title: A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]

acronym: PLATO

summary: Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

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ReferenceCitation: Samman KN, Mehanna P, Takla E, Grenier JC, Chan MY, Lopes RD, Neely ML, Wang TY, Newby LK, Becker RC, Lordkipanidze M, Ruiz M, Hussin JG, Jolicoeur EM. Differential modulation of polyunsaturated fatty acids in patients with myocardial infarction treated with ticagrelor or clopidogrel. Cell Rep Med. 2021 Jun 4;2(6):100299. doi: 10.1016/j.xcrm.2021.100299. eCollection 2021 Jun 15.

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ReferenceCitation: Thi Thu Nguyen T, Van Do D, Mellstrom C, Quang Nguyen T, Manh Pham H, Van Hoang S, Cong Luu T, Le Phuong T. Cost-Effectiveness of Ticagrelor Compared with Clopidogrel in Patients with Acute Coronary Syndrome from Vietnamese Healthcare Payers' Perspective. Adv Ther. 2021 Jul;38(7):4026-4039. doi: 10.1007/s12325-021-01743-5. Epub 2021 Jun 11.

ReferenceCitation: Mahmoodi BK, Eriksson N, Vos GJA, Meijer K, Siegbahn A, James S, Wallentin L, Ten Berg JM. Factor V Leiden Does Not Modify the Phenotype of Acute Coronary Syndrome or the Extent of Myocardial Necrosis. J Am Heart Assoc. 2021 Jun;10(11):e020025. doi: 10.1161/JAHA.120.020025. Epub 2021 May 17.

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ReferenceCitation: Gregersen I, Michelsen AE, Lunde NN, Akerblom A, Lakic TG, Skjelland M, Ryeng Skagen K, Becker RC, Lindback J, Himmelmann A, Solberg R, Johansen HT, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Ueland T, Wallentin L, Halvorsen B. Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2020 Sep;9(17):e016360. doi: 10.1161/JAHA.120.016360. Epub 2020 Aug 15.

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ReferenceCitation: Sumaya W, Wallentin L, James SK, Siegbahn A, Gabrysch K, Himmelmann A, Ajjan RA, Storey RF. Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome Patients with Diabetes: A PLATO Sub-Study. Thromb Haemost. 2020 Mar;120(3):412-422. doi: 10.1055/s-0039-1701011. Epub 2020 Jan 23.

ReferenceCitation: Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Becker RC, Bertilsson M, Budaj A, Cornel JH, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Aukrust P, Wallentin L; PLATO Investigators. ALCAM predicts future cardiovascular death in acute coronary syndromes: Insights from the PLATO trial. Atherosclerosis. 2020 Jan;293:35-41. doi: 10.1016/j.atherosclerosis.2019.11.031. Epub 2019 Nov 29.

ReferenceCitation: Andersen T, Ueland T, Ghukasyan Lakic T, Akerblom A, Bertilsson M, Aukrust P, Michelsen AE, James SK, Becker RC, Storey RF, Wallentin L, Siegbahn A, Kontny F. C-X-C Ligand 16 Is an Independent Predictor of Cardiovascular Death and Morbidity in Acute Coronary Syndromes. Arterioscler Thromb Vasc Biol. 2019 Nov;39(11):2402-2410. doi: 10.1161/ATVBAHA.119.312633. Epub 2019 Sep 26.

ReferenceCitation: Akerblom A, Wojdyla DM, Wallentin L, James SK, de Souza Brito F, Steg PG, Cannon CP, Katus HA, Himmelmann A, Storey RF, Becker RC, Lopes RD; PLATO Investigators. Ticagrelor in patients with heart failure after acute coronary syndromes-Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2019 Jul;213:57-65. doi: 10.1016/j.ahj.2019.04.006. Epub 2019 Apr 18.

ReferenceCitation: Franchi F, James SK, Ghukasyan Lakic T, Budaj AJ, Cornel JH, Katus HA, Keltai M, Kontny F, Lewis BS, Storey RF, Himmelmann A, Wallentin L, Angiolillo DJ; PLATO Investigators. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial. J Am Heart Assoc. 2019 Mar 19;8(6):e011139. doi: 10.1161/JAHA.118.011139.

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ReferenceCitation: Lindholm D, James SK, Gabrysch K, Storey RF, Himmelmann A, Cannon CP, Mahaffey KW, Steg PG, Held C, Siegbahn A, Wallentin L. Association of Multiple Biomarkers With Risk of All-Cause and Cause-Specific Mortality After Acute Coronary Syndromes: A Secondary Analysis of the PLATO Biomarker Study. JAMA Cardiol. 2018 Dec 1;3(12):1160-1166. doi: 10.1001/jamacardio.2018.3811.

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

ReferenceCitation: Ueland T, Akerblom A, Ghukasyan T, Michelsen AE, Aukrust P, Becker RC, Bertilsson M, Himmelmann A, James SK, Siegbahn A, Storey RF, Kontny F, Wallentin L; PLATO (Platelet Inhibition and Patient Outcomes) Trial Investigators. Osteoprotegerin Is Associated With Major Bleeding But Not With Cardiovascular Outcomes in Patients With Acute Coronary Syndromes: Insights From the PLATO (Platelet Inhibition and Patient Outcomes) Trial. J Am Heart Assoc. 2018 Jan 12;7(2):e007009. doi: 10.1161/JAHA.117.007009.

ReferenceCitation: Bellavia A, Wallentin L, Orsini N, James SK, Cannon CP, Himmelmann A, Sundstrom J, Renlund H, Lytsy P. Time-based measures of treatment effect: reassessment of ticagrelor and clopidogrel from the PLATO trial. Open Heart. 2017 Jun 1;4(2):e000557. doi: 10.1136/openhrt-2016-000557. eCollection 2017.

ReferenceCitation: Lindholm D, Hagstrom E, James SK, Becker RC, Cannon CP, Himmelmann A, Katus HA, Maurer G, Lopez-Sendon JL, Steg PG, Storey RF, Siegbahn A, Wallentin L. Growth Differentiation Factor 15 at 1 Month After an Acute Coronary Syndrome Is Associated With Increased Risk of Major Bleeding. J Am Heart Assoc. 2017 Apr 14;6(4):e005580. doi: 10.1161/JAHA.117.005580.

