title: ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.

summary:
The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint.

Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.

ReferenceCitation: Böhm M, Schumacher H, Teo KK, Lonn EM, Lauder L, Mancia G, Redon J, Schmieder RE, Sliwa K, Marx N, Weber MA, Williams B, Yusuf S, Mann JFE, Mahfoud F. Cardiovascular outcomes in patients at high cardiovascular risk with previous myocardial infarction or stroke. J Hypertens. 2021 Aug 1;39(8):1602-1610. doi: 10.1097/HJH.0000000000002822.

family: Böhm

full_name: Michael Böhm

given: Michael

family: Schumacher

full_name: Helmut Schumacher

given: Helmut

family: Teo

full_name: Koon K. Teo

given: Koon K.

family: Lonn

full_name: Eva M. Lonn

given: Eva M.

family: Lauder

full_name: Lucas Lauder

given: Lucas

family: Mancia

full_name: Giuseppe Mancia

given: Giuseppe

family: Redon

full_name: Josep Redon

given: Josep

family: Schmieder

full_name: Roland E. Schmieder

given: Roland E.

family: Sliwa

full_name: Karen Sliwa

given: Karen

family: Marx

full_name: Nikolaus Marx

given: Nikolaus

family: Weber

full_name: Michael A. Weber

given: Michael A.

family: Williams

full_name: Bryan Williams

given: Bryan

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Mann

full_name: Johannes F.E. Mann

given: Johannes F.E.

family: Mahfoud

full_name: Felix Mahfoud

given: Felix

title: Cardiovascular outcomes in patients at high cardiovascular risk with previous myocardial infarction or stroke

ReferenceCitation: Böhm M, Schumacher H, Teo KK, Lonn EM, Mahfoud F, Emrich I, Mancia G, Redon J, Schmieder RE, Sliwa K, Lehrke M, Marx N, Weber MA, Williams B, Yusuf S, Mann JFE. Renal outcomes and blood pressure patterns in diabetic and nondiabetic individuals at high cardiovascular risk. J Hypertens. 2021 Apr 1;39(4):766-774. doi: 10.1097/HJH.0000000000002697.

family: Emrich

full_name: Insa Emrich

given: Insa

title: Renal outcomes and blood pressure patterns in diabetic and nondiabetic individuals at high cardiovascular risk

ReferenceCitation: Mancia G, Schumacher H, Böhm M, Mann JFE, Redon J, Facchetti R, Schmieder RE, Lonn EM, Teo KK, Yusuf S. Visit-to-visit blood pressure variability and renal outcomes: results from ONTARGET and TRANSCEND trials. J Hypertens. 2020 Oct;38(10):2050-2058. doi: 10.1097/HJH.0000000000002567.

title: Visit-to-visit blood pressure variability and renal outcomes: results from ONTARGET and TRANSCEND trials

ReferenceCitation: Dehghan M, Mente A, Rangarajan S, Mohan V, Lear S, Swaminathan S, Wielgosz A, Seron P, Avezum A, Lopez-Jaramillo P, Turbide G, Chifamba J, AlHabib KF, Mohammadifard N, Szuba A, Khatib R, Altuntas Y, Liu X, Iqbal R, Rosengren A, Yusuf R, Smuts M, Yusufali A, Li N, Diaz R, Yusoff K, Kaur M, Soman B, Ismail N, Gupta R, Dans A, Sheridan P, Teo K, Anand SS, Yusuf S. Association of egg intake with blood lipids, cardiovascular disease, and mortality in 177,000 people in 50 countries. Am J Clin Nutr. 2020 Apr 1;111(4):795-803. doi: 10.1093/ajcn/nqz348.

name: Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada

name: Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

name: Dr. Mohan's Diabetes Specialities Centre, Gopalapuram, Chennai, India

name: Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada

name: Division of Nutrition, St John's Research Institute, Koramangala, Bangalore, India

name: Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada

name: Faculty of Medicine, University of La Frontera, Temuco, Chile

name: Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil

name: FOSCAL, Medical School, University of Santander, Bucaramanga, Colombia

name: Heart and Lung Institute, Laval University, Quebec City, QC, Canada

name: University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

name: Department of Cardiac Sciences, King Fahad Cardiac Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia

name: Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

name: Division of Angiology, Wroclaw Medical University, Wroclaw, Poland

name: Department of Internal Medicine, 4th Military Hospital in Wroclaw, Wroclaw, Poland

name: Institute for Community and Public Health, Birzeit University, Birzeit, Palestine

name: Advocate Research Institute, Advocate Health Care, Chicago, IL, USA

name: Clinic of Endocrinology and Metabolism Sisli, Istanbul Sisli Hamidiye Etfal Health Training and Research Hospital, Faculty of Medicine, University of Health Sciences, Istanbul, Turkey

name: State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences, Beijing, China

