title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

ReferenceCitation: Kahl S, Ofstad AP, Zinman B, Wanner C, Schüler E, Sattar N, Inzucchi SE, Roden M. Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes. Diabetes Obes Metab. 2022 Jun;24(6):1061-1071. doi: 10.1111/dom.14670. Epub 2022 Mar 8.

ReferenceCitation: Ruggenenti P, Kraus BJ, Inzucchi SE, Zinman B, Hantel S, Mattheus M, von Eynatten M, Remuzzi G, Koitka-Weber A, Wanner C. Nephrotic-range proteinuria in type 2 diabetes: Effects of empagliflozin on kidney disease progression and clinical outcomes. EClinicalMedicine. 2021 Dec 24;43:101240. doi: 10.1016/j.eclinm.2021.101240. eCollection 2022 Jan.

ReferenceCitation: Reifsnider OS, Kansal AR, Wanner C, Pfarr E, Koitka-Weber A, Brand SB, Stargardter M, Wang C, Kuti E, Ustyugova A. Cost-Effectiveness of Empagliflozin in Patients With Diabetic Kidney Disease in the United States: Findings Based on the EMPA-REG OUTCOME Trial. Am J Kidney Dis. 2022 Jun;79(6):796-806. doi: 10.1053/j.ajkd.2021.09.014. Epub 2021 Nov 6.

ReferenceCitation: Ferreira JP, Inzucchi SE, Mattheus M, Meinicke T, Steubl D, Wanner C, Zinman B. Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2022 Jan;24(1):135-141. doi: 10.1111/dom.14559. Epub 2021 Oct 4.

ReferenceCitation: Vaduganathan M, Inzucchi SE, Sattar N, Fitchett DH, Ofstad AP, Brueckmann M, George JT, Verma S, Mattheus M, Wanner C, Zinman B, Butler J. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2021 Dec;23(12):2775-2784. doi: 10.1111/dom.14535. Epub 2021 Oct 7.

ReferenceCitation: Sharma A, Ofstad AP, Ahmad T, Zinman B, Zwiener I, Fitchett D, Wanner C, George JT, Hantel S, Desai N, Mentz RJ. Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes: Insights From the EMPA-REG OUTCOME Trial. JACC Heart Fail. 2021 Aug;9(8):568-577. doi: 10.1016/j.jchf.2021.03.003.

ReferenceCitation: Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.

ReferenceCitation: Ferreira JP, Kraus BJ, Zwiener I, Lauer S, Zinman B, Fitchett DH, Koitka-Weber A, George JT, Ofstad AP, Wanner C, Zannad F. Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e020053. doi: 10.1161/JAHA.120.020053. Epub 2021 Mar 23.

ReferenceCitation: Ferreira JP, Verma S, Fitchett D, Ofstad AP, Lauer S, Zwiener I, George J, Wanner C, Zinman B, Inzucchi SE. Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Nov 26;19(1):200. doi: 10.1186/s12933-020-01174-6.

ReferenceCitation: McGuire DK, Zinman B, Inzucchi SE, Wanner C, Fitchett D, Anker SD, Pocock S, Kaspers S, George JT, von Eynatten M, Johansen OE, Jamal W, Mattheus M, Elsasser U, Hantel S, Lund SS. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial. Lancet Diabetes Endocrinol. 2020 Dec;8(12):949-959. doi: 10.1016/S2213-8587(20)30344-2.

ReferenceCitation: Ceriello A, Ofstad AP, Zwiener I, Kaspers S, George J, Nicolucci A. Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Oct 13;19(1):176. doi: 10.1186/s12933-020-01147-9.

ReferenceCitation: Neeland IJ, Eliasson B, Kasai T, Marx N, Zinman B, Inzucchi SE, Wanner C, Zwiener I, Wojeck BS, Yaggi HK, Johansen OE; EMPA-REG OUTCOME Investigators. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2020 Dec;43(12):3007-3015. doi: 10.2337/dc20-1096. Epub 2020 Oct 1.

ReferenceCitation: Levin A, Perkovic V, Wheeler DC, Hantel S, George JT, von Eynatten M, Koitka-Weber A, Wanner C; EMPA-REG OUTCOME Investigators. Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Clin J Am Soc Nephrol. 2020 Oct 7;15(10):1433-1444. doi: 10.2215/CJN.14901219. Epub 2020 Sep 29.