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ReferenceCitation: Lindholm D, James SK, Bertilsson M, Becker RC, Cannon CP, Giannitsis E, Harrington RA, Himmelmann A, Kontny F, Siegbahn A, Steg PG, Storey RF, Velders MA, Weaver WD, Wallentin L; PLATO Investigators. Biomarkers and Coronary Lesions Predict Outcomes after Revascularization in Non-ST-Elevation Acute Coronary Syndrome. Clin Chem. 2017 Feb;63(2):573-584. doi: 10.1373/clinchem.2016.261271. Epub 2016 Dec 8.

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.

ReferenceCitation: Johansson A, Eriksson N, Lindholm D, Varenhorst C, James S, Syvanen AC, Axelsson T, Siegbahn A, Barratt BJ, Becker RC, Himmelmann A, Katus HA, Steg PG, Storey RF, Wallentin L; PLATO Investigators. Genome-wide association and Mendelian randomization study of NT-proBNP in patients with acute coronary syndrome. Hum Mol Genet. 2016 Apr 1;25(7):1447-56. doi: 10.1093/hmg/ddw012. Epub 2016 Jan 21.

ReferenceCitation: Velders MA, Abtan J, Angiolillo DJ, Ardissino D, Harrington RA, Hellkamp A, Himmelmann A, Husted S, Katus HA, Meier B, Schulte PJ, Storey RF, Wallentin L, Gabriel Steg P, James SK; PLATO Investigators. Safety and efficacy of ticagrelor and clopidogrel in primary percutaneous coronary intervention. Heart. 2016 Apr;102(8):617-25. doi: 10.1136/heartjnl-2015-308963. Epub 2016 Feb 4.

ReferenceCitation: Bui AH, Cannon CP, Steg PG, Storey RF, Husted S, Guo J, Im K, James SK, Michelson EL, Himmelmann A, Held C, Varenhorst C, Wallentin L, Scirica BM. Relationship Between Early and Late Nonsustained Ventricular Tachycardia and Cardiovascular Death in Patients With Acute Coronary Syndrome in the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e002951. doi: 10.1161/CIRCEP.115.002951.

ReferenceCitation: Andell P, James SK, Cannon CP, Cyr DD, Himmelmann A, Husted S, Keltai M, Koul S, Santoso A, Steg PG, Storey RF, Wallentin L, Erlinge D; PLATO Investigators. Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes and Chronic Obstructive Pulmonary Disease: An Analysis From the Platelet Inhibition and Patient Outcomes (PLATO) Trial. J Am Heart Assoc. 2015 Oct 9;4(10):e002490. doi: 10.1161/JAHA.115.002490.

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ReferenceCitation: Hagstrom E, James SK, Bertilsson M, Becker RC, Himmelmann A, Husted S, Katus HA, Steg PG, Storey RF, Siegbahn A, Wallentin L; PLATO Investigators. Growth differentiation factor-15 level predicts major bleeding and cardiovascular events in patients with acute coronary syndromes: results from the PLATO study. Eur Heart J. 2016 Apr 21;37(16):1325-33. doi: 10.1093/eurheartj/ehv491. Epub 2015 Sep 28.

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

ReferenceCitation: Kang HJ, Clare RM, Gao R, Held C, Himmelmann A, James SK, Lim ST, Santoso A, Yu CM, Wallentin L, Becker RC; PLATO Investigators. Ticagrelor versus clopidogrel in Asian patients with acute coronary syndrome: A retrospective analysis from the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Am Heart J. 2015 Jun;169(6):899-905.e1. doi: 10.1016/j.ahj.2015.03.015. Epub 2015 Mar 31.

ReferenceCitation: Velders MA, Wallentin L, Becker RC, van Boven AJ, Himmelmann A, Husted S, Katus HA, Lindholm D, Morais J, Siegbahn A, Storey RF, Wernroth L, James SK; PLATO Investigators. Biomarkers for risk stratification of patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention: Insights from the Platelet Inhibition and Patient Outcomes trial. Am Heart J. 2015 Jun;169(6):879-889.e7. doi: 10.1016/j.ahj.2015.02.019. Epub 2015 Mar 5.

ReferenceCitation: Varenhorst C, Eriksson N, Johansson A, Barratt BJ, Hagstrom E, Akerblom A, Syvanen AC, Becker RC, James SK, Katus HA, Husted S, Steg PG, Siegbahn A, Voora D, Teng R, Storey RF, Wallentin L; PLATO Investigators. Effect of genetic variations on ticagrelor plasma levels and clinical outcomes. Eur Heart J. 2015 Aug 1;36(29):1901-12. doi: 10.1093/eurheartj/ehv116. Epub 2015 May 2.

ReferenceCitation: Kholaif N, Zheng Y, Jagasia P, Himmelmann A, James SK, Steg PG, Storey RF, Westerhout CM, Armstrong PW. Baseline Q waves and time from symptom onset to ST-segment elevation myocardial infarction: insights from PLATO on the influence of sex. Am J Med. 2015 Aug;128(8):914.e11-9. doi: 10.1016/j.amjmed.2015.03.005. Epub 2015 Mar 26.

ReferenceCitation: Cowper PA, Pan W, Anstrom KJ, Kaul P, Wallentin L, Davidson-Ray L, Nikolic E, Janzon M, Levin LA, Cannon CP, Harrington RA, Mark DB. Economic analysis of ticagrelor therapy from a U.S. perspective: results from the PLATO study. J Am Coll Cardiol. 2015 Feb 10;65(5):465-76. doi: 10.1016/j.jacc.2014.11.034.

ReferenceCitation: Janzon M, James S, Cannon CP, Storey RF, Mellstrom C, Nicolau JC, Wallentin L, Henriksson M. Health economic analysis of ticagrelor in patients with acute coronary syndromes intended for non-invasive therapy. Heart. 2015 Jan;101(2):119-25. doi: 10.1136/heartjnl-2014-305864. Epub 2014 Sep 16.

ReferenceCitation: Varenhorst C, Alstrom U, Braun OO, Storey RF, Mahaffey KW, Bertilsson M, Cannon CP, Scirica BM, Himmelmann A, James SK, Wallentin L, Held C. Causes of mortality with ticagrelor compared with clopidogrel in acute coronary syndromes. Heart. 2014 Nov;100(22):1762-9. doi: 10.1136/heartjnl-2014-305619. Epub 2014 Jun 23.