name: Department of Community Health Sciences and Medicine, Aga Khan University, Karachi, Pakistan

name: Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, and Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden

name: School of Life Sciences, Independent University, Dhaka, Bangladesh

name: Centre of Excellence for Nutrition, North-West University, Potchefstroom, South Africa

name: Hatta Hospital, Dubai Medical University, Dubai Health Authority, Dubai, UAE

name: Qingshan Lake Community Health Service Center, Nanchang City, China

name: Clinical Studies Latin America, Rosario, Santa Fe, Argentina

name: Department of Medicine, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia

name: Department of Medicine, UCSI University, Cheras, Selangor, Malaysia

name: Post Graduate Institute of Medical Education and Research, School of Public Health, Chandigarh, India

name: Health Action by People, Thiruvananthapuram, India

name: Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, India

name: Department of Community Health, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia

name: Eternal Heart Care Centre & Research Institute, Jaipur, India

name: Department of Medicine, University of the Philippines, Manila, Philippines

journal_name: The American Journal of Clinical Nutrition

repository_institution: North-west University - Boloka Institutional Repository

repositories_institution: North-west University - Boloka Institutional Repository

title: Association of egg intake with blood lipids, cardiovascular disease, and mortality in 177,000 people in 50 countries

ReferenceCitation: Böhm M, Schumacher H, Teo KK, Lonn EM, Mahfoud F, Mann JFE, Mancia G, Redon J, Schmieder RE, Marx N, Sliwa K, Weber MA, Williams B, Yusuf S. Cardiovascular outcomes and achieved blood pressure in patients with and without diabetes at high cardiovascular risk. Eur Heart J. 2019 Jul 1;40(25):2032-2043. doi: 10.1093/eurheartj/ehz149.

name: Klinik für Innere Medizin III, Saarland University Medical Center, Kirrberger Str. 1, Homburg/Saar, Germany

name: Statistical Consultant, Ingelheim, Germany

name: KfH Kidney Centre, Menzinger Str. 44, München, Germany and Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, Schlossplatz 4, Erlangen, Germany

name: University of Milano-Bicocca, Istituto Clinico Universitario Policlinico di Monza, Piazza dell'Ateneo Nuovo, 1, Milano, Italy

name: Hypertension Unit, Hospital CIínico Universitario, University of Valencia, Av. de Blasco Ibáñez, 13, València, Spain

name: Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, Erlangen, Nuremberg, Germany

name: Department of Internal Medicine, University Hospital RWTH Aachen, Pauwelsstraße 30, Aachen, Germany

name: Faculty of Health Sciences, Hatter Institute for Cardiovascular Research in Africa & IIDMM, University of Cape Town, Cape Town, South Africa

name: Downstate College of Medicine, State University of New York, 450 Clarkson Ave, Brooklyn, NY, USA

name: University College London (UCL), Institute of Cardiovascular Science, National Institute for Health Research (NIHR), UCL Hospitals Biomedical Research Centre, 149 Tottenham Court Road, London, UK

title: Cardiovascular outcomes and achieved blood pressure in patients with and without diabetes at high cardiovascular risk

ReferenceCitation: Böhm M, Schumacher H, Teo KK, Lonn EM, Mahfoud F, Ukena C, Mann JFE, Mancia G, Redon J, Schmieder RE, Sliwa K, Marx N, Weber MA, Williams B, Yusuf S. Resting heart rate and cardiovascular outcomes in diabetic and non-diabetic individuals at high cardiovascular risk analysis from the ONTARGET/TRANSCEND trials. Eur Heart J. 2020 Jan 7;41(2):231-238. doi: 10.1093/eurheartj/ehy808.

name: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, 66421 Homburg/Saar, Germany

name: Statistical Consultant, 55218 Ingelheim, Germany

name: Population Health Research Institute, McMaster University, Hamilton, Ontario L8L 2X2, Canada

name: KfH Kidney Centre, Menzinger Str. 44, 80638 München, Germany

name: Department of Nephrology and Hypertension, University Hospital, Friedrich-Alexander University, Schlossplatz 4, 91054 Erlangen/Nuremberg, Germany

name: University of Milano-Bicocca, Istituto Clinico Universitario Policlinico di Monza, Piazza dell'Ateneo Nuovo, 1, 20126 Milano, Italy

name: Hypertension Unit, Hospital CIínico Universitario, University of Valencia, Av. de Blasco Ibáñez, 13, 46010 València, Spain

name: Faculty of Health Sciences, Hatter Institute for Cardiovascular Research in Africa & IIDMM, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa

name: Department of Internal Medicine, University Hospital RWTH Aachen, Pauwelsstraße 30, 52074 Aachen

name: Downstate College of Medicine, State University of New York, 450 Clarkson Ave, Brooklyn, NY 11203, USA

name: University College London (UCL), Institute of Cardiovascular Science, National Institute for Health Research (NIHR), UCL Hospitals Biomedical Research Centre, 149 Tottenham Court Road, London W1T 7D, UK

