Changes from before to after azelnidipine treatment were analyzed using a paired t-test. Values were expressed as means ± standard deviations (SDs). Figure 1 shows the patient classification system using ME average and ME difference as measures. The cut-off values of ME average and ME difference were 135 mmHg and 15 mmHg, respectively. Evaluation was carried out in the following four

groups: those with normal BP OICR-9429 (ME average of <135 mmHg and ME difference of <15 mmHg); those with normal BP with a Cobimetinib morning BP surge pattern (ME average of <135 mmHg and ME difference of ≥15 mmHg); those with morning-predominant hypertension (ME average of ≥135 mmHg and ME difference of ≥15 mmHg); and those with sustained hypertension (ME average of ≥135 mmHg and ME difference of <15 mmHg). Changes in the patient distribution based on ME average and ME difference from before to after azelnidipine treatment were evaluated using BIBF 1120 nmr the McNemar test. All tests were two-sided, with the significance level being set at p = 0.05. Adverse events and adverse drug reactions were coded using the Medical Dictionary for Regulatory Activities (MedDRA)