikum Bremen-Mitte gGmbH; Frauenklinik

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Instituto de Investigaciones Clínicas Quilmes

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica

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

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

location_facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

location_facility: Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Wojewodzki Szpital Zespolony; Oddzial Chemioterapii

location_facility: Royal Bournemouth General Hospital; Oncology

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Srinagarind Hospital; Department of Surgery

location_facility: A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Hospital of Aladar Petz; Dept of Oncoradiology

location_facility: Fejér Megyei Szent György Kórház; Onkológiai Osztály

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica II

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

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

location_facility: Hospital de Sagunto; Servicio de Oncologia

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Institute Of Oncology Bucharest; Medical Oncology

location_facility: S.-Peterburg Pavlov State Medical University ; Haematology

location_facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

location_facility: Regional Oncology Hospital of Krasnodar; Oncology

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: ASST DI CREMONA; Dipartimento Aziendale Oncologico

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Masarykuv onkologicky ustav; Oncology II

location_facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Istituto Regina Elena; Oncologia Medica A

source: euctr

title: A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting (PHEREXA)

summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.


lead_sponsor: Ipsen

primary_purpose: Diagnostic

location_country:
Italy
United Kingdom
Netherlands
France
Lithuania
Romania
Belgium
Spain
Denmark
Latvia

acronym: Triptocare

location_facility: IRCCS Fondazione S. Raffaele del Monte Tabor

title: Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study

summary: The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.


title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

acronym: Neptune

summary: Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

ReferenceCitation: van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.

ipd_sharing: Yes

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Italy
Austria
United Kingdom
Netherlands
France
Poland
Slovakia
Hungary
Belgium
Russian Federation
Belarus
Germany
Czech Republic