ReferenceCitation: Böhm M, Schumacher H, Teo KK, Lonn EM, Mahfoud F, Mann JFE, Mancia G, Redon J, Schmieder RE, Sliwa K, Weber MA, Williams B, Yusuf S. Achieved blood pressure and cardiovascular outcomes in high-risk patients: results from ONTARGET and TRANSCEND trials. Lancet. 2017 Jun 3;389(10085):2226-2237. doi: 10.1016/S0140-6736(17)30754-7. Epub 2017 Apr 5.

title: Achieved blood pressure and cardiovascular outcomes in high-risk patients: results from ONTARGET and TRANSCEND trials

ReferenceCitation: Dunkler D, Kohl M, Teo KK, Heinze G, Dehghan M, Clase CM, Gao P, Yusuf S, Mann JF, Oberbauer R. Dietary risk factors for incidence or progression of chronic kidney disease in individuals with type 2 diabetes in the European Union. Nephrol Dial Transplant. 2015 Aug;30 Suppl 4:iv76-85. doi: 10.1093/ndt/gfv086.

name: Section for Clinical Biometrics, Medical University of Vienna, Center for Medical Statistics, Informatics and Intelligent Systems, Vienna, Austria

name: Department of Nephrology, University of Erlangen-Nürnberg, Erlangen, Germany

name: Population Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, ON, Canada

name: Department of Medicine, McMaster University, Hamilton, ON, Canada

name: Schwabing General Hospital, and KfH Kidney Center, Munich, Germany

name: Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

title: Dietary risk factors for incidence or progression of chronic kidney disease in individuals with type 2 diabetes in the European Union

ReferenceCitation: Böhm M, Schumacher H, Leong D, Mancia G, Unger T, Schmieder R, Custodis F, Diener HC, Laufs U, Lonn E, Sliwa K, Teo K, Fagard R, Redon J, Sleight P, Anderson C, O'Donnell M, Yusuf S. Systolic blood pressure variation and mean heart rate is associated with cognitive dysfunction in patients with high cardiovascular risk. Hypertension. 2015 Mar;65(3):651-61. doi: 10.1161/HYPERTENSIONAHA.114.04568. Epub 2015 Jan 12.

name: From the Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg, Germany (M.B., F.C., U.L.); Boehringer Ingelheim, Pharma GmbH & Co. KG, Ingelheim, Germany (H.S.); Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada (D.L., E.L., K.T., S.Y.); Centro di Fisiologica Clinica e Ipertensione, Universita Milano-Bicocca, Istituto Auxologico, Milan, Italy (G.M.); CARIM-School for Cardiovascular Diseases, Maastricht University, Maastricht, The...

title: Systolic Blood Pressure Variation and Mean Heart Rate Is Associated With Cognitive Dysfunction in Patients With High Cardiovascular Risk

ReferenceCitation: Verdecchia P, Reboldi G, Angeli F, Trimarco B, Mancia G, Pogue J, Gao P, Sleight P, Teo K, Yusuf S. Systolic and diastolic blood pressure changes in relation with myocardial infarction and stroke in patients with coronary artery disease. Hypertension. 2015 Jan;65(1):108-14. doi: 10.1161/HYPERTENSIONAHA.114.04310. Epub 2014 Oct 20.

name: From the Department of Medicine, Hospital of Assisi, Assisi, Italy (P.V.); Department of Medicine (G.R.) and Department of Cardiology and Cardiovascular Pathophysiology (F.A.), University Hospital of Perugia, Perugia, Italy; Department of Clinical Medicine and Cardiovascular and Immunological Sciences, University ‘Federico II’, Naples, Italy (B.T.); Department of Health Sciences, University of Milano-Bicocca and IRCCS Istituto Auxologico Italiano, Milano, Italy (G.M.); Department of Clinical...

title: Systolic and Diastolic Blood Pressure Changes in Relation With Myocardial Infarction and Stroke in Patients With Coronary Artery Disease

ReferenceCitation: Lonn EM, Rambihar S, Gao P, Custodis FF, Sliwa K, Teo KK, Yusuf S, Böhm M. Heart rate is associated with increased risk of major cardiovascular events, cardiovascular and all-cause death in patients with stable chronic cardiovascular disease: an analysis of ONTARGET/TRANSCEND. Clin Res Cardiol. 2014 Feb;103(2):149-59. doi: 10.1007/s00392-013-0644-4. Epub 2013 Dec 20.

