title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

summary: The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

ReferenceCitation: Rabe KF, Halpin DMG, Han MK, Miravitlles M, Singh D, Gronke L, Voss F, Martinez FJ. Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial. Respir Res. 2020 Jul 9;21(1):177. doi: 10.1186/s12931-020-01431-y.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

repositories_concat: PubMed Central;frl.publisso.de

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Tashkin DP, Miravitlles M, Celli BR, Metzdorf N, Mueller A, Halpin DMG, Anzueto A. Concomitant inhaled corticosteroid use and the risk of pneumonia in COPD: a matched-subgroup post hoc analysis of the UPLIFT(R) trial. Respir Res. 2018 Oct 5;19(1):196. doi: 10.1186/s12931-018-0874-0.

repository_institution: PubMed Central - Europe PMC

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

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Celli BR, Decramer M, Liu D, Metzdorf N, Asijee GM, Tashkin DP. Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT(R) trial. Respir Res. 2016 May 4;17(1):48. doi: 10.1186/s12931-016-0361-4.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Goossens LM, Leimer I, Metzdorf N, Becker K, Rutten-van Molken MP. Does the 2013 GOLD classification improve the ability to predict lung function decline, exacerbations and mortality: a post-hoc analysis of the 4-year UPLIFT trial. BMC Pulm Med. 2014 Oct 18;14:163. doi: 10.1186/1471-2466-14-163.

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

ReferenceCitation: Tashkin DP, Li N, Kleerup EC, Halpin D, Celli B, Decramer M, Elashoff R. Acute bronchodilator responses decline progressively over 4 years in patients with moderate to very severe COPD. Respir Res. 2014 Aug 31;15(1):102. doi: 10.1186/s12931-014-0102-5.

ReferenceCitation: Janssens W, Liu Y, Liu D, Kesten S, Tashkin DP, Celli BR, Decramer M. Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT(R)). Respir Med. 2013 Sep;107(9):1409-16. doi: 10.1016/j.rmed.2013.04.015. Epub 2013 May 25.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Tashkin DP, Celli BR, Decramer M, Lystig T, Liu D, Kesten S. Efficacy of tiotropium in COPD patients with FEV1 >/= 60% participating in the UPLIFT(R) trial. COPD. 2012 Jun;9(3):289-96. doi: 10.3109/15412555.2012.656211. Epub 2012 Mar 20.

ReferenceCitation: Kesten S, Celli B, Decramer M, Liu D, Tashkin D. Adverse health consequences in COPD patients with rapid decline in FEV1--evidence from the UPLIFT trial. Respir Res. 2011 Sep 28;12(1):129. doi: 10.1186/1465-9921-12-129.

ReferenceCitation: Tashkin D, Celli B, Kesten S, Lystig T, Decramer M. Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial. Respir Med. 2010 Oct;104(10):1495-504. doi: 10.1016/j.rmed.2010.03.033. Epub 2010 Apr 24.

ReferenceCitation: Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP, Decramer M; Uplift Investigators. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J. 2010 Jul;36(1):65-73. doi: 10.1183/09031936.00127809. Epub 2010 Feb 25.

ReferenceCitation: Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP; UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1171-8. doi: 10.1016/S0140-6736(09)61298-8. Epub 2009 Aug 27.

ReferenceCitation: Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.

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location_facility: 205.235.3033 Hospital General Carlos Haya

location_facility: 205.235.2705 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1203 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1404 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3607 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3511 Osmangazi Universitesi Tip Fakültesi

location_facility: 205.235.0424 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0433 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3602 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2407 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3003 Hospital Clínic i Provincial de Barcelona

location_facility: 205.235.3027 Complejo Asistencial Son Dureta

location_facility: 205.235.3707 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3719 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0301 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3509 Atatürk Üniversitesi Tip Fakultesi Aziziye

location_facility: 205.235.3800 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2803 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3205 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3208 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2804 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3763 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0202 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3004 Hospital General Universitario de Guadalajara

