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A physician-initiated double-blind, randomised, placebo-controlled, phase 2 study evaluating the efficacy and safety of inhibition of NADPH oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excretion: Protocol and statistical considerations.
Reutens, Anne T; Jandeleit-Dahm, Karin; Thomas, Merlin; Salim, Agus; De Livera, Alysha M; Bach, Leon A; Colman, Peter G; Davis, Timothy M E; Ekinci, Elif I; Fulcher, Greg; Hamblin, Peter Shane; Kotowicz, Mark A; MacIsaac, Richard J; Morbey, Claire; Simmons, David; Soldatos, Georgia; Wittert, Gary; Wu, Ted; Cooper, Mark E; Shaw, Jonathan E.
Afiliación
  • Reutens AT; Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: anne.reutens@baker.edu.au.
  • Jandeleit-Dahm K; Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: karin.jandeleit-dahm@monash.edu.
  • Thomas M; Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: merlin.thomas@monash.edu.
  • Salim A; Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: Agus.Salim@baker.edu.au.
  • De Livera AM; Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: Alysha.deLivera@baker.edu.au.
  • Bach LA; Department of Endocrinology and Diabetes, Level 5 Centre Block, The Alfred, PO Box 315, Prahran, VIC 3181, Australia; Monash University, Department of Medicine, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: l.bach@alfred.org.
  • Colman PG; Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, RMH VIC 3050, Australia. Electronic address: peter.colman@mh.org.au.
  • Davis TME; University of Western Australia, Medical School, Fremantle Hospital, PO Box 480, Fremantle, WA 6959, Australia. Electronic address: tim.davis@uwa.edu.au.
  • Ekinci EI; Department of Medicine, The University of Melbourne and Department of Endocrinology, Austin Health, Heidelberg Repatriation Hospital, Department of Medicine, Boronia Building, Level 1, 300 Waterdale Rd, Heidelberg, VIC 3081, Australia. Electronic address: elif.ekinci@unimelb.edu.au.
  • Fulcher G; Department of Endocrinology, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards, NSW 2065, Australia; The University of Sydney NSW 2006, Australia. Electronic address: greg.fulcher@sydney.edu.au.
  • Hamblin PS; Diabetes & Endocrinology Centre, Sunshine Hospital, 176 Furlong Road, St Albans, VIC 3021, Australia; Department of Medicine-Western Precinct, University of Melbourne, St Albans, VIC 3021, Australia. Electronic address: Peter.Hamblin@wh.org.au.
  • Kotowicz MA; Deakin University, Geelong, VIC, Australia. Electronic address: markk@barwonhealth.org.au.
  • MacIsaac RJ; Department of Endocrinology & Diabetes, Level 4 Daly Wing, St Vincent's Hospital, University of Melbourne, PO Box 2900, Fitzroy, VIC 3065, Australia. Electronic address: richard.macisaac@svha.org.au.
  • Morbey C; Hunter Diabetes Centre, Level 1, 41 Llewellyn Street, Merewether, NSW 2291, Australia. Electronic address: drmorbey@hunterdiabetes.com.au.
  • Simmons D; School of Medicine, Western Sydney University, Campbelltown Hospital, Therry Rd, Campbelltown, NSW 2560, Australia. Electronic address: da.simmons@westernsydney.edu.au.
  • Soldatos G; Diabetes and Vascular Medicine Unit, Monash Health, 246 Clayton Road, Clayton, VIC 3168, Australia. Electronic address: Georgia.Soldatos@monashhealth.org.
  • Wittert G; Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building, Corner of North Terrace and George Street, Adelaide, SA 5005, Australia. Electronic address: gary.wittert@adelaide.edu.au.
  • Wu T; Diabetes Centre, Level 6, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia; The University of Sydney NSW 2006, Australia. Electronic address: Ted.Wu@health.nsw.gov.au.
  • Cooper ME; Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: mark.cooper@monash.edu.
  • Shaw JE; Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia. Electronic address: jonathan.shaw@baker.edu.au.
Contemp Clin Trials ; 90: 105892, 2020 03.
Article en En | MEDLINE | ID: mdl-31740428
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 1_ASSA2030 / 2_ODS3 / 6_ODS3_enfermedades_notrasmisibles Problema de salud: 1_doencas_nao_transmissiveis / 2_muertes_prematuras_enfermedades_notrasmisibles / 6_diabetes / 6_endocrine_disorders / 6_other_malignant_neoplasms / 6_sense_organ_diseases Asunto principal: Piridonas / NADPH Oxidasas / Pirazolonas / Diabetes Mellitus Tipo 1 / Nefropatías Diabéticas / Albuminuria Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2020 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 1_ASSA2030 / 2_ODS3 / 6_ODS3_enfermedades_notrasmisibles Problema de salud: 1_doencas_nao_transmissiveis / 2_muertes_prematuras_enfermedades_notrasmisibles / 6_diabetes / 6_endocrine_disorders / 6_other_malignant_neoplasms / 6_sense_organ_diseases Asunto principal: Piridonas / NADPH Oxidasas / Pirazolonas / Diabetes Mellitus Tipo 1 / Nefropatías Diabéticas / Albuminuria Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2020 Tipo del documento: Article