ReferenceCitation: Heerspink HJ, Gao P, de Zeeuw D, Clase C, Dagenais GR, Sleight P, Lonn E, Teo KT, Yusuf S, Mann JF. The effect of ramipril and telmisartan on serum potassium and its association with cardiovascular and renal events: results from the ONTARGET trial. Eur J Prev Cardiol. 2014 Mar;21(3):299-309. doi: 10.1177/2047487313510678. Epub 2013 Nov 4.

name: Department of Clinical Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

name: Population Health Research Institute, McMaster University, Canada

name: Department of Cardiology and Pneumologie, University of Montreal, Montreal, Quebec, Canada

name: Munich General Hospitals, Munich and Friedrich Alexander University, Germany

journal_name: European Journal of Preventive Cardiology

title: The effect of ramipril and telmisartan on serum potassium and its association with cardiovascular and renal events: Results from the ONTARGET trial

ReferenceCitation: Dunkler D, Dehghan M, Teo KK, Heinze G, Gao P, Kohl M, Clase CM, Mann JF, Yusuf S, Oberbauer R; ONTARGET Investigators. Diet and kidney disease in high-risk individuals with type 2 diabetes mellitus. JAMA Intern Med. 2013 Oct 14;173(18):1682-92.

ReferenceCitation: Böhm M, Schumacher H, Laufs U, Sleight P, Schmieder R, Unger T, Teo K, Yusuf S. Effects of nonpersistence with medication on outcomes in high-risk patients with cardiovascular disease. Am Heart J. 2013 Aug;166(2):306-314.e7. doi: 10.1016/j.ahj.2013.04.016. Epub 2013 Jun 24.

title: Effects of nonpersistence with medication on outcomes in high-risk patients with cardiovascular disease

ReferenceCitation: Dehghan M, Mente A, Teo KK, Gao P, Sleight P, Dagenais G, Avezum A, Probstfield JL, Dans T, Yusuf S; Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial (ONTARGET)/Telmisartan Randomized Assessment Study in ACEI Intolerant Subjects With Cardiovascular Disease (TRANSCEND) Trial Investigators. Relationship between healthy diet and risk of cardiovascular disease among patients on drug therapies for secondary prevention: a prospective cohort study of 31 546 high-risk individuals from 40 countries. Circulation. 2012 Dec 4;126(23):2705-12. doi: 10.1161/CIRCULATIONAHA.112.103234.

name: From the Population Health Research Institute (M.D., A.M., K.K.T., P.G., S.Y.) and Department of Clinical Epidemiology and Biostatistics (A.M.), McMaster University, Hamilton, ON, Canada; Nuffield Department of Medicine, John Radcliffe Hospital, Oxford, UK (P.S.); Laval University Heart and Lung Institute, Quebec, QC, Canada (G.D.); Research Division, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (A.A.); University of Washington, School of Medicine, Seattle (J.L.P.); and Section of...

title: Relationship Between Healthy Diet and Risk of Cardiovascular Disease Among Patients on Drug Therapies for Secondary Prevention

ReferenceCitation: Barzilay JI, Gao P, Clase CM, Mente A, Mann JF, Sleight P, Yusuf S, Teo KK; OnTARGET/TRANSCEND Investigators. Albuminuria and rapid loss of GFR and risk of new hip and pelvic fractures. Clin J Am Soc Nephrol. 2013 Feb;8(2):233-40. doi: 10.2215/CJN.06640712. Epub 2012 Nov 26.

name: on behalf of the OnTARGET/TRANSCEND Investigators

journal_name: Clinical Journal of the American Society of Nephrology

title: Albuminuria and Rapid Loss of GFR and Risk of New Hip and Pelvic Fractures

ReferenceCitation: Kappert K, Böhm M, Schmieder R, Schumacher H, Teo K, Yusuf S, Sleight P, Unger T; ONTARGET/TRANSCEND Investigators. Impact of sex on cardiovascular outcome in patients at high cardiovascular risk: analysis of the Telmisartan Randomized Assessment Study in ACE-Intolerant Subjects With Cardiovascular Disease (TRANSCEND) and the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial (ONTARGET). Circulation. 2012 Aug 21;126(8):934-41. doi: 10.1161/CIRCULATIONAHA.111.086660. Epub 2012 Jul 24.

name: From the Center for Cardiovascular Research/CCC, and Institute of Laboratory Medicine, Clinical Chemistry and Pathobiochemistry, Charité–University Medicine Berlin, Berlin, Germany (K.K.); CARIM–School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands (T.U.); Klinik für Innere Medizin III, University Clinic of the Saarland, Homburg/Saar, Germany (M.B.); Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany (R.S.); Boehringer...

title: Impact of Sex on Cardiovascular Outcome in Patients at High Cardiovascular Risk

ReferenceCitation: Neumann I, Grassi B. [Critically appraised article]. Rev Med Chil. 2012 Jan;140(1):117-20. doi: /S0034-98872012000100018. Epub 2012 Apr 12. Spanish.