location_facility: 205.235.0804 Boehringer Ingelheim Investigational Site

location_facility: 205.235.104 Hospital de Clinicas José de San Martín

location_facility: 205.235.1308 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3752 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3760 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0723 Office of Pulmonary and Respiratory Diseases

location_facility: 205.235.3009 Hospital Clínico San Carlos

location_facility: 205.235.3716 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3201 Boehringer Ingelheim Investigational Site

location_facility: 205.235.514 Unidade de Coracao e Pulmao do Dto. de Medicina

location_facility: 205.235.3747 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3722 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1201 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1108 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3717 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3813 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3803 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2404 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3784 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0704 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2301 Philippine General Hospital

location_facility: 205.235.2602 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3791 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3804 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3730 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1402 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2402 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2102 Martini Ziekenhuis Groningen

location_facility: 205.235.3401 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3732 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2701 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3303 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3037 Hsopital Universitario Ntra. Sra. de la Candelaria

location_facility: 205.235.1306 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0303 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0707 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2305 University of Santo Tomas Hospital

location_facility: 205.235.1305 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0726 Private Office of Pulmonary Diseases

location_facility: 205.235.3011 Complejo Hospitalario Infanta Cristina

location_facility: 205.235.3502 Yedikule Gögüs Hastaliklari Hastanesi

location_facility: 205.235.2406 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3795 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1307 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3613 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3799 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1113 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0211 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0206 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1304 Boehringer Ingelheim Investigational Site

location_facility: 205.235.3028 Hospital Universitario de la Princesa

location_facility: 205.235.0422 Boehringer Ingelheim Investigational Site

location_facility: 205.235.0409 Boehringer Ingelheim Investigational Site

location_facility: 205.235.1006 Centre Hospitalier de Chauny

location_facility: 205.235.3026 Hospital General Universitario de Alicante

location_facility: 205.235.3797 Boehringer Ingelheim Investigational Site

location_facility: 205.235.2405 Boehringer Ingelheim Investigational Site


title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)

summary: The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

status: Completed

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Mikl J, Sulkowski MS, Benhamou Y, Dieterich D, Pol S, Rockstroh J, Robinson PA, Ranga M, Stern JO. Hepatic profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009 Dec 14;9:203. doi: 10.1186/1471-2334-9-203.

ReferenceCitation: Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75. doi: 10.1016/S0140-6736(06)69154-X.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Argentina
Denmark
Brazil
Netherlands
Austria
Belgium
Mexico
Sweden
Spain
Switzerland
Greece
France

location_facility: 1182.48.4903 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3316 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3202 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3404 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3001 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3009 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4929 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3909 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4920 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3206 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4412 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3003 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3104 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM

location_facility: 1182.48.3915 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4501 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3926 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3414 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4919 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3005 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3416 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3924 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3531 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3408 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3902 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3210 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3402 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3409 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4905 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4409 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4602 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3501 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3914 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4915 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3410 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3322 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3910 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4921 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4902 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4913 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde

location_facility: 1182.48.3323 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3417 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3406 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4931 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC

location_facility: 1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d

location_facility: 1182.48.4906 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4405 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4907 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4918 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3921 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3321 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3908 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3301 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3108 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3503 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3317 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4407 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4926 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3401 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3010 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4914 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4916 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3920 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3004 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3318 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4404 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3314 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4909 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4910 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3931 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3413 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3407 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas

location_facility: 1182.48.3932 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4406 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4912 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3201 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4502 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3002 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3310 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3934 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4418 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3304 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4411 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3308 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3320 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4104 Hopital Universitaire de Genève

location_facility: 1182.48.3309 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4928 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5406 Servicio de Immunocomprometido

location_facility: 1182.48.3403 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3925 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4601 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3930 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4923 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3305 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3907 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3415 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3207 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3502 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3906 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3927 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3929 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3420 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3302 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3904 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3209 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3319 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3935 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3922 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3411 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4417 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3306 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3105 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3303 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3311 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3917 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

location_facility: 1182.48.3412 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4901 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3101 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4904 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4603 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3008 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3312 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4911 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3933 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4414 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: 1182.48.3405 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3919 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3106 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE

location_facility: 1182.48.3418 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5506 Centro de Referência e Treinamento - DST/AIDS

location_facility: 1182.48.3307 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3313 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3905 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5509 Universidade Federal do Rio de Janeiro

location_facility: 1182.48.4301 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3007 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4930 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4408 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4908 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4927 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4504 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3110 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.5513 UNIFESP - Centro de Pesquisa Clinica

location_facility: 1182.48.3006 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3903 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.3315 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4505 Boehringer Ingelheim Investigational Site

location_facility: 1182.48.4924 Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer

summary: To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).