ReferenceCitation: Kotsia A, Brilakis ES, Held C, Cannon C, Steg GP, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, James SK. Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2014 Jul;168(1):68-75.e2. doi: 10.1016/j.ahj.2014.04.001. Epub 2014 Apr 13.

ReferenceCitation: Patel MR, Becker RC, Wojdyla DM, Emanuelsson H, Hiatt WR, Horrow J, Husted S, Mahaffey KW, Steg PG, Storey RF, Wallentin L, James SK. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared with clopidogrel: Data from the PLATO Trial. Eur J Prev Cardiol. 2015 Jun;22(6):734-42. doi: 10.1177/2047487314533215. Epub 2014 May 15.

ReferenceCitation: Husted S, James SK, Bach RG, Becker RC, Budaj A, Heras M, Himmelmann A, Horrow J, Katus HA, Lassila R, Morais J, Nicolau JC, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATO study group. The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial. Eur Heart J. 2014 Jun 14;35(23):1541-50. doi: 10.1093/eurheartj/ehu075. Epub 2014 Mar 28.

ReferenceCitation: Mahaffey KW, Held C, Wojdyla DM, James SK, Katus HA, Husted S, Steg PG, Cannon CP, Becker RC, Storey RF, Khurmi NS, Nicolau JC, Yu CM, Ardissino D, Budaj A, Morais J, Montgomery D, Himmelmann A, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. J Am Coll Cardiol. 2014 Apr 22;63(15):1493-9. doi: 10.1016/j.jacc.2014.01.038. Epub 2014 Feb 19.

ReferenceCitation: Wallentin L, Lindholm D, Siegbahn A, Wernroth L, Becker RC, Cannon CP, Cornel JH, Himmelmann A, Giannitsis E, Harrington RA, Held C, Husted S, Katus HA, Mahaffey KW, Steg PG, Storey RF, James SK; PLATO study group. Biomarkers in relation to the effects of ticagrelor in comparison with clopidogrel in non-ST-elevation acute coronary syndrome patients managed with or without in-hospital revascularization: a substudy from the Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2014 Jan 21;129(3):293-303. doi: 10.1161/CIRCULATIONAHA.113.004420. Epub 2013 Oct 29.

ReferenceCitation: Brilakis ES, Held C, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, James SK. Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the PLATelet inhibition and patient outcomes (PLATO) trial. Am Heart J. 2013 Sep;166(3):474-80. doi: 10.1016/j.ahj.2013.06.019. Epub 2013 Jul 26.

ReferenceCitation: Steg PG, Harrington RA, Emanuelsson H, Katus HA, Mahaffey KW, Meier B, Storey RF, Wojdyla DM, Lewis BS, Maurer G, Wallentin L, James SK; PLATO Study Group. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial. Circulation. 2013 Sep 3;128(10):1055-65. doi: 10.1161/CIRCULATIONAHA.113.002589. Epub 2013 Jul 30.

ReferenceCitation: Kunadian V, James SK, Wojdyla DM, Zorkun C, Wu J, Storey RF, Steg PG, Katus H, Emanuelsson H, Horrow J, Maya J, Wallentin L, Harrington RA, Gibson CM. Angiographic outcomes in the PLATO Trial (Platelet Inhibition and Patient Outcomes). JACC Cardiovasc Interv. 2013 Jul;6(7):671-83. doi: 10.1016/j.jcin.2013.03.014.

ReferenceCitation: James SK, Storey RF, Pieper KS, Cannon CP, Becker RC, Steg PG, Wallentin L, Harrington RA; PLATO Study Group. Response to letter regarding article, "Ticagrelor in patients with acute coronary syndromes and stroke: interpretation of subgroups in clinical trials". Stroke. 2013 Aug;44(8):e95-6. doi: 10.1161/STROKEAHA.113.002069. Epub 2013 Jun 25. No abstract available.

ReferenceCitation: James SK, Pieper KS, Cannon CP, Storey RF, Becker RC, Steg PG, Wallentin L, Harrington RA; PLATO study group. Ticagrelor in patients with acute coronary syndromes and stroke: interpretation of subgroups in clinical trials. Stroke. 2013 May;44(5):1477-9. doi: 10.1161/STROKEAHA.111.000514. Epub 2013 Apr 9. No abstract available.

ReferenceCitation: Kohli P, Wallentin L, Reyes E, Horrow J, Husted S, Angiolillo DJ, Ardissino D, Maurer G, Morais J, Nicolau JC, Oto A, Storey RF, James SK, Cannon CP. Reduction in first and recurrent cardiovascular events with ticagrelor compared with clopidogrel in the PLATO Study. Circulation. 2013 Feb 12;127(6):673-80. doi: 10.1161/CIRCULATIONAHA.112.124248. Epub 2012 Dec 31.

ReferenceCitation: Akerblom A, Wallentin L, Siegbahn A, Becker RC, Budaj A, Horrow J, Husted S, Katus H, Claeys MJ, Storey RF, Asenblad N, James SK. Outcome and causes of renal deterioration evaluated by serial cystatin C measurements in acute coronary syndrome patients -- results from the PLATelet inhibition and patient Outcomes (PLATO) study. Am Heart J. 2012 Nov;164(5):728-34. doi: 10.1016/j.ahj.2012.08.017. Epub 2012 Oct 17.

ReferenceCitation: Varenhorst C, Alstrom U, Scirica BM, Hogue CW, Asenblad N, Storey RF, Steg PG, Horrow J, Mahaffey KW, Becker RC, James S, Cannon CP, Brandrup-Wognsen G, Wallentin L, Held C. Factors contributing to the lower mortality with ticagrelor compared with clopidogrel in patients undergoing coronary artery bypass surgery. J Am Coll Cardiol. 2012 Oct 23;60(17):1623-30. doi: 10.1016/j.jacc.2012.07.021. Epub 2012 Sep 26.

ReferenceCitation: Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. doi: 10.1161/CIRCOUTCOMES.111.964395.

ReferenceCitation: Cornel JH, Becker RC, Goodman SG, Husted S, Katus H, Santoso A, Steg G, Storey RF, Vintila M, Sun JL, Horrow J, Wallentin L, Harrington R, James S. Prior smoking status, clinical outcomes, and the comparison of ticagrelor with clopidogrel in acute coronary syndromes-insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2012 Sep;164(3):334-342.e1. doi: 10.1016/j.ahj.2012.06.005. Epub 2012 Jul 26.

