Thorough QT/QTc Clinical Trials

摘要: On an ECG tracing, the QT interval is measured from beginning of Q wave to end T wave. reflects duration ventricular depolarization and subsequent repolarization. For some drugs, significant prolongation absolute has been associated with precipitation a potentially fatal cardiac arrhythmia called Torsades de Pointes (TdP) can degenerate into fibrillation, leading sudden death (Moss 1993). Over past decade, these adverse events have resulted in number patient deaths was one most frequent (Wysowski et al. 2001) drug that led either its removal market (e.g., terfenadine cisapride) or placement restrictions on use ziprasidone ranolizine.) With theses experiences, regulatory agencies now request each pharmaceutical company conducts at least thorough (TQT) study when submitting new application. The final version ICH E14 guidance (ICH 2005) for “The Clinical Evaluation QT/QTc Interval Prolongation Proarrhythmic Potential Nonantiarrhythmic Drugs” released May 2005. abbreviation QTc denotes corrected heart rate.