study_completion_date_type: Actual

design_allocation: Randomized

lead_sponsor: Pfizer

location_country:
Germany
Italy
Poland
Russian Federation
Netherlands
Austria
Belgium
Switzerland
Spain
Taiwan
Czech Republic
Egypt
France


title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial

acronym: PREPS EXT

summary: To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

design_allocation: Non-Randomized

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country: Finland Poland Portugal Switzerland Belgium France


title: Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial

summary: To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.

sponsor_collaborators: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Finland
Poland
Portugal
United Kingdom
Netherlands
Switzerland
Belgium
France


title: A Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

summary: The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.

ReferenceCitation: Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32.

ReferenceCitation: Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007 Nov 24;370(9601):1757-63. doi: 10.1016/S0140-6736(07)61744-9.

ReferenceCitation: Vesikari T, Prymula R, Schuster V, Tejedor JC, Cohen R, Bouckenooghe A, Damaso S, Han HH. Efficacy and immunogenicity of live-attenuated human rotavirus vaccine in breast-fed and formula-fed European infants. Pediatr Infect Dis J. 2012 May;31(5):509-13. doi: 10.1097/INF.0b013e3182489cac.

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
Italy
Germany
Spain
Czech Republic
France

intervention_type: Biological


title: A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

summary: The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

ReferenceType: result

ReferenceCitation: Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.

lead_sponsor: MedImmune LLC

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Hungary
Denmark
United States
Iceland
Italy
United Kingdom
Sweden
Austria
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Multifunctional Hospital for Active Treatment "St. Marina"

location_facility: Zentrum Klinische Studien/Universtatsklinikum Freiburg

location_facility: Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna

location_facility: Hospital Universitario de Universidade de Sao Paulo

location_facility: Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi

location_facility: Universitatskinderlinik/Zentrum Fur klinische Studien

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Centre Hospitalier de L'Universite Laval

location_facility: Katedra i Klinika Neonatologii AM w Poznaniu

location_facility: Manitoba Institute Of Child Health University of Manitoba

location_facility: Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza

location_facility: Szpital Morski im. PCK, Oddział Dziecięcy

location_facility: Georgia Pediatric Pulmonology Associates

location_facility: Nemours Children's Clinic Biomedical Research

location_facility: Shands Hospital At The University Of Florida

location_facility: Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital

location_facility: Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka

location_facility: Hippokration Hospital, University of Thessaloniki

location_facility: University Of Texas Health Science Center

location_facility: Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin

location_facility: Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"

location_facility: Wake Forest University School of Medicine

location_facility: Pediatric Clinical Trials International, Inc.

location_facility: University Hospital State University of New York at Stony Brook Department of Pediatrics

location_facility: Children's Hospital Medical Center Of Akron

location_facility: Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo

location_facility: CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B

location_facility: Univ. Of Texas Southwestern Medical Center

location_facility: Aristotele University of Thessaloniki, General "AXEPA" Hospital

location_facility: University Of Texas Houston Medical School

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi

location_facility: Saint-Petersburg State Pediatric Medical Academy

location_facility: University of Michigan Mott Children's Hospital

location_facility: Hospital Peiade Interzonal General de Augodos

location_facility: James Whitcomb Riley Hospital for Children

location_facility: University of North Carolina-School of Medicine

location_facility: Service de Medecine Neonatale et de reanimation pediatrique

location_facility: Geisinger Medical Center- JW Children's Hospital

location_facility: Specialized Hospital for Active Treatment of Pediatric Diseases

location_facility: Hospital Clinico Universitario de Valencia

location_facility: St. Petersburg State Pediatric Medical Academy

location_facility: St. Petersburg City Outpatient Hospital #45

location_facility: Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Beehly Medical Park Women's and Children's Pav.