ReferenceCitation: Verdecchia P, Dagenais G, Healey J, Gao P, Dans AL, Chazova I, Binbrek AS, Iacobellis G, Ferreira R, Holwerda N, Karatzas N, Keltai M, Mancia G, Sleight P, Teo K, Yusuf S; Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint TrialTelmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease Investigators. Blood pressure and other determinants of new-onset atrial fibrillation in patients at high cardiovascular risk in the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease studies. J Hypertens. 2012 May;30(5):1004-14. doi: 10.1097/HJH.0b013e3283522a51.

ReferenceCitation: Redon J, Mancia G, Sleight P, Schumacher H, Gao P, Pogue J, Fagard R, Verdecchia P, Weber M, Böhm M, Williams B, Yusoff K, Teo K, Yusuf S; ONTARGET Investigators. Safety and efficacy of low blood pressures among patients with diabetes: subgroup analyses from the ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial). J Am Coll Cardiol. 2012 Jan 3;59(1):74-83. doi: 10.1016/j.jacc.2011.09.040.

title: Safety and Efficacy of Low Blood Pressures Among Patients With Diabetes

ReferenceCitation: Mancia G, Schumacher H, Redon J, Verdecchia P, Schmieder R, Jennings G, Yusoff K, Ryden L, Liu GL, Teo K, Sleight P, Yusuf S. Blood pressure targets recommended by guidelines and incidence of cardiovascular and renal events in the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial (ONTARGET). Circulation. 2011 Oct 18;124(16):1727-36. doi: 10.1161/CIRCULATIONAHA.110.008870. Epub 2011 Sep 26.

name: From the Università Milano-Bicocca, Ospedale San Gerardo, Monza, Milano, Italy (G.M.); Boehringer-Ingelheim, Ingelheim, Germany (H.S.); Carlos III, Hospital Clinico Universitario, Valencia, Spain (J.R.); Struttura Complessa di Medicina, Ospedale di Assisi, Assisi (PG), Italy (P.V.); Nephrologie und Hypertensiologie, Universitätsklinikum Erlangen, Erlangen, Germany (R.S.); Baker IDI Heart and Diabetes Institute, Melbourne, Australia (G.J.); Universiti Teknologi Mara, Selangor, Malaysia (K.Y.);...

title: Blood Pressure Targets Recommended by Guidelines and Incidence of Cardiovascular and Renal Events in the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial (ONTARGET)

ReferenceCitation: Barzilay JI, Gao P, Rydén L, Schumacher H, Probstfield J, Commerford P, Dans A, Ferreira R, Keltai M, Paolasso E, Yusuf S, Teo K; TRANSCEND Investigators. Effects of telmisartan on glucose levels in people at high risk for cardiovascular disease but free from diabetes: the TRANSCEND study. Diabetes Care. 2011 Sep;34(9):1902-7. doi: 10.2337/dc11-0545. Epub 2011 Jul 25.

name: on behalf of the TRANSCEND Investigators

title: Effects of Telmisartan on Glucose Levels in People at High Risk for Cardiovascular Disease but Free From Diabetes

ReferenceCitation: Tobe SW, Clase CM, Gao P, McQueen M, Grosshennig A, Wang X, Teo KK, Yusuf S, Mann JF; ONTARGET and TRANSCEND Investigators. Cardiovascular and renal outcomes with telmisartan, ramipril, or both in people at high renal risk: results from the ONTARGET and TRANSCEND studies. Circulation. 2011 Mar 15;123(10):1098-107. doi: 10.1161/CIRCULATIONAHA.110.964171. Epub 2011 Feb 28.

name: From the Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (S.W.T.); Departments of Medicine and Clinical Epidemiology and Biostatistics (C.M.C.), Population Health Research Institute (P.G., M.M., K.K.T., S.Y.), and Department of Pathology and Molecular Medicine (M.M.), McMaster University, Hamilton, Ontario, Canada; Schwabing General Hospital and KfH Kidney Center, Munich, and Department of Medicine, Friedrich...

title: Cardiovascular and Renal Outcomes With Telmisartan, Ramipril, or Both in People at High Renal Risk

ReferenceCitation: Barzilay JI, Gao P, O'Donnell M, Mann JF, Anderson C, Fagard R, Probstfield J, Dagenais GR, Teo K, Yusuf S; ONTARGET and TRANSCEND Investigators. Albuminuria and decline in cognitive function: The ONTARGET/TRANSCEND studies. Arch Intern Med. 2011 Jan 24;171(2):142-50. doi: 10.1001/archinternmed.2010.502.

title: Albuminuria and Decline in Cognitive Function<subtitle>The ONTARGET/TRANSCEND Studies</subtitle><alt-title>Albuminuria and Decline in Cognitive Function</alt-title>

ReferenceCitation: Dans AL, Teo K, Gao P, Chen JH, Jae-Hyung K, Yusoff K, Chaithiraphan S, Zhu J, Lisheng L, Yusuf S; Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial Investigators. In a subgroup of high-risk Asians, telmisartan was non-inferior to ramipril and better tolerated in the prevention of cardiovascular events. PLoS One. 2010 Dec 21;5(12):e13694. doi: 10.1371/journal.pone.0013694.