ReferenceCitation: Waijer SW, Xie D, Inzucchi SE, Zinman B, Koitka-Weber A, Mattheus M, von Eynatten M, Inker LA, Wanner C, Heerspink HJL. Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016976. doi: 10.1161/JAHA.120.016976. Epub 2020 Sep 6.

ReferenceCitation: Böhm M, Fitchett D, Ofstad AP, Brueckmann M, Kaspers S, George JT, Zwiener I, Zinman B, Wanner C, Marx N, Mancia G, Anker SD, Mahfoud F. Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME. J Hypertens. 2020 Sep;38(9):1829-1840. doi: 10.1097/HJH.0000000000002492.

ReferenceCitation: Inzucchi SE, Khunti K, Fitchett DH, Wanner C, Mattheus M, George JT, Ofstad AP, Zinman B. Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9). pii: dgaa321. doi: 10.1210/clinem/dgaa321.

ReferenceCitation: Ferreira JP, Fitchett D, Ofstad AP, Kraus BJ, Wanner C, Zwiener I, Zinman B, Lauer S, George JT, Rossignol P, Zannad F. Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. Am J Hypertens. 2020 Dec 31;33(12):1092-1101. doi: 10.1093/ajh/hpaa073.

ReferenceCitation: Perkovic V, Koitka-Weber A, Cooper ME, Schernthaner G, Pfarr E, Woerle HJ, von Eynatten M, Wanner C. Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME® trial. Nephrol Dial Transplant. 2020 Dec 4;35(12):2103-2111. doi: 10.1093/ndt/gfz179.

ReferenceCitation: Kansal A, Reifsnider OS, Proskorovsky I, Zheng Y, Pfarr E, George JT, Kandaswamy P, Ruffolo A. Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial. Diabet Med. 2019 Nov;36(11):1494-1502. doi: 10.1111/dme.14076. Epub 2019 Jul 23.

ReferenceCitation: Butler J, Zannad F, Fitchett D, Zinman B, Koitka-Weber A, von Eynatten M, Zwiener I, George J, Brueckmann M, Cheung AK, Wanner C. Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. Circ Heart Fail. 2019 Jun;12(6):e005875. doi: 10.1161/CIRCHEARTFAILURE.118.005875. Epub 2019 Jun 5.

ReferenceCitation: Verma S, Wanner C, Zwiener I, Ofstad AP, George JT, Fitchett D, Zinman B; EMPA-REG OUTCOME Investigators. Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes. J Am Coll Cardiol. 2019 Jun 4;73(21):2780-2782. doi: 10.1016/j.jacc.2019.03.002. Epub 2019 Mar 15.

ReferenceCitation: Januzzi J, Ferreira JP, Böhm M, Kaul S, Wanner C, Brueckmann M, Petrie MC, Ofstad AP, Zeller C, George J, Fitchett D, Zannad F. Empagliflozin reduces the risk of a broad spectrum of heart failure outcomes regardless of heart failure status at baseline. Eur J Heart Fail. 2019 Mar;21(3):386-388. doi: 10.1002/ejhf.1419. Epub 2019 Feb 14.

ReferenceCitation: Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778.

ReferenceCitation: Verma S, Mazer CD, Fitchett D, Inzucchi SE, Pfarr E, George JT, Zinman B. Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME® randomised trial. Diabetologia. 2018 Aug;61(8):1712-1723. doi: 10.1007/s00125-018-4644-9. Epub 2018 May 19.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Inzucchi SE, Zinman B, Fitchett D, Wanner C, Ferrannini E, Schumacher M, Schmoor C, Ohneberg K, Johansen OE, George JT, Hantel S, Bluhmki E, Lachin JM. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2018 Feb;41(2):356-363. doi: 10.2337/dc17-1096. Epub 2017 Dec 4.

ReferenceCitation: Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, Woerle HJ, Broedl UC, von Eynatten M, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease. Circulation. 2018 Jan 9;137(2):119-129. doi: 10.1161/CIRCULATIONAHA.117.028268. Epub 2017 Sep 13.

ReferenceCitation: Cherney DZI, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, von Eynatten M, Wanner C. Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):610-621. doi: 10.1016/S2213-8587(17)30182-1. Epub 2017 Jun 27.

ReferenceCitation: Zinman B, Inzucchi SE, Lachin JM, Wanner C, Fitchett D, Kohler S, Mattheus M, Woerle HJ, Broedl UC, Johansen OE, Albers GW, Diener HC; EMPA-REG OUTCOME Investigators (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. Stroke. 2017 May;48(5):1218-1225. doi: 10.1161/STROKEAHA.116.015756. Epub 2017 Apr 6.

