Table 4.
Vital Sign | Placebo, n = 59 | Solriamfetol | |||
---|---|---|---|---|---|
75 mg, n = 59 | 150 mg, n = 59 | 300 mg, n = 59 | All Doses, n = 177 | ||
Patients with clinical laboratory assessment data at week 12, na | 50 | 48 | 49 | 43 | 140 |
Heart rate, beats/min | 0.5 ± 6.7 | 0.6 ± 6.6 | 2.5 ± 4.7 | 4.3 ± 7.6 | 2.4 ± 6.5 |
Blood pressure, mmHg | |||||
Systolic | 0.6 ± 8.1 | 0.3 ± 6.8 | 1.2 ± 7.4 | 2.0 ± 7.4 | 1.2 ± 7.2 |
Diastolic | −0.6 ± 5.2 | 1.0 ± 4.4 | 1.4 ± 4.9 | 2.1 ± 5.0 | 1.5 ± 4.8 |
Ambulatory blood pressure monitoring in safety population at week 8, nb | 50 | 46 | 46 | 41 | 133 |
Heart rate, beats/min | −0.6 ± 7.0 | 1.0 ± 8.0 | 0.7 ± 7.1 | 5.3 ± 7.6 | 2.2 ± 7.8 |
Blood pressure, mmHg | |||||
Systolic | −0.3 ± 9.3 | 1.8 ± 6.5 | −0.5 ± 5.5 | 2.4 ± 6.0 | 1.2 ± 6.1 |
Diastolic | −0.1 ± 7.2 | 1.4 ± 5.1 | 0.4 ± 4.5 | 3.0 ± 5.0 | 1.6 ± 4.9 |
Values are mean ± standard deviation.
Vital signs averaged across predose to 9 hours postdose.
Vital signs matched by time point at baseline and week 8.