location_facility: Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Hospital General De Ninos Pedro De Elizalde

location_facility: Univ. S. Florida Pediatrics Ambulatory Care Center

location_facility: II Klinika Chorób Dzieci PAM, Samodzielny Publiczny

location_facility: Hospital Das Clinicas Da Faculdade De Medicina

location_facility: Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"

location_facility: Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Azienda USL di Imola - Ospedale di Imola

location_facility: Louisiana State University MidCity Clinic

location_facility: Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale

location_facility: University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic

location_facility: Hospital Clinico de la Universidad de Chile

location_facility: Klinik und Poliklinik und Jugendiche der Universitat Leipzig

location_facility: Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie

location_facility: Allgemeines KrankenHaus Universitatsklinkiken Wein

location_facility: Fakultni Thomayerova nemocnice S poliklinkou

location_facility: Specialized Hospital for Active Treatment of Cardio-vascular Diseases

location_facility: McGill University Health Centre Monteal Children's Hospital

location_facility: Asklepios Kinderklinik Sankt Augustin GmbH

location_facility: Kapiolani Medical Center for Woman and Children

location_facility: University Of Alberta/Stollery Children's Hospital

location_facility: University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics

location_facility: CHU Montpellier/Hoptial Arnaud de Villeneuve

location_facility: Children's hospital, Landspitali University Hospital

location_facility: Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale

location_facility: Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii

location_facility: Centre Pediatrique Gatien de Clocheville

location_facility: University Of Maryland School of Medicine

location_facility: Multifunctional Hospital for Active Treatment "Pleven"

location_facility: Hospital Clinic y Maternistat - Barcelona

location_facility: Multifunctional Hospital for Active Treatment - Plovdiv

location_facility: Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki

location_facility: East Carolina University School of Medicine

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara

location_facility: Universitatsklinik fur Kinder und Jugenheilkunde, Graz

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii

location_facility: Queen's Medical Centre Nottingham University Hospital

location_facility: Hospital Materno Infantil/Neumología pediátrica

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Paediatrisk Afdeling Herning Centralsygehus

location_facility: Hospital e Maternidade Celso Pierro-Puccamp

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.

location_facility: Sioux Valley Hospital University of South Dakota Medical Center

location_facility: The Children's Clinic Of Jonesboro, P.A.

location_facility: Children's Healthcare D.B.A. Hospitals & Clinics

location_facility: University of Nebraska Medical Center Pediatric

location_facility: Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy

location_facility: Jefferson-duPont Children's Health Program


title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension

summary: The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Sanofi

location_country:
Germany
Israel
Netherlands
Belgium
United States
Canada
Russian Federation
France


title: Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

summary: The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.

ReferenceCitation: Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.

ReferenceCitation: Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15.

ReferenceCitation: McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010.

ReferenceCitation: Carson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432.

ReferenceCitation: McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4.

ReferenceCitation: Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

unpaywall_oa_status: hybrid

ReferenceCitation: Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.

oa_host_type: repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kristensen SL, Mogensen UM, Jhund PS, Petrie MC, Preiss D, Win S, Kober L, McKelvie RS, Zile MR, Anand IS, Komajda M, Gottdiener JS, Carson PE, McMurray JJ. Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction). Circulation. 2017 Feb 21;135(8):724-735. doi: 10.1161/CIRCULATIONAHA.116.024593. Epub 2017 Jan 4.

oa_colors: green other

ReferenceCitation: Gandhi PU, Chow SL, Rector TS, Krum H, Gaggin HK, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Carson PE, Januzzi JL Jr, Anand IS. Prognostic Value of Insulin-Like Growth Factor-Binding Protein 7 in Patients with Heart Failure and Preserved Ejection Fraction. J Card Fail. 2017 Jan;23(1):20-28. doi: 10.1016/j.cardfail.2016.06.006. Epub 2016 Jun 16.