ReferenceCitation: Nikolic E, Janzon M, Hauch O, Wallentin L, Henriksson M; PLATO Health Economic Substudy Group. Cost-effectiveness of treating acute coronary syndrome patients with ticagrelor for 12 months: results from the PLATO study. Eur Heart J. 2013 Jan;34(3):220-8. doi: 10.1093/eurheartj/ehs149. Epub 2012 Jun 19.

ReferenceCitation: James SK, Storey RF, Khurmi NS, Husted S, Keltai M, Mahaffey KW, Maya J, Morais J, Lopes RD, Nicolau JC, Pais P, Raev D, Lopez-Sendon JL, Stevens SR, Becker RC; PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes and a history of stroke or transient ischemic attack. Circulation. 2012 Jun 12;125(23):2914-21. doi: 10.1161/CIRCULATIONAHA.111.082727. Epub 2012 May 9.

ReferenceCitation: Siha H, Das D, Fu Y, Zheng Y, Westerhout CM, Storey RF, James S, Wallentin L, Armstrong PW. Baseline Q waves as a prognostic modulator in patients with ST-segment elevation: insights from the PLATO trial. CMAJ. 2012 Jul 10;184(10):1135-42. doi: 10.1503/cmaj.111683. Epub 2012 Apr 30.

ReferenceCitation: Goodman SG, Clare R, Pieper KS, Nicolau JC, Storey RF, Cantor WJ, Mahaffey KW, Angiolillo DJ, Husted S, Cannon CP, James SK, Kilhamn J, Steg PG, Harrington RA, Wallentin L; Platelet Inhibition and Patient Outcomes Trial Investigators. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation. 2012 Feb 28;125(8):978-86. doi: 10.1161/CIRCULATIONAHA.111.032912. Epub 2012 Jan 18.

ReferenceCitation: Armstrong PW, Siha H, Fu Y, Westerhout CM, Steg PG, James SK, Storey RF, Horrow J, Katus H, Clemmensen P, Harrington RA, Wallentin L. ST-elevation acute coronary syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) trial: insights from the ECG substudy. Circulation. 2012 Jan 24;125(3):514-21. doi: 10.1161/CIRCULATIONAHA.111.047530. Epub 2011 Dec 16.

ReferenceCitation: Becker RC, Bassand JP, Budaj A, Wojdyla DM, James SK, Cornel JH, French J, Held C, Horrow J, Husted S, Lopez-Sendon J, Lassila R, Mahaffey KW, Storey RF, Harrington RA, Wallentin L. Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial. Eur Heart J. 2011 Dec;32(23):2933-44. doi: 10.1093/eurheartj/ehr422. Epub 2011 Nov 16. Erratum In: Eur Heart J. 2012 Nov;33(21):2750.

ReferenceCitation: Mahaffey KW, Wojdyla DM, Carroll K, Becker RC, Storey RF, Angiolillo DJ, Held C, Cannon CP, James S, Pieper KS, Horrow J, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2011 Aug 2;124(5):544-54. doi: 10.1161/CIRCULATIONAHA.111.047498. Epub 2011 Jun 27.

ReferenceCitation: James SK, Roe MT, Cannon CP, Cornel JH, Horrow J, Husted S, Katus H, Morais J, Steg PG, Storey RF, Stevens S, Wallentin L, Harrington RA; PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomised PLATelet inhibition and patient Outcomes (PLATO) trial. BMJ. 2011 Jun 17;342:d3527. doi: 10.1136/bmj.d3527.

ReferenceCitation: Scirica BM, Cannon CP, Emanuelsson H, Michelson EL, Harrington RA, Husted S, James S, Katus H, Pais P, Raev D, Spinar J, Steg PG, Storey RF, Wallentin L; PLATO Investigators. The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiographic assessment substudy. J Am Coll Cardiol. 2011 May 10;57(19):1908-16. doi: 10.1016/j.jacc.2010.11.056.

ReferenceCitation: Steg PG, James S, Harrington RA, Ardissino D, Becker RC, Cannon CP, Emanuelsson H, Finkelstein A, Husted S, Katus H, Kilhamn J, Olofsson S, Storey RF, Weaver WD, Wallentin L; PLATO Study Group. Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis. Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8.

ReferenceCitation: James S, Budaj A, Aylward P, Buck KK, Cannon CP, Cornel JH, Harrington RA, Horrow J, Katus H, Keltai M, Lewis BS, Parikh K, Storey RF, Szummer K, Wojdyla D, Wallentin L. Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2010 Sep 14;122(11):1056-67. doi: 10.1161/CIRCULATIONAHA.109.933796. Epub 2010 Aug 30.

ReferenceCitation: Cannon CP, Harrington RA, James S, Ardissino D, Becker RC, Emanuelsson H, Husted S, Katus H, Keltai M, Khurmi NS, Kontny F, Lewis BS, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATelet inhibition and patient Outcomes Investigators. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. Lancet. 2010 Jan 23;375(9711):283-93. doi: 10.1016/S0140-6736(09)62191-7. Epub 2010 Jan 13.

ReferenceCitation: Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

ReferenceCitation: Molecule of the month. Ticagrelor. Drug News Perspect. 2007 May;20(4):264. No abstract available.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Indonesia
India
Romania
Belgium
China
Malaysia
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

summary: The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

status: Completed

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

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

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Imperial College London - Spiral

repository_institution: University of Dundee - Discovery Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_institution: University of Dundee - Discovery Research Portal

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Ireland
Australia
Brazil
Turkey
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Sweden

location_facility: 205.372.01026 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01020 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11006 Clinique de médecine familiale de La Malbaie

location_facility: 205.372.39008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88606 National Cheng Kung University Hospital

location_facility: 205.372.90005 Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: 205.372.52010 Hospital General Agustin O´Haran

location_facility: 205.372.91007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.47002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49016 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01064 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.85203 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52014 Hospital Angeles de las Lomas

location_facility: 205.372.61004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.61009 Thoracic & General Physician

location_facility: 205.372.34002 Hospital Universitario Dr. Peset

location_facility: 205.372.01044 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.55010 Unidade de Coracao e Pulmao do Dto. de Medicina

location_facility: 205.372.44019 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.3302A Centre Médical Erdre Saint Augustin

location_facility: 205.372.91011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01062 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52005 Hospital Civil Nuevo de Guadalajara

location_facility: 205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.

