A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment
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Cited by (47)
Review of T-wave morphology-based biomarkers of ventricular repolarisation using the surface electrocardiogram
2012, Biomedical Signal Processing and ControlCitation Excerpt :Pharmaceutical companies are justifiably concerned about drug-induced QT prolongation because every drug associated with ventricular arrhythmia has been shown to prolong the QT interval [5]. Furthermore, QT prolongation is now the primary cause of delays in drug development, the non-approval of candidate drugs and the withdrawal of approved drugs from the market [6,7]. Despite QT interval prolongation being the standard indicator (or biomarker) of cardiac safety in clinical trials, there are several limitations associated with the QT interval.
A study on electrocardiographic changes secondary to the use of tricyclic antidepressants in patients with chronic pain
2009, Revista Brasileira de AnestesiologiaChoice of cardiac tissue in vitro plays an important role in assessing the risk of drug-induced cardiac arrhythmias in human: Beyond QT prolongation
2008, Journal of Pharmacological and Toxicological MethodsIncreased survival with enzalutamide in prostate cancer after chemotherapy
2012, New England Journal of MedicineCitation Excerpt :Liver-function abnormalities were reported as adverse events in 1% of patients receiving enzalutamide and in 2% of those receiving placebo. A comprehensive evaluation of electrocardiographic data, including the QT interval and the QT interval corrected for heart rate (QTc), revealed no clinically relevant changes in heart rate, atrioventricular conduction, cardiac depolarization, or effect on cardiac repolarization as determined by means of the QTc according to Fridericia's formula.21 Five of the 800 patients in the enzalutamide group (0.6%) were reported by the investigators to have had a seizure; no seizures were reported in the placebo group.
An open-label, multicenter, phase Ib study investigating the effect of apalutamide on ventricular repolarization in men with castration-resistant prostate cancer
2018, Cancer Chemotherapy and Pharmacology