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Original Research

Absence of QTc prolongation with betrixaban: a randomized, double-blind, placebo- and positive-controlled thorough ECG study

, , , & , PhD
Pages 5-13 | Published online: 10 Dec 2012

Bibliography

  • Sinha U, Delaney SM, Nanda N, Antithrombotic activity of PRT54021, a potent oral direct factor Xa inhibitor, can be monitored using a novel prothrombinase inhibition bioassay [abstract 907]. Blood 2006;108:11
  • Abe K, Siu G, Edwards ST, Animal models of thrombosis help predict the human therapeutic concentration of PRT54021, a potent oral factor Xa inhibitor [abstract 901]. Blood 2006;108:11
  • Cindy Xia. Absorption mechanism of MLN1021 in Caco-2 cells. Portola Pharmaceuticals, Inc; South San Francisco, CA: 2004; Data on file
  • Katzer D, Eggen M, Kollipara SA. An open-label, single-dose, mass-balance study to assess the disposition of 14C-labeled PRT054021 in healthy male subjects. Portola Pharmaceuticals, Inc; South San Francisco, CA: 2007; Data on file
  • Turpie AGG, Bauer KA, Davidson BL, A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT). Thromb Haemost 2009;101(1):68-76
  • Ezekowitz M, Diaz R, Dorian P, Randomized Clinical Trial of Three Doses of a Long-Acting Oral Direct Factor Xa Inhibitor Betrixaban in Patients with Atrial Fibrillation [abstract]. 59th Annual Meeting of the American Academy of Cardiology; 13 – 16 March 2010; Atlanta (GA)
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. October 2005. Issued by the Approved by the International Conference on Harmonisation. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf
  • Woosley RL, Chen Y, Freiman JP, Mechanisms of the cardiotoxic actions of terfenadine. JAMA 1993;268(12):1532-6
  • Morganroth J. A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment. J Electrocardiol 2004;37(1):25-9
  • Gupta A, Lawrence AT, Krishnan K, Current concepts in the mechanisms and management of drug-induced QT prolongation and torsade de pointes. Am Heart J 2007;153(6):891-9
  • Bloomfield DM, Kost JT, Ghosh K, The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther 2008;84(4):679-3
  • Demolis JL, Kubitza D, Tenneze L, Effect of a single oral dose of moxifloxacin (400 mg and 800 mg) on ventricular repolarization in healthy subjects. Clin Pharmacol Ther 2000;68(6):658-66
  • Malik M, Farbom P, Batchvarov V, Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart 2002;87(3):220-8
  • Bazett HC. An analysis of the time-relations of electrocardiograms. Heart 1920;7:353-69
  • Fridericia LS. The duration of systole in an electrocardiogram in normal humans and in patients with heart disease. Ann Noninvasive Electrocardiol 2003;8(4):343-51

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