ReferenceCitation: Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.

ReferenceCitation: Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

ReferenceCitation: Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, Bluhmki E, Hantel S, Kempthorne-Rawson J, Newman J, Johansen OE, Woerle HJ, Broedl UC. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™). Cardiovasc Diabetol. 2014 Jun 19;13:102. doi: 10.1186/1475-2840-13-102.

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summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.


type: EudraCT Number

title: Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial

summary:
RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Ruhstaller T, Thuss-Patience P, Hayoz S, Schacher S, Knorrenschild JR, Schnider A, Plasswilm L, Budach W, Eisterer W, Hawle H, Mariette C, Hess V, Mingrone W, Montemurro M, Girschikofsky M, Schmidt SC, Bitzer M, Bedenne L, Brauchli P, Stahl M; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian 'Arbeitsgemeinschaft Medikamentöse Tumortherapie' (AGMT); Fédération Francophone de Cancérologie Digestive (FFCD)/Fédération de Recherche en Chirurgie (FRENCH). Neoadjuvant chemotherapy followed by chemoradiation and surgery with and without cetuximab in patients with resectable esophageal cancer: a randomized, open-label, phase III trial (SAKK 75/08). Ann Oncol. 2018 Jun 1;29(6):1386-1393. doi: 10.1093/annonc/mdy105.

ReferenceType: derived

ReferenceCitation: von Holzen U, Schmidt S, Hayoz S, Steffen T, Grieder F, Bartsch D, Schnider A, Knoefel WT, Piessen G, Kettelhack C, Marti WR, Schäfer M, Függer R, Köigsrainer A, Gloor B, Furrer M, Gérard MA, Hawle H, Walz MK, Alesina P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK), the German Esophageal Cancer Study Group, the Austrian Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT), the Fédération Francophone de Cancérologie Digestive (FFCD)/Fédération de Recherche en Chirurgie (FRENCH). Surgical Outcomes After Neoadjuvant Chemoradiation Followed by Curative Surgery in Patients With Esophageal Cancer: An Intergroup Phase III Trial of the Swiss Group for Clinical Cancer Research (SAKK 75/08). Ann Surg. 2022 Jun 1;275(6):1130-1136. doi: 10.1097/SLA.0000000000004334. Epub 2020 Aug 26.

ReferenceCitation: Fehr M, Hawle H, Hayoz S, Thuss-Patience P, Schacher S, Riera Knorrenschild J, Dürr D, Knoefel WT, Rumpold H, Bitzer M, Zweifel M, Samaras P, Mey U, Küng M, Winterhalder R, Eisterer W, Hess V, Gérard MA, Templeton A, Stahl M, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT); Fédération Francophone de Cancérologie Digestive (FFCD) / Fédération de Recherche en Chirurgie (FRENCH). High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08. BMC Cancer. 2020 Feb 28;20(1):166. doi: 10.1186/s12885-020-6623-z.

ipd_sharing: No

location_country: Austria Switzerland Hungary France Germany

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Charite University Hospital - Campus Virchow Klinikum

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


acronym: TAO

intervention_type: Drug

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

lead_sponsor: Sanofi

source: euctr

ReferenceType: background

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

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

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

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

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

location_country: Macedonia, The Former Yugoslav Republic of

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summary:
Primary Objective:

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

Secondary Objectives:

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


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

acronym: PISCES

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

ReferenceCitation: Oudard S, Benhamouda N, Escudier B, Ravel P, Tran T, Levionnois E, Negrier S, Barthelemy P, Berdah JF, Gross-Goupil M, Sternberg CN, Bono P, Porta C, De Giorgi U, Parikh O, Hawkins R, Highley M, Wilke J, Decker T, Tanchot C, Gey A, Terme M, Tartour E. Decrease of Pro-Angiogenic Monocytes Predicts Clinical Response to Anti-Angiogenic Treatment in Patients with Metastatic Renal Cell Carcinoma. Cells. 2021 Dec 22;11(1). pii: 17. doi: 10.3390/cells11010017.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
United Kingdom
Italy
Finland
France
Germany


type: Registry Identifier

type: Other Identifier

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

acronym: TRANSIT

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

lead_sponsor: Janssen-Cilag International NV

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