title: In a Subgroup of High-Risk Asians, Telmisartan Was Non-Inferior to Ramipril and Better Tolerated in the Prevention of Cardiovascular Events

ReferenceCitation: Anderson C, Teo K, Gao P, Arima H, Dans A, Unger T, Commerford P, Dyal L, Schumacher H, Pogue J, Paolasso E, Holwerda N, Chazova I, Binbrek A, Young J, Yusuf S; ONTARGET and TRANSCEND Investigators. Renin-angiotensin system blockade and cognitive function in patients at high risk of cardiovascular disease: analysis of data from the ONTARGET and TRANSCEND studies. Lancet Neurol. 2011 Jan;10(1):43-53. doi: 10.1016/S1474-4422(10)70250-7. Epub 2010 Oct 25.

ReferenceCitation: Böhm M, Baumhäkel M, Teo K, Sleight P, Probstfield J, Gao P, Mann JF, Diaz R, Dagenais GR, Jennings GL, Liu L, Jansky P, Yusuf S; ONTARGET/TRANSCEND Erectile Dysfunction Substudy Investigators. Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials. Circulation. 2010 Mar 30;121(12):1439-46. doi: 10.1161/CIRCULATIONAHA.109.864199. Epub 2010 Mar 15.

name: From the Department of Cardiology, University of the Saarland (M. Böhm, M. Baumhäkel), Saarbrücken, Germany; Population Health Research Institute (KT, P.G., S.Y.), McMaster University/Hamilton Health Sciences, Hamilton, Ontario, Canada; University of Oxford (P.S.), Oxford, United Kingdom; University of Washington, School of Medicine (J.P.), Seattle, Wash; Department of Nephrology, Hypertension and Rheumatology, Schwabing General Hospital (J.F.M.), Munich, Germany; Department of Cardiology,...

title: Erectile Dysfunction Predicts Cardiovascular Events in High-Risk Patients Receiving Telmisartan, Ramipril, or Both

ReferenceCitation: Verdecchia P, Sleight P, Mancia G, Fagard R, Trimarco B, Schmieder RE, Kim JH, Jennings G, Jansky P, Chen JH, Liu L, Gao P, Probstfield J, Teo K, Yusuf S; ONTARGET/TRANSCEND Investigators. Effects of telmisartan, ramipril, and their combination on left ventricular hypertrophy in individuals at high vascular risk in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease. Circulation. 2009 Oct 6;120(14):1380-9. doi: 10.1161/CIRCULATIONAHA.109.865774. Epub 2009 Sep 21.

name: From the Hospital S. Maria della Misericordia, Clinical Research Unit Preventive Cardiology, Perugia, Italy (P.V.); Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada (P.V., P.G., K.T., S.Y.); Cardiovascular Medicine, John Radcliffe Hospital, Oxford, UK (P.S.); University of Milano-Bicocca, Milano, Italy (G.M.); Hypertension Unit, Catholic University of Leuven, Leuven, Belgium (R.F.); Department of Clinical Medicine and Cardiovascular and Immunological Sciences,...

title: Effects of Telmisartan, Ramipril, and Their Combination on Left Ventricular Hypertrophy in Individuals at High Vascular Risk in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease

ReferenceCitation: Sleight P, Redon J, Verdecchia P, Mancia G, Gao P, Fagard R, Schumacher H, Weber M, Böhm M, Williams B, Pogue J, Koon T, Yusuf S; ONTARGET investigators. Prognostic value of blood pressure in patients with high vascular risk in the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial study. J Hypertens. 2009 Jul;27(7):1360-9. doi: 10.1097/HJH.0b013e32832d7370.

ReferenceCitation: Mann JF, Schmieder RE, Dyal L, McQueen MJ, Schumacher H, Pogue J, Wang X, Probstfield JL, Avezum A, Cardona-Munoz E, Dagenais GR, Diaz R, Fodor G, Maillon JM, Rydén L, Yu CM, Teo KK, Yusuf S; TRANSCEND (Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease) Investigators. Effect of telmisartan on renal outcomes: a randomized trial. Ann Intern Med. 2009 Jul 7;151(1):1-10, W1-2. Epub 2009 May 18.

ReferenceCitation: Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators, Yusuf S, Teo K, Anderson C, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008 Sep 27;372(9644):1174-83. doi: 10.1016/S0140-6736(08)61242-8. Epub 2008 Aug 29. Erratum in: Lancet. 2008 Oct 18;372(9647):1384.