oa_host_type: closed

ReferenceCitation: Badar AA, Perez-Moreno AC, Hawkins NM, Jhund PS, Brunton AP, Anand IS, McKelvie RS, Komajda M, Zile MR, Carson PE, Gardner RS, Petrie MC, McMurray JJ. Clinical Characteristics and Outcomes of Patients With Coronary Artery Disease and Angina: Analysis of the Irbesartan in Patients With Heart Failure and Preserved Systolic Function Trial. Circ Heart Fail. 2015 Jul;8(4):717-24. doi: 10.1161/CIRCHEARTFAILURE.114.002024. Epub 2015 Jun 11.

ReferenceCitation: Oluleye OW, Rector TS, Win S, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Massie B, Carson PE, Anand IS. History of atrial fibrillation as a risk factor in patients with heart failure and preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):960-6. doi: 10.1161/CIRCHEARTFAILURE.114.001523. Epub 2014 Sep 15.

repository_institution: Australian Catholic University - Research Bank

ReferenceCitation: Bohm M, Perez AC, Jhund PS, Reil JC, Komajda M, Zile MR, McKelvie RS, Anand IS, Massie BM, Carson PE, McMurray JJ; I-Preserve Committees and Investigators. Relationship between heart rate and mortality and morbidity in the irbesartan patients with heart failure and preserved systolic function trial (I-Preserve). Eur J Heart Fail. 2014 Jul;16(7):778-87. doi: 10.1002/ejhf.85. Epub 2014 May 23.

publisher_dissemination: Wiley

ReferenceCitation: Lam CS, Carson PE, Anand IS, Rector TS, Kuskowski M, Komajda M, McKelvie RS, McMurray JJ, Zile MR, Massie BM, Kitzman DW. Sex differences in clinical characteristics and outcomes in elderly patients with heart failure and preserved ejection fraction: the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2012 Sep 1;5(5):571-8. doi: 10.1161/CIRCHEARTFAILURE.112.970061. Epub 2012 Aug 10.

ReferenceCitation: Rector TS, Carson PE, Anand IS, McMurray JJ, Zile MR, McKelvie RS, Komajda M, Kuskowski M, Massie BM; I-PRESERVE Trial Investigators. Assessment of long-term effects of irbesartan on heart failure with preserved ejection fraction as measured by the minnesota living with heart failure questionnaire in the irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial. Circ Heart Fail. 2012 Mar 1;5(2):217-25. doi: 10.1161/CIRCHEARTFAILURE.111.964221. Epub 2012 Jan 20.

ReferenceCitation: Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.

ReferenceCitation: Krum H, Elsik M, Schneider HG, Ptaszynska A, Black M, Carson PE, Komajda M, Massie BM, McKelvie RS, McMurray JJ, Zile MR, Anand IS. Relation of peripheral collagen markers to death and hospitalization in patients with heart failure and preserved ejection fraction: results of the I-PRESERVE collagen substudy. Circ Heart Fail. 2011 Sep;4(5):561-8. doi: 10.1161/CIRCHEARTFAILURE.110.960716. Epub 2011 Jul 12.

ReferenceCitation: Anand IS, Rector TS, Cleland JG, Kuskowski M, McKelvie RS, Persson H, McMurray JJ, Zile MR, Komajda M, Massie BM, Carson PE. Prognostic value of baseline plasma amino-terminal pro-brain natriuretic peptide and its interactions with irbesartan treatment effects in patients with heart failure and preserved ejection fraction: findings from the I-PRESERVE trial. Circ Heart Fail. 2011 Sep;4(5):569-77. doi: 10.1161/CIRCHEARTFAILURE.111.962654. Epub 2011 Jun 29.

ReferenceCitation: Haass M, Kitzman DW, Anand IS, Miller A, Zile MR, Massie BM, Carson PE. Body mass index and adverse cardiovascular outcomes in heart failure patients with preserved ejection fraction: results from the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2011 May;4(3):324-31. doi: 10.1161/CIRCHEARTFAILURE.110.959890. Epub 2011 Feb 24.

