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2017 cardiovascular and stroke endpoint definitions for clinical trials

Autor: Karen A. Hicks, Kenneth W. Mahaffey, Roxana Mehran, Steven E. Nissen, Stephen D. Wiviott, Billy Dunn, Scott D. Solomon, John R. Marler, John R. Teerlink, Andrew Farb, David A. Morrow, Shari L. Targum, Cathy A. Sila, Mary T. Thanh Hai, Michael R. Jaff, Hylton V. Joffe, Donald E. Cutlip, Akshay S. Desai, Eldrin F. Lewis, C. Michael Gibson, Martin J. Landray, A. Michael Lincoff, Christopher J. White, Steven S. Brooks, Kenneth Rosenfield, Michael J. Domanski, Alexandra J. Lansky, John J.V. McMurray, James E. Tcheng, Steven R. Steinhubl, Paul Burton, Laura Mauri, Christopher M. O’Connor, Marc A. Pfeffer, H.M. James Hung, Norman L. Stockbridge, Bernard R. Chaitman, Robert J. Temple, Heather D. Fitter, Kachikwu Illoh, Kenneth J. Cavanaugh, Benjamin M. Scirica, Ilan Irony, Rachel E. Brown Kichline, Jonathan G. Levine, Anna Park, Leonard Sacks, Ana Szarfman, Ellis F. Unger, Lori Ann Wachter, Bram Zuckerman, Yale Mitchel, Douglas Peddicord, Thomas Shook, Bron Kisler, Charles Jaffe, Rhonda Bartley, David L. DeMets, MariJo Mencini, Cheri Janning, Steve Bai, John Lawrence, Ralph B. D’Agostino, Stuart J. Pocock

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardiz

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3cde835e4f8afd6f69798ebf241a2498
https://ora.ox.ac.uk/objects/uuid:b37d1048-c70b-4de9-88fb-0de0f2046181

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Autor: Phillip Dinh, George Kordzakhia, Steve Bai, Jin Sun

Publikováno v: Reviews on Recent Clinical Trials. 6:220-227

The objective of this study was to examine the drug-induced sex differences in corrected QT (QTc) interval by re-analyzing the data collected in thorough QT studies submitted to the US Food and Drug Administration (FDA). We examined 64 studies availa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::435b2762277fb4fd56fb14f7a8bbbee5
https://doi.org/10.2174/157488711796575531

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Regional treatment effects in studies of cardiorenal drugs: a summary of recent clinical trials

Autor: John, Lawrence, Steve, Bai, H M James, Hung, Robert, O'Neill

Publikováno v: Journal of the American College of Cardiology. 60(12)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::09788336643f554df98794f1ee4ca48d
https://pubmed.ncbi.nlm.nih.gov/22939557

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Aminobenzisoxazoles with Biaryl P4 Moieties as Potent, Selective, and Orally Bioavailable Factor Xa Inhibitors

Autor: John M. Fevig, Mimi L. Quan, Qi Han, Steve Bai, Patrick Y.S. Lam, Pancras C. Wong, Robert M. Knabb, Joseph M. Luettgen, Ruth R. Wexler

Publikováno v: ChemInform. 37

We have previously reported on a series of aminobenzisoxazoles as potent, selective, and orally bioavailable factor Xa inhibitors, which culminated in the discovery of razaxaban. Herein, we describe another approach to improve factor Xa inhibitory po

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f25c16e1620c8b8999eeba5ac229492d
https://doi.org/10.1002/chin.200628125

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Discovery of 1-(3'-aminobenzisoxazol-5'-yl)-3-trifluoromethyl-N-[2-fluoro-4- [(2'-dimethylaminomethyl)imidazol-1-yl]phenyl]-1H-pyrazole-5-carboxyamide hydrochloride (razaxaban), a highly potent, selective, and orally bioavailable factor Xa inhibitor

Autor: Pancras C. Wong, Patrick Y.S. Lam, Donald J. P. Pinto, Robert M. Knabb, Renhua Li, Richard S. Alexander, Steve Bai, Jung-Hui Sun, Mimi L. Quan, Christopher A. Teleha, Joseph M. Luettgen, Ming Y. He, Qi Han, Charles G. Clark, Ruth R. Wexler, Christopher D. Ellis

Publikováno v: Journal of medicinal chemistry. 48(6)

Modification of a series of pyrazole factor Xa inhibitors to incorporate an aminobenzisoxazole as the P(1) ligand resulted in compounds with improved selectivity for factor Xa relative to trypsin and plasma kallikrein. Further optimization of the P(4

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d7c310b45752e653fb30c34cbea4e88b
https://pubmed.ncbi.nlm.nih.gov/15771420

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Regional Treatment Effects in Studies of Cardiorenal Drugs

Autor: Steve Bai, Robert T. O'Neill, John H. Lawrence, H.M. James Hung

Publikováno v: Journal of the American College of Cardiology. 60(12):1117-1118

To the Editor: The global treatment effect in a multinational trial design can be difficult to interpret when that global treatment effect does not reflect a consistent finding within the trial regional sites. This global treatment effect may not app

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7354fabae29374fb1c320a846eeac3d6

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