ECG data in Phase 3 trials
ECG data from 3013 added to previous NDA*
Mean on-therapy ?QTC (Bazett’s formula):
- 1.5 ? 22.3 msec in telithromycin-treated patients for all Phase 3 trials combined
- 3.8 ? 19.3 msec for telithromycin vs. 3.3 ? 19.6 msec for clarithromycin in controlled studies (3006, 3008, 3013)
* ECG data not consistently collected for new studies 4003 and 3012