Table 7.
Difference in Heart Rate and Blood Pressure between Placebo and Active Treatment Arms at Different Time Points
| Arm | HR, beats/min |
SBP, mm Hg |
DBP, mm Hg |
||||
|---|---|---|---|---|---|---|---|
| Evening | Overnight* | Morning | Evening | Morning | Evening | Morning | |
| Ato75 | 3.7 (−0.5 to 7.8) | 7.7 (5.7 to 9.6) | 7.0 (3.3 to 10.6) | −2.7 (−8.9 to 3.6) | −0.8 (−5.3 to 3.8) | 1.5 (−1.7 to 4.7) | 1.2 (−2.1 to 4.5) |
| AD109 2.5/75 mg | 2.0 (−2.8 to 6.7) | 5.1 (2.9 to 7.4) | 5.5 (1.4 to 9.6) | 3.4 (−3.6 to 10.3) | 1.9 (−3.2 to 7.0) | 4.7 (1.1 to 8.3) | 4.2 (0.5 to 7.9) |
| AD109 5/75 mg | 1.5 (−3.1 to 6.1) | 5.5 (3.3 to 7.7) | 7.4 (3.4 to 11.4) | −3.3 (−10.1 to 3.5) | −4.0 (−9.0 to 1.1) | 0.5 (−3.0 to 4.0) | −0.8 (−4.4 to 2.8) |
Definition of abbreviations: Ato75 = atomoxetine 75 mg, HR = heart rate, DBP = diastolic blood pressure, SBP = systolic blood pressure.
Data show mean (95% confidence interval) difference from placebo derived from the average of the two treatment polysomnography nights. Evening values were obtained before dosing.
*
HR overnight data are additionally adjusted for baseline.