ReferenceCitation: Komajda M, Carson PE, Hetzel S, McKelvie R, McMurray J, Ptaszynska A, Zile MR, Demets D, Massie BM. Factors associated with outcome in heart failure with preserved ejection fraction: findings from the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE). Circ Heart Fail. 2011 Jan;4(1):27-35. doi: 10.1161/CIRCHEARTFAILURE.109.932996. Epub 2010 Nov 10.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa
Russian Federation
Sweden


title: An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia

summary: This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Poland
Australia
Thailand
France
Czech Republic
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Puerto Rico
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Panama
South Africa
Taiwan
Russian Federation
Sweden


title: A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

summary: This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

ReferenceCitation: Antonanzas F, Brenes F, Molero JM, Fernandez-Pro A, Huerta A, Palencia R, Cozar JM. [Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. Actas Urol Esp. 2011 Feb;35(2):65-71. doi: 10.1016/j.acuro.2010.11.008. Epub 2011 Jan 26. Spanish.

ReferenceCitation: Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.

ReferenceCitation: Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial. BJU Int. 2012 Mar;109(5):731-8. doi: 10.1111/j.1464-410X.2011.10511.x. Epub 2011 Sep 20.

ReferenceCitation: Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.

ReferenceCitation: Chung BH, Roehrborn CG, Siami P, Major-Walker K, Morrill BB, Wilson TH, Montorsi F. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH. Prostate Cancer Prostatic Dis. 2009;12(2):152-9. doi: 10.1038/pcan.2008.49. Epub 2008 Sep 23.

ReferenceCitation: Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19. Erratum In: Eur Urol. 2010 Nov;58(5):801.

ReferenceCitation: Roehrborn CG, Andriole GL, Wilson TH, Castro R, Rittmaster RS. Effect of dutasteride on prostate biopsy rates and the diagnosis of prostate cancer in men with lower urinary tract symptoms and enlarged prostates in the Combination of Avodart and Tamsulosin trial. Eur Urol. 2011 Feb;59(2):244-9. doi: 10.1016/j.eururo.2010.10.040. Epub 2010 Nov 4.

ReferenceCitation: Roehrborn CG, Barkin J, Siami P, Tubaro A, Wilson TH, Morrill BB, Gagnier RP. Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial. BJU Int. 2011 Mar;107(6):946-54. doi: 10.1111/j.1464-410X.2011.10124.x. Epub 2011 Feb 18.

ReferenceCitation: Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. 2012 May;187(5):1732-8. doi: 10.1016/j.juro.2011.12.083. Epub 2012 Mar 15.

ReferenceCitation: Becher E, Roehrborn CG, Siami P, Gagnier RP, Wilson TH, Montorsi F. The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study. Prostate Cancer Prostatic Dis. 2009;12(4):369-74. doi: 10.1038/pcan.2009.37. Epub 2009 Sep 1.

ReferenceCitation: Montorsi F, Roehrborn C, Garcia-Penit J, Borre M, Roeleveld TA, Alimi JC, Gagnier P, Wilson TH. The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. BJU Int. 2011 May;107(9):1426-31. doi: 10.1111/j.1464-410X.2011.10129.x. Epub 2011 Feb 23.

ReferenceCitation: Montorsi F, Henkel T, Geboers A, Mirone V, Arrosagaray P, Morrill B, Black L. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Int J Clin Pract. 2010 Jul;64(8):1042-51. doi: 10.1111/j.1742-1241.2010.02428.x. Epub 2010 May 7.

ReferenceCitation: Haillot O, Fraga A, Maciukiewicz P, Pushkar D, Tammela T, Hofner K, Chantada V, Gagnier P, Morrill B. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):302-6. doi: 10.1038/pcan.2011.13. Epub 2011 Apr 19.

