Table 4.
Summary of vital signs, weight and ECG parameters (safety population)
| LDX (n = 128) | ATX (n = 134) | |
|---|---|---|
| Systolic blood pressure (mmHg) | ||
| Baseline, mean (SD) | 107.9 (10.43) | 106.2 (9.91) |
| Endpoint, mean change (SD) | +0.7 (9.08) | +0.6 (7.96) |
| Diastolic blood pressure (mmHg) | ||
| Baseline, mean (SD) | 65.9 (8.32) | 65.5 (7.98) |
| Endpoint, mean change (SD) | +0.1 (8.33) | +1.3 (8.24) |
| Pulse (bpm) | ||
| Baseline, mean (SD) | 78.0 (10.11) | 79.6 (9.18) |
| Endpoint, mean change (SD) | +3.6 (10.49) | +3.7 (10.75) |
| Weight (kg) | ||
| Baseline, mean (SD) | 42.33 (16.618) | 39.60 (14.639) |
| Endpoint, mean change (SD) | −1.30 (1.806) | −0.15 (1.434) |
| Heart rate (ECG assessment) (bpm) | ||
| Screening, mean (SD) | 75.4 (11.72) | 77.1 (10.24) |
| Visit 4, mean change (SD) | +3.5 (12.73) | +6.4 (10.08) |
| QTcF interval (ms) | ||
| Screening, mean (SD) | 371.1 (17.72) | 371.2 (17.00) |
| Visit 4, mean change (SD) | −0.3 (14.74) | +1.9 (13.41) |
Endpoint is the last on-treatment, post-baseline visit with a valid assessment. The visit 4 ECG was added as a result of a protocol amendment, and therefore an ECG was only obtained for some patients at this visit (LDX, n = 76; ATX, n = 83)
ATX atomoxetine, bpm beats per minute, ECG electrocardiogram, LDX lisdexamfetamine dimesylate, QTcF QT interval corrected using Fridericia’s formula, SD standard deviation