ReferenceCitation: Mann JF, Schmieder RE, McQueen M, Dyal L, Schumacher H, Pogue J, Wang X, Maggioni A, Budaj A, Chaithiraphan S, Dickstein K, Keltai M, Metsärinne K, Oto A, Parkhomenko A, Piegas LS, Svendsen TL, Teo KK, Yusuf S; ONTARGET investigators. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. Lancet. 2008 Aug 16;372(9638):547-53. doi: 10.1016/S0140-6736(08)61236-2.

ReferenceCitation: ONTARGET Investigators, Yusuf S, Teo KK, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P, Anderson C. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008 Apr 10;358(15):1547-59. doi: 10.1056/NEJMoa0801317. Epub 2008 Mar 31.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repositories_institution: University of Debrecen - University of Debrecen Electronic Archive

title: Telmisartan, Ramipril, or Both in Patients at High Risk for Vascular Events

ReferenceCitation: Held C, Gerstein HC, Yusuf S, Zhao F, Hilbrich L, Anderson C, Sleight P, Teo K; ONTARGET/TRANSCEND Investigators. Glucose levels predict hospitalization for congestive heart failure in patients at high cardiovascular risk. Circulation. 2007 Mar 20;115(11):1371-5. Epub 2007 Mar 5.

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location_facility: 502.373.0012 Hopital Laval - Institute Cardiologie de Quebec

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location_facility: 502.373.1654 Göztepe SSK Egitim ve Arastirma Hastanesi

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title: An International, Cross Sectional, Non-interventional, Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

acronym: SYMNET

summary: The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ruszniewski P, Valle JW, Lombard-Bohas C, Cuthbertson DJ, Perros P, Holubec L, Delle Fave G, Smith D, Niccoli P, Maisonobe P, Atlan P, Caplin ME; SYMNET study group. Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study. Dig Liver Dis. 2016 May;48(5):552-558. doi: 10.1016/j.dld.2015.12.013. Epub 2016 Jan 15.

family: Ruszniewski

full_name: Philippe Ruszniewski

given: Philippe

sequence: first

family: Valle

full_name: Juan W. Valle

given: Juan W.

sequence: additional

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: Cuthbertson

full_name: Daniel J. Cuthbertson

given: Daniel J.

family: Perros

full_name: Petros Perros

given: Petros

family: Holubec

full_name: Luboš Holubec

given: Luboš

family: Delle Fave

full_name: Gianfranco Delle Fave

given: Gianfranco

family: Smith

full_name: Denis Smith

given: Denis

family: Niccoli

full_name: Patricia Niccoli

given: Patricia

family: Maisonobe

full_name: Pascal Maisonobe

given: Pascal

family: Atlan

full_name: Philippe Atlan

family: Caplin

full_name: Martyn E. Caplin

given: Martyn E.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Digestive and Liver Disease

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Ipsen

location_country:
Italy
France
Czechia
Poland
Israel
Hungary
Spain
United Kingdom

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Unità di Endocrinologia Istituti Fisioterapici Ospitalieri

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: U.O.C. Malattie dell'Apparato Digerente e del Fegato

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy

summary:
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients.

This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Porter-Brown

full_name: Benjamin Porter-Brown

given: Benjamin

family: Thompson

full_name: Liz Thompson

given: Liz

family: Harari

full_name: Olivier Harari

given: Olivier

family: Dougados

full_name: Maxime Dougados

given: Maxime

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
South Africa
India
United Kingdom
Netherlands
Germany
France
Bulgaria
Lithuania
Poland
Slovakia
Belgium
Australia
Spain
Denmark
United States
Czech Republic
Canada

intervention_type: Drug

status_simplified: Unknown


ReferenceCitation: Chi KN, Higano CS, Blumenstein B, Ferrero JM, Reeves J, Feyerabend S, Gravis G, Merseburger AS, Stenzl A, Bergman AM, Mukherjee SD, Zalewski P, Saad F, Jacobs C, Gleave M, de Bono JS. Custirsen in combination with docetaxel and prednisone for patients with metastatic castration-resistant prostate cancer (SYNERGY trial): a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2017 Apr;18(4):473-485. doi: 10.1016/S1470-2045(17)30168-7. Epub 2017 Mar 8.