ReferenceCitation: Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21. Erratum In: J Urol. 2008 Sep;180(3):1191.

location_country:
Finland
Germany
Poland
Argentina
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Iceland
Romania
Tunisia
Belgium
Estonia
Puerto Rico
Philippines
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL

summary: The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

study_start_date_type: Actual

ReferenceCitation: Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.

collaborators:
Biogen
Genentech, Inc.

sponsor_collaborators:
Hoffmann-La Roche
Biogen
Genentech, Inc.

location_country:
Italy
Poland
New Zealand
Hungary
Norway
Denmark
Australia
Romania
Netherlands
Sweden
Belgium
United Kingdom
United States
Spain
Canada
Russian Federation
France

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

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre; Hematology

location_facility: Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA

location_facility: State Medical Inst. Municipal Hospital #31; Oncology & Hematology Dept. With the Usechemo. in Adult

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Haematology Research Center; Haematology

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: Hopital Clemenceau; Hematologie Clinique

location_facility: Mater Hospital; Division of Cancer Services

location_facility: Hôpital Lapeyronie; Hématologie Oncologie Médicale

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Akademii Medycznej W; Klinika Hematologii

location_facility: Medical University School; Dept. of Haematology

location_facility: Ospedale S. Eugenio; Divisione Di Ematologia

location_facility: Karolinska Inst. , Huddinge Uni Hospital; Depart. of Hematology

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Hopital Avicenne; Hematologie Biologique

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Pinderfields General Hospital; Dept of Haematology

location_facility: Klin. Chorob Wewnetrznych I Hemat. Z Osrodkiem Transplant. Szpiku

location_facility: The Ottawa Regional Hospital - General Campus; Division of Hematology, Box 704

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

location_facility: Academisch Medisch Centrum Universiteit Amsterdam

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: Rush-Presbyterian St. Luke'S Medical Center

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Regional Clinical Hospital; Hematology Dept. #2 For B M Transplantation & High Dose Chemo.

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

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Wellington Hospital; Regional Oncology Unit

location_facility: Milton S. Hershey Medical Center; Penn State Cancer Inst.

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

location_facility: University of Szeged, II Dept of Internal Medicine

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Országos Gyógyintézeti Központ; Haematologiai Osztaly

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis

location_facility: California Cancer Center Woodward Park; Community Medical Centers

location_facility: Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Haukeland Universitetshospital; Medicine Dept

location_facility: Royal Marsden Hospital; Academic Dept of Haematology

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: St. Bartholomew'S Hospital; Dept of Medical Oncology

location_facility: Uni of Debrecen; 2Nd Clinic of Internal Medicine

location_facility: Hopital Edouard Herriot; Bat.E-Hematologie

location_facility: Royal Bournemouth General Hospital; Haematology

location_facility: City Clinical Botkin's Hospital; City Hematological Center

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Chu La Miletrie; Hdj Cons Hemato Cancerologie

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Research Inst. Hematology /Blood Transfusion ; Hemablastosis, Supression Hemopoesis & B M Transplant

location_facility: Christchurch Hospital; Canterbury Health Laboratories

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Universitetssjukhuset i Linköping, Hematologkliniken

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Pacific Coast Hematology/Oncology Medical Group

location_facility: Regional Clinical Hospital N.A. Kalinin; Hematology Dept

location_facility: Instytut Hematologii I Transfuzjologii; Klinika Chorob Wewnetrznych I Hematologii

location_facility: Royal Liverpool Uni Hospital; Haematology

location_facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R

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

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service


title: A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults

summary: The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

location_country:
Finland
Germany
New Zealand
Argentina
Australia
Brazil
Thailand
Chile
Czechia
Canada
France
Slovenia
Portugal
Hungary
Hong Kong
United States
Latvia
India
Romania
Belgium
Malaysia
Estonia
Puerto Rico
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


title: A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen

summary:
PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy

lead_sponsor: Agennix

location_country:
Germany
Italy
Poland
Hungary
Argentina
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
Croatia
Peru
Russian Federation
France

location_facility: Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny

location_facility: Hospital Italiano de Cordoba Dept. Oncology

location_facility: Hematology/Oncology Group of South Florida

location_facility: Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut

location_facility: Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK

location_facility: Hematology and Oncology Associates of Northeastern PA / PC

location_facility: Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia

location_facility: Salisbury Investigaciones Clinicas del Grupo CER S.A.