location_facility: 205.372.01045 Boehringer Ingelheim Investigational Site

location_facility: 205.372.47003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.65003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44028 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.35803 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.01036 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia

location_facility: 205.372.82003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52018 Hospital Universitario de Chihuahua

location_facility: 205.372.3303A Hôpital Notre Dame de Bon Secours

location_facility: 205.372.49003 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.82008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11004 Mount Royal Family Physicians

location_facility: 205.372.01049 Boehringer Ingelheim Investigational Site

location_facility: 205.372.45006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44022 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52002 Unidad de Investigación clínica en Medicina

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location_facility: 205.372.44023 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49012 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.49009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.35802 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.3303B Hôpital Notre Dame de Bon Secours

location_facility: 205.372.45001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.37001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52001 Hospital General del Estado de Sonora

location_facility: 205.372.41002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30019 Boehringer Ingelheim Investigational Site

location_facility: 205.372.47001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91016 Boehringer Ingelheim Investigational Site

location_facility: 205.372.61003 Sir Charles Gairdner Hospital

location_facility: 205.372.49007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11007 Heritage Medical Research Building

location_facility: 205.372.42102 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44027 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.

location_facility: 205.372.88605 Chang Gung Memorial Hosp-Linkou

location_facility: 205.372.91003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.41001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01063 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.65005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11018 Pacific Lung Health Centre

location_facility: 205.372.11003 London Road Diagnostic Clinic and Medical Centre

location_facility: 205.372.31011 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.27005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01066 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01067 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.61008 Geelong Clinical Research Centre

location_facility: 205.372.86012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01035 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.86009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01028 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.35303 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01069 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01030 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi

location_facility: 205.372.11013 Calgary West Medical Centre

location_facility: 205.372.11005 Professional Corp. Respirology

location_facility: 205.372.39003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01065 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31012 Boehringer Ingelheim Investigational Site

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location_facility: 205.372.30017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.35801 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.61007 The Burnside War Memorial Hospital

location_facility: 205.372.65001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)

location_facility: 205.372.01021 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01039 Boehringer Ingelheim Investigational Site

location_facility: 205.372.45005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.41003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.37002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01060 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01040 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01050 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.

location_facility: 205.372.11012 West Lincoln Memorial Hospital

location_facility: 205.372.91010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01029 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44016 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.55011 CEDOES - Diagnóstico e Pesquisa

location_facility: 205.372.44013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52016 Hospital General de Mexicali

location_facility: 205.372.60001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.55001 INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: 205.372.86010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.42103 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01031 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01037 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88602 Taipei Veterans General Hospital

location_facility: 205.372.44018 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01052 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88604 Tri-Service General Hospital

location_facility: 205.372.39004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11016 London Road Diagnostic Clinic and Medical Centre

location_facility: 205.372.44006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D

location_facility: 205.372.01046 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01034 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01061 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44020 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01053 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90008 Erciyes Universitesi Tip Fakultesi

location_facility: 205.372.01024 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88608 Boehringer Ingelheim Investigational Site

location_facility: 205.372.55005 Hospital Geral Otávio de Freitas

location_facility: 205.372.30009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88609 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44026 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01023 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49001 Boehringer Ingelheim Investigational Site

location_facility: 205.372.39012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01055 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01013 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88601 National Taiwan University Hospital

location_facility: 205.372.45004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari

location_facility: 205.372.45002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.52012 Hospital de Nuestra Señora de la Salud

location_facility: 205.372.91004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11020 Wetaskiwin Lung Laboratory

location_facility: 205.372.11019 Allergy and Asthma Research Centre

location_facility: 205.372.39007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01011 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11002 Centenary Respiratory Research Associates

location_facility: 205.372.55009 Hospital das Clínicas de Goiânia

location_facility: 205.372.01059 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01056 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44009 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01038 Boehringer Ingelheim Investigational Site

location_facility: 205.372.82010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.55012 Universidade Federal de Santa Catarina

location_facility: 205.372.34005 Hospital San Pedro de Alcántara

location_facility: 205.372.27002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.88607 Kaohsiung Medical University Hospital

location_facility: 205.372.36005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44024 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11017 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01019 Boehringer Ingelheim Investigational Site

location_facility: 205.372.90010 Selcuk Universitesi Tip Fakultesi

location_facility: 205.372.44003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.35804 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01007 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01068 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01022 Boehringer Ingelheim Investigational Site

location_facility: 205.372.31004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.91014 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01048 Boehringer Ingelheim Investigational Site

location_facility: 205.372.27006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.36004 Boehringer Ingelheim Investigational Site

location_facility: 205.372.85201 Boehringer Ingelheim Investigational Site

location_facility: 205.372.60005 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49008 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01043 Boehringer Ingelheim Investigational Site

location_facility: 205.372.30002 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.86006 Boehringer Ingelheim Investigational Site

location_facility: 205.372.44010 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01012 Boehringer Ingelheim Investigational Site

location_facility: 205.372.45003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.61002 Woolcock Institute of Medical Research

location_facility: 205.372.90007 Atatürk Gög. Hastaliklari ve Cerrahisi Egitim Hastanesi

location_facility: 205.372.01041 Boehringer Ingelheim Investigational Site

location_facility: 205.372.11009 White Hills Medical Clinic

location_facility: 205.372.30003 Boehringer Ingelheim Investigational Site

location_facility: 205.372.49015 Boehringer Ingelheim Investigational Site

location_facility: 205.372.01058 Boehringer Ingelheim Investigational Site

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia

acronym: RECORD

summary: This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

study_completion_date_type: Actual

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Komajda M, Curtis P; RECORD Study Group. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med. 2007 Jun;24(6):626-34. doi: 10.1111/j.1464-5491.2007.02160.x.

ReferenceCitation: Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35. doi: 10.1007/s00125-005-1869-1. Epub 2005 Jul 16.

ReferenceCitation: Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007 Jul 5;357(1):28-38. doi: 10.1056/NEJMoa073394. Epub 2007 Jun 5.

ReferenceCitation: Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009 Jun 20;373(9681):2125-35. doi: 10.1016/S0140-6736(09)60953-3. Epub 2009 Jun 6.

ReferenceCitation: Komajda M, Curtis P, Hanefeld M, Beck-Nielsen H, Pocock SJ, Zambanini A, Jones NP, Gomis R, Home PD; RECORD Study Group. Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study). Cardiovasc Diabetol. 2008 Apr 24;7:10. doi: 10.1186/1475-2840-7-10.