family: Chi

full_name: Kim N Chi

given: Kim N

family: Higano

full_name: Celestia S Higano

given: Celestia S

family: Blumenstein

full_name: Brent Blumenstein

given: Brent

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Reeves

full_name: James Reeves

given: James

family: Feyerabend

full_name: Susan Feyerabend

given: Susan

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Merseburger

full_name: Axel S Merseburger

given: Axel S

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Bergman

full_name: Andries M Bergman

given: Andries M

family: Mukherjee

full_name: Som D Mukherjee

given: Som D

family: Zalewski

full_name: Pawel Zalewski

given: Pawel

family: Saad

full_name: Fred Saad

given: Fred

family: Jacobs

full_name: Cindy Jacobs

given: Cindy

family: Gleave

full_name: Martin Gleave

given: Martin

family: de Bono

full_name: Johann S de Bono

given: Johann S

journal_name: The Lancet Oncology

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

family: de Liaño

full_name: A G de Liaño

given: A G

family: Reig

full_name: O Reig

given: O

family: Mellado

full_name: B Mellado

given: B

family: Martin

full_name: C Martin

given: C

family: Rull

full_name: E U Rull

given: E U

family: Maroto

full_name: J P Maroto

given: J P

location_country:
Italy
United States
Netherlands
Germany
France
Israel
Hungary
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility:
Teva Investigational Site 555
Teva Investigational Site 691
Teva Investigational Site 693
Teva Investigational Site 560
Teva Investigational Site 404
Teva Investigational Site 694
Teva Investigational Site 811
Teva Investigational Site 093
Teva Investigational Site 754
Teva Investigational Site 750
Teva Investigational Site 103
Teva Investigational Site 808
Teva Investigational Site 700
Teva Investigational Site 063
Teva Investigational Site 087
Teva Investigational Site 550
Teva Investigational Site 506
Teva Investigational Site 805
Teva Investigational Site 802
Teva Investigational Site 106
Teva Investigational Site 705
Teva Investigational Site 755
Teva Investigational Site 552
Teva Investigational Site 023
Teva Investigational Site 557
Teva Investigational Site 406
Teva Investigational Site 505
Teva Investigational Site 559
Teva Investigational Site 853
Teva Investigational Site 608
Teva Investigational Site 800
Teva Investigational Site 813
Teva Investigational Site 695
Teva Investigational Site 002
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Teva Investigational Site 102
Teva Investigational Site 860
Teva Investigational Site 086
Teva Investigational Site 502
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Teva Investigational Site 803
Teva Investigational Site 604
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Teva Investigational Site 607
Teva Investigational Site 752
Teva Investigational Site 566
Teva Investigational Site 606
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Teva Investigational Site 091
Teva Investigational Site 601
Teva Investigational Site 098
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Teva Investigational Site 609
Teva Investigational Site 108
Teva Investigational Site 112
Teva Investigational Site 266
Teva Investigational Site 104
Teva Investigational Site 617
Teva Investigational Site 616
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Teva Investigational Site 602
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Teva Investigational Site 701
Teva Investigational Site 614
Teva Investigational Site 852
Teva Investigational Site 864
Teva Investigational Site 059
Teva Investigational Site 028
Teva Investigational Site 097
Teva Investigational Site 806
Teva Investigational Site 024
Teva Investigational Site 765
Teva Investigational Site 564
Teva Investigational Site 804
Teva Investigational Site 698
Teva Investigational Site 096
Teva Investigational Site 807
Teva Investigational Site 618
Teva Investigational Site 703
Teva Investigational Site 862
Teva Investigational Site 610
Teva Investigational Site 553
Teva Investigational Site 764
Teva Investigational Site 759
Teva Investigational Site 047
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Teva Investigational Site 204
Teva Investigational Site 763
Teva Investigational Site 810
Teva Investigational Site 026
Teva Investigational Site 816
Teva Investigational Site 710
Teva Investigational Site 118
Teva Investigational Site 756
Teva Investigational Site 753
Teva Investigational Site 562
Teva Investigational Site 501
Teva Investigational Site 004
Teva Investigational Site 107
Teva Investigational Site 561
Teva Investigational Site 507
Teva Investigational Site 709
Teva Investigational Site 600
Teva Investigational Site 100
Teva Investigational Site 696
Teva Investigational Site 025
Teva Investigational Site 084
Teva Investigational Site 401
Teva Investigational Site 611
Teva Investigational Site 085
Teva Investigational Site 605
Teva Investigational Site 760
Teva Investigational Site 405
Teva Investigational Site 403
Teva Investigational Site 563
Teva Investigational Site 809
Teva Investigational Site 612
Teva Investigational Site 551
Teva Investigational Site 032
Teva Investigational Site 762
Teva Investigational Site 094
Teva Investigational Site 699
Teva Investigational Site 815
Teva Investigational Site 001
Teva Investigational Site 263
Teva Investigational Site 851
Teva Investigational Site 697
Teva Investigational Site 116
Teva Investigational Site 558
Teva Investigational Site 758
Teva Investigational Site 692
Teva Investigational Site 503
Teva Investigational Site 101
Teva Investigational Site 761
Teva Investigational Site 603
Teva Investigational Site 615
Teva Investigational Site 090

title: A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer

summary: This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.


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

acronym: PREPS EXT

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

design_allocation: Non-Randomized

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

location_country: Switzerland Finland France Poland Belgium Portugal


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

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

primary_purpose: Prevention

ReferenceType: background

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

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

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

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

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Finland
France
Spain
Germany
Czech Republic

intervention_type: Biological


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

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

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

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


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

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

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