location_facility: Institut Jules Bordet Service de Chimiothérapie

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: Universitätsklinikum der Carl-Gustav-Carus Universität

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg

location_facility: Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny

location_facility: LSU Health Science Center, Stanley S. Scott Cancer Center

location_facility: Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica

location_facility: Istituto Nazionale per la Ricerca sul Cancro (IST)

location_facility: Hospital Clínico San Carlos, Sevicio de Oncología Médica

location_facility: Klinickum der Johannes-Gutenberg Universitat

location_facility: Clinica Universitaria de Navarra, Sevicio de Oncología Médica

location_facility: Hospital Ein Kerem Asaf Harofeh Medical Center

location_facility: Hospital Italiano Regional del Sur Dept. Oncology

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica

location_facility: Hôpital Saint-Louis: Service de Radiotherapy

location_facility: St. Bartholomew's Hospital Dept. of Medical Oncology

location_facility: University of California Davis Cancer Center, Division of Hematology-Oncology

location_facility: Instituto Valenciano de Oncología: Sevicio de Oncología Médica

location_facility: Centre Antoine Lacassagne Oncologie medicale

location_facility: Maine Center for Cancer Medicine & Blood Disorders

location_facility: Oncology and Hematology Associates of West Broward P.A.

location_facility: Hematology Oncology Associates of South Texas

location_facility: Clinical Hospital Split Department of Oncology and Radiotherapy

location_facility: St George's Healthcare Dept of Oncology, Tooting

location_facility: Stadtische Klinicen Frankfurt a.M. Hochst

location_facility: Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut

location_facility: Northern AZ Hematology & Oncology Assoc.

location_facility: Sharp Healthcare - Clinical Oncology Research

location_facility: University of Pittsburgh Cancer Institute- Hillman Cancer Center

location_facility: Innovative Medical Research of South Florida

location_facility: Academisch Ziekenhuis Nijmegen: Urology Department

location_facility: Universita degli Studi di Napoli Federico II-Nuovo Policlinico

location_facility: Clinical Hostpital Rebro Department of Oncology

location_facility: Nebraska Methodist Hospital Cancer Center

location_facility: Medical Radilogical Research Center of Rams

location_facility: Klinikum der Philipps - Universitat Marburg

location_facility: Academic Hospital of the University of Amsterdam

location_facility: Policlinica Bancaria "9 de Julio" Av. Gaona 2197

location_facility: Texas Oncology, P.A. - Deke Slayton Cancer Center

location_facility: Streekziekenhuis Koningin : Dept. Urology

location_facility: Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie

location_facility: Karmanos Cancer Institute, Wayne State University

location_facility: Hospital Clinic i Provincial, Sevicio de Oncología Médica

location_facility: Hematology/Oncology Associates of Treasure Coast


title: A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

summary: This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

location_country:
Finland
Germany
Ireland
New Zealand
Australia
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
China
Puerto Rico
Italy
Guatemala
Norway
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Russian Federation
Israel


title: Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer

summary:
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.

ReferenceCitation: Van Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010 Oct 10;28(29):4450-6. doi: 10.1200/JCO.2010.30.3446. Epub 2010 Sep 13.

ReferenceCitation: Van Laethem JL, Mornex F, Azria D, et al.: Adjuvant gemcitabine alone versus gemcitabine-based chemoradiation after curative resection for pancreatic cancer: updated results of a randomized EORTC/FFCD/GERCOR phase II study (40013-22012/9203). [Abstract] J Clin Oncol 27 (Suppl 15): A-4527, 2009.

ReferenceCitation: Van Laethem J, Van Cutsem E, Hammel P, et al.: Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). [Abstract] J Clin Oncol 26 (Suppl 15): A-4514, 2008.

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

collaborators: Federation Francophone de Cancerologie Digestive

location_country: Germany France Netherlands Switzerland Belgium Israel

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

location_facility: Centre Hospital Regional Universitaire de Limoges