TABLE 5

Cardiac Parameters Throughout the Study (Safety Population)

Mean HR, bpm (SD)Blood Pressure, Mean (SD)ECG Intervals, Mean (SD)
SBP, mm HgDBP, mm HgQT, millisecondsQTcB, millisecondsQTcF, millisecondsQRS, milliseconds
Placebo plus stimulant (n = 96)a
    Baseline83.8 (12)107.9 (12)67.8 (9)355.8 (21)413.2 (16)392.8 (12)86.1 (6)
    Week 185.1 (11)108.7 (10)67.7 (8)353.3 (23)414.8 (18)392.9 (16)85.9 (6)
    Week 286.7 (13)108.0 (13)67.3 (9)353.4 (22)414.4 (17)392.7 (13)86.2 (6)
    Week 386.0 (13)108.8 (10)67.7 (7)354.1 (24)415.6 (17)393.4 (14)85.9 (3)
    Week 486.0 (12)108.6 (11)68.0 (7)356.3 (24)414.2 (20)393.7 (15)86.1 (6)
    Week 584.7 (13)108.3 (10)67.7 (8)352.6 (20)424.9 (9)399.3 (8)86.3 (5)
    Week 684.3 (11)109.0 (10)67.6 (7)353.7 (23)414.3 (21)392.7 (16)85.7 (6)
    Week 786.0 (12)108.2 (10)66.8 (7)355.8 (6)421.3 (10)398.3 (7)84.3 (4)
    Week 886.9 (14)109.3 (12)67.4 (7)353.5 (26)413.0 (18)391.8 (15)85.7 (6)
    Week 986.9 (11)109.5 (10)68.1 (7)356.5 (23)413.8 (21)393.5 (17)86.9 (6)
CLON-XR Plus stimulant (n = 102)a
    Baseline84.8 (12)108.2 (10)67.5 (8)357.8 (26)415.2 (16)394.8 (15)85.2 (6)
    Week 182.5 (12)104.7 (11)65.7 (8)362.0 (25)413.8 (18)395.5 (16)85.6 (6)
    Week 279.8 (12)104.1 (11)63.8 (8)367.2 (25)409.8 (22)394.7 (17)85.6 (6)
    Week 379.8 (12)103.9 (11)64.0 (8)372.9 (27)412.5 (21)398.7 (20)86.4 (6)
    Week 480.2 (14)103.5 (11)64.4 (8)371.1 (29)412.2 (22)397.6 (18)85.9 (6)
    Week 580.1 (12)104.7 (12)66.8 (8)380.3 (19)408.1 (27)398.0 (20)88.3 (5)
    Week 683.3 (11)105.1 (11)66.1 (9)366.6 (24)418.1 (18)399.8 (14)86.9 (6)
    Week 784.0 (13)105.0 (11)66.3 (8)350.5 (21)411.6 (18)389.8 (12)86.4 (7)
    Week 886.5 (12)110.7 (11)69.9 (8)352.5 (24)419.1 (18)395.3 (14)84.9 (6)
    Week 988.0 (12)111.7 (10)70.6 (7)350.8 (24)421.0 (20)395.8 (15)85.5 (6)
  • ECG indicates electrocardiogram; HR, heart rate; SBP, systolic blood pressure; DBP, diastolic blood pressure; QTcB, QT interval corrected using Bazett's formula; QTcF, QT interval corrected using Fridericia's formula.

  • a Sample size n may vary from visit to visit because of missed visits, dropout, or unscheduled visits (eg, 12-lead ECGs were not planned for all patients at weeks 3, 5, and 7).