ReferenceCitation: Jones NP, Curtis PS, Home PD. Cancer and bone fractures in observational follow-up of the RECORD study. Acta Diabetol. 2015 Jun;52(3):539-46. doi: 10.1007/s00592-014-0691-y. Epub 2014 Dec 19.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer

ReferenceCitation: MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Poland
New Zealand
Australia
Croatia
France
Czech Republic
Lithuania
Slovakia
Hungary
Denmark
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Spain
Greece
Bulgaria
Russian Federation
Sweden

intervention_type: Drug


type: EudraCT Number

title: A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy

acronym: ICELAND

summary: Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.

ReferenceCitation: Tombal B, Cornel EB, Persad R, Stari A, Gomez Veiga F, Schulman C. Clinical Outcomes and Testosterone Levels Following Continuous Androgen Deprivation in Patients with Relapsing or Locally Advanced Prostate Cancer: A Post Hoc Analysis of the ICELAND Study. J Urol. 2017 Nov;198(5):1054-1060. doi: 10.1016/j.juro.2017.05.072. Epub 2017 May 25.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Schulman C, Cornel E, Matveev V, Tammela TL, Schraml J, Bensadoun H, Warnack W, Persad R, Salagierski M, Gomez Veiga F, Baskin-Bey E, Lopez B, Tombal B. Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND). Eur Urol. 2016 Apr;69(4):720-727. doi: 10.1016/j.eururo.2015.10.007. Epub 2015 Oct 29.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Tampere University - Tampere University Institutional Repository

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
Germany
Italy
Slovakia
Hungary
Belgium
Spain
Czech Republic
Russian Federation
France


title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer

summary: This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

ReferenceCitation: P Goss, I Smith, J O'Shaughnessy, B Ejlertsen, M Kaufmann, F Boyle, A Buzdar, P Fumoleau, W Gradishar, M Martin, B Moy, M Piccart-Gebhart, K I Pritchard, D Lindquist, Y Chavarri-Guerra, G Aktan, E Rappold, L S Williams, D M Finkelstein. Resubmission: A Randomized Trial of Adjuvant Lapatinib in Women with Early Stage HER2 Overexpressing Breast Cancer. Lancet Oncol. 2012;S 1470-2045(12):70508-9.

ReferenceCitation: Boyle FM, Smith IE, O'Shaughnessy J, Ejlertsen B, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Amonkar M, Huang Y, Rappold E, Williams LS, Wang-Silvanto J, Kaneko T, Finkelstein DM, Goss PE; TEACH Investigators. Health related quality of life of women in TEACH, a randomised placebo controlled adjuvant trial of lapatinib in early stage Human Epidermal Growth Factor Receptor (HER2) overexpressing breast cancer. Eur J Cancer. 2015 Apr;51(6):685-96. doi: 10.1016/j.ejca.2015.02.005. Epub 2015 Mar 6.

ReferenceCitation: Schaid DJ, Spraggs CF, McDonnell SK, Parham LR, Cox CJ, Ejlertsen B, Finkelstein DM, Rappold E, Curran J, Cardon LR, Goss PE. Prospective validation of HLA-DRB1*07:01 allele carriage as a predictive risk factor for lapatinib-induced liver injury. J Clin Oncol. 2014 Aug 1;32(22):2296-303. doi: 10.1200/JCO.2013.52.9867. Epub 2014 Mar 31.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Goss PE, Smith IE, O'Shaughnessy J, Ejlertsen B, Kaufmann M, Boyle F, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Chavarri-Guerra Y, Aktan G, Rappold E, Williams LS, Finkelstein DM; TEACH investigators. Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Jan;14(1):88-96. doi: 10.1016/S1470-2045(12)70508-9. Epub 2012 Dec 10. Erratum In: Lancet Oncol. 2013 Feb;14(2):e47.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Croatia
Chile
Canada
France
Czech Republic
Lithuania
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Ukraine
India
Belgium
China
Peru
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel


title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)

summary: This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

ReferenceCitation: Simo R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzman J, Dotta F, Festa A, Zhou M, Kiljanski J. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.

repositories_concat: PubMed Central

ReferenceCitation: Schernthaner G, Rosas-Guzman J, Dotta F, Guerci B, Simo R, Festa A, Kiljanski J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8.

publisher_dissemination: Wiley

ReferenceCitation: Gallwitz B, Guzman J, Dotta F, Guerci B, Simo R, Basson BR, Festa A, Kiljanski J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_country:
Finland
Germany
Ireland
Italy
Poland
Hungary
Israel
United Kingdom
Switzerland
Austria
Mexico
Spain
Czech Republic
France


type: Other Identifier

title: Gaucher Disease Registry Protocol

summary:
The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The objectives of the Registry are:

To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
To characterize the Gaucher disease population.
To evaluate the long-term effectiveness of imiglucerase and of eliglustat.

Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: El-Beshlawy A, Tylki-Szymanska A, Vellodi A, Belmatoug N, Grabowski GA, Kolodny EH, Batista JL, Cox GF, Mistry PK. Long-term hematological, visceral, and growth outcomes in children with Gaucher disease type 3 treated with imiglucerase in the International Collaborative Gaucher Group Gaucher Registry. Mol Genet Metab. 2017 Jan-Feb;120(1-2):47-56. doi: 10.1016/j.ymgme.2016.12.001. Epub 2016 Dec 6.

ReferenceCitation: Mistry PK, Batista JL, Andersson HC, Balwani M, Burrow TA, Charrow J, Kaplan P, Khan A, Kishnani PS, Kolodny EH, Rosenbloom B, Scott CR, Weinreb N. Transformation in pretreatment manifestations of Gaucher disease type 1 during two decades of alglucerase/imiglucerase enzyme replacement therapy in the International Collaborative Gaucher Group (ICGG) Gaucher Registry. Am J Hematol. 2017 Sep;92(9):929-939. doi: 10.1002/ajh.24801. Epub 2017 Jul 7.

ReferenceCitation: Weinreb NJ, Goldblatt J, Villalobos J, Charrow J, Cole JA, Kerstenetzky M, vom Dahl S, Hollak C. Long-term clinical outcomes in type 1 Gaucher disease following 10 years of imiglucerase treatment. J Inherit Metab Dis. 2013 May;36(3):543-53. doi: 10.1007/s10545-012-9528-4. Epub 2012 Sep 14. Erratum In: J Inherit Metab Dis. 2014 Jan;37(1):147.

ReferenceCitation: Rosenbloom BE, Cappellini MD, Weinreb NJ, Dragosky M, Revel-Vilk S, Batista JL, Sekulic D, Mistry PK. Cancer risk and gammopathies in 2123 adults with Gaucher disease type 1 in the International Gaucher Group Gaucher Registry. Am J Hematol. 2022 Oct;97(10):1337-1347. doi: 10.1002/ajh.26675. Epub 2022 Aug 24.

ReferenceCitation: Weinreb NJ, Camelo JS Jr, Charrow J, McClain MR, Mistry P, Belmatoug N; International Collaborative Gaucher Group (ICGG) Gaucher Registry (NCT00358943) investigators. Gaucher disease type 1 patients from the ICGG Gaucher Registry sustain initial clinical improvements during twenty years of imiglucerase treatment. Mol Genet Metab. 2021 Feb;132(2):100-111. doi: 10.1016/j.ymgme.2020.12.295. Epub 2021 Jan 8.

oa_host_type: publisher

ReferenceCitation: Weinreb NJ, Kaplan P. The history and accomplishments of the ICGG Gaucher registry. Am J Hematol. 2015 Jul;90 Suppl 1:S2-5. doi: 10.1002/ajh.24054. No abstract available.

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Buyers RP, Collin-Histed T. Foreword. Am J Hematol. 2015 Jul;90 Suppl 1:S1. doi: 10.1002/ajh.24053. No abstract available.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Poland
Taiwan
Argentina
Australia
Brazil
Japan
Kuwait
Thailand
Vietnam
Turkey
Croatia
Pakistan
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Dominican Republic
Indonesia
India
Romania
Lebanon
Belgium
China
Malaysia
Peru
Egypt
Philippines
Italy
United Kingdom
Singapore
Sweden
Netherlands
United Arab Emirates
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Jordan
Bulgaria
Russian Federation
Israel

location_facility: Tower Hematology/Oncology Medical Group-Site Number:840056

location_facility: University of Arkansas for Medical Sciences-Site Number:840113

location_facility: Joseph M. Sanzari Children's Hospital-Site Number:840101

location_facility: University of Virginia School of Medicine-Pediatrics-Site Number:840078

location_facility: Children's Mercy Hospital- Pediatrics-Site Number:840063

location_facility: Baylor Research Center-Site Number:840058

location_facility: Ann and Robert Lurie Children's Hospital-Site Number:840011

location_facility: Indianapolis University School of Medicine-Site Number:840027

location_facility: Loma Linda University Children's Hospital-Site Number:840117

location_facility: Arkansas Childrens Hospital-Site Number:840109

location_facility: Children's Hospital of Orange County-Site Number:840074

location_facility: Oregon Health & Science University-Site Number:840080

location_facility: University of Pittsburgh-Site Number:840023

location_facility: Multicare Health System ¿ Mary Bridge Childrens Hospital-Site Number:840115

location_facility: New York University School Of Medicine-Site Number:840040

location_facility: Tulane University Medical Center-Site Number:840001

location_facility: Ann and Robert Lurie Children's Hospital-Site Number:840013

location_facility: University of Louisville- Genetics-Site Number:840030

location_facility: USC Health Sciences Center Dept of Genetics-Site Number:840082

location_facility: Massachusetts General Hospital-Genetics-Site Number:840062

location_facility: Children's National Medical Center-Site Number:840067

location_facility: University of Nebraska Medical Center- Pediatrics-Site Number:840084

location_facility: Metropolitan Hospital Center-Site Number:840110

location_facility: Seattle Children's Hospital-Site Number:840028

location_facility: Stanford Unviersity MC Dept of Genetics-Site Number:840022

location_facility: University of Arizona-Site Number:840015

location_facility: Duke University Medical Center Genetics Dept-Site Number:840037

location_facility: University Of Miami SOM-Site Number:840006

location_facility: University of California at San Francisco-Site Number:840051

location_facility: Cleveland Clinic Foundation Pediatrics-Site Number:840048

location_facility: Rush University Medical Center Genetics-Site Number:840079

location_facility: Boston Children's Hospital-Site Number:840092

location_facility: New York Medical College-Site Number:840039

location_facility: Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089

location_facility: Cook Children's Health Care System-Site Number:840024

location_facility: University Hematology Oncology-Site Number:840075

location_facility: Nationwide Children's Hospital-Site Number:840091

location_facility: Ochsner Medical Center-Site Number:840120

location_facility: St. Peter's University Hospital-Site Number:840016

location_facility: University of Florida-Genetics-Site Number:840096

location_facility: University of Florida Pediatrics Genetics-Site Number:840121

location_facility: Pediatric Endocrine Associates-Site Number:840017

location_facility: State University of New York-Site Number:840052

location_facility: St. Joseph's Children's Hospital-Site Number:840057

location_facility: Children's Hospital and Clinics of Minnesota-Site Number:840046

location_facility: Phoenix Children's Hospital-Site Number:840003

location_facility: University of California at Irvine-Site Number:840036

location_facility: Children's Hospital of Wisconsin-Pediatrics-Site Number:840054

location_facility: Carolinas Medical Center Hospital-Site Number:840065

location_facility: UC Davis MIND Institute-Site Number:840010

location_facility: Children's Specialty Center of Nevada-Site Number:840008

location_facility: Children's Health Care-Site Number:840114

location_facility: University of California at San Diego-Site Number:840007

location_facility: Children's Hospital of Michigan-Site Number:840066

location_facility: Atlantic Health System-Site Number:840099

location_facility: University of Minnesota Medical Center Pediatrics-Site Number:840076

location_facility: LSD Data Registry Site LLC-Site Number:840094

location_facility: University of Missouri Health System Department of Genetics-Site Number:840031

location_facility: Children's Hospital of the Kings Daughters-Site Number:840072

location_facility: Southern California Permanente Medical Group-Site Number:840108

location_facility: Washington University of St. Louis-Site Number:840100

location_facility: Maine Medical Center Pediatrics-Site Number:840064

location_facility: University of Utah Department of Medical Genetics-Site Number:840043

location_facility: University Of Washington Medical Center-Site Number:840059

location_facility: Rhode Island Hospital Genetics-Site Number:840053

location_facility: Children's Hospital of Philadelphia-Site Number:840034

location_facility: Mt. Sinai School of Medicine-Site Number:840005

location_facility: Kaiser Permanente Hospital-Site Number:840042

location_facility: University of Colorado at Denver Genetics-Site Number:840068

location_facility: University of Rochester Medical Center SOM-Site Number:840105

location_facility: Emory University School of Medicine- Human Genetics-Site Number:840060

location_facility: Vanderbilt University Hospital-Pediatrics-Site Number:840049

location_facility: University of Michigan Pediatrics-Site Number:840107

status_simplified: Ongoing


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia

summary: The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

ReferenceCitation: McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098. Erratum In: Eur J Heart Fail. 2010 Jul;12(7):765. Pouler, A C [corrected to Pouleur, A C].

ReferenceCitation: Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.

ReferenceCitation: Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.

oa_host_type: repository

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

version: submittedVersion

unpaywall_oa_status: green

ReferenceCitation: van der Meer P, Grote Beverborg N, Pfeffer MA, Olson K, Anand IS, Westenbrink BD, McMurray JJV, Swedberg K, Young JB, Solomon SD, van Veldhuisen DJ. Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations. Circ Heart Fail. 2018 Feb;11(2):e004431. doi: 10.1161/CIRCHEARTFAILURE.117.004431.

evidence: open (via free pdf)

lead_sponsor: Amgen

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
India
Romania
Belgium
Estonia
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Bulgaria
Russian Federation
Israel


title: A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

summary: Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

lead_sponsor: Solvay Pharmaceuticals

location_country:
Germany
Poland
Hungary
Denmark
Netherlands
Ukraine
Czech Republic
France

location_facility:
Site 709
Site 016
Site 321
Site 019
Site 310
Site 607
Site 008
Site 017
Site 512
Site 609
Site 606
Site 508
Site 015
Site 509
Site 316
Site 702
Site 610
Site 706
Site 109
Site 005
Site 320
Site 601
Site 115
Site 708
Site 018
Site 712
Site 409
Site 305
Site 410
Site 503
Site 608
Site 403
Site 710
Site 010
Site 303
Site 412
Site 311
Site 006
Site 505
Site 602
Site 406
Site 514
Site 314
Site 301
Site 506
Site 502
Site 312
Site 313
Site 111
Site 317
Site 703
Site 112
Site 102
Site 002
Site 714
Site 507
Site 107
Site 101
Site 001
Site 013
Site 411
Site 203
Site 110
Site 401
Site 306
Site 205
Site 307
Site 501
Site 504
Site 711
Site 413
Site 304
Site 103
Site 404
Site 713
Site 105
Site 308
Site 405
Site 604
Site 715
Site 605
Site 004
Site 315
Site 707
Site 510
Site 011
Site 704
Site 009
Site 302
Site 408
Site 603
Site 104
Site 318
Site 007
Site 309
Site 402
Site 407
Site 705
Site 201
Site 701
Site 511
Site 003
Site 114
Site 106
Site 012
Site 113
Site 319
Site 513
Site 108
Site 014


title: A 54-week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Donepezil on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease.

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

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

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Chile
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
India
Italy
Austria
Mexico
Spain
Greece


title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity

summary: Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

ReferenceCitation: Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jagel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P, Nolan D, Hughes S, Hughes A, Ryan S, Fitch N, Thorborn D, Benbow A; PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008 Feb 7;358(6):568-79. doi: 10.1056/NEJMoa0706135.

location_country:
Germany
Ireland
Poland
Australia
France
Slovenia
Portugal
Switzerland
Latvia
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Russian Federation
Israel


title: Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study

acronym: EOS

summary: The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

ReferenceType: result

ReferenceCitation: Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.

ReferenceCitation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
Spain
South Africa
Canada
France

location_facility: Altana Pharma/Nycomed Investigational Sites


title: A Case-Control Toxicogenomics Study to Identify Unique Genetic Polymorphisms in Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

summary: Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.

time_perspective: Retrospective

location_country:
Germany
United Kingdom
Argentina
Australia
Netherlands
United States
Spain
Thailand
Taiwan
Canada
France

location_facility: 1100.1452.4902 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01012 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44009 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.54004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4916 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4910 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61008 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4903 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4933 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.66002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4904 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88606 China Medical University Hospital

location_facility: 1100.1452.01014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34009 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.31001 Academisch Medisch Centrum

location_facility: 1100.1452.3314A Hôpital Européen Georges Pompidou

location_facility: 1100.1452.44005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.3310A Hôpital Bichat Claude Bernard

location_facility: 1100.1452.44007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88605 Chung-Ho Memorial Hospital, Kaohsiung Medical University

location_facility: 1100.1452.01001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34010 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.66001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.9907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.3310B Hôpital Bichat Claude Bernard

location_facility: 1100.1452.44001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88602 Kaohsiung Veterans General Hospital

location_facility: 1100.1452.01502 Toronto General Hospital

location_facility: 1100.1452.4932 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01016 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.66003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01504 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.54003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4931 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88601 National Taiwan University Hospital

location_facility: 1100.1452.4918 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01015 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4912 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.3303A Hôpital de la Pité Salpêtrière

location_facility: 1100.1452.44008 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.31002 Onze Lieve Vrouwen Gasthuis

location_facility: 1100.1452.01013 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.99999 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01002 Boehringer Ingelheim Investigational Site


title: An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.

summary: This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Zhou L, Meng F, Yin O, Wang J, Wang Y, Wei Y, Hu P, Shen Z. Nilotinib for imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis: a single- and multiple-dose, open-label pharmacokinetic study in Chinese patients. Clin Ther. 2009 Jul;31(7):1568-75. doi: 10.1016/j.clinthera.2009.07.016.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Ireland
Poland
Australia
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Lebanon
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Sweden

location_facility: University of South Alabama Cancer Research Institute

location_facility: Georgetown University Medical Center-Lombardi Cancer Center

location_facility: Osler Medical Inc./Osler Clinical Research

location_facility: University of New Mexico Health Sciences Center

status_simplified: Unknown


title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

summary:
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

ReferenceCitation: Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum In: Lancet. 2010 Oct 2;376(9747):1146.

ReferenceCitation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

ReferenceCitation: Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.

location_country:
Germany
New Zealand
Hungary
United Kingdom
Romania
Australia
Brazil
Austria
United States
Russian Federation
France

location_facility: Altana Pharma/Nycomed Investigational Site