Why the study?
Does the choice of baseline ECG collection method affect the analysis of moxifloxacin-induced QTc prolongation in a thorough QT study?
Population
30 subjects in a 5-arm cross-over thorough QT study (TQTS)
Comparison
Different baseline ECG collection methods for… vs Comparison among the four baseline ECG…
Design
Other
Follow-up
up to 12 hours post-dose
Authors
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TM EACH baselines yield lowest QTc variability; hypothesis-generating for efficient predose designs in small TQT studies pending larger validation.
Does the choice of baseline ECG collection method affect the analysis of moxifloxacin-induced QTc prolongation in a thorough QT study?
While collecting time-matched baseline ECGs before each period yields the lowest variability, more cost-effective designs like predose baseline are sufficient to detect moxifloxacin-induced QTc prolongation in small studies.
Tyl (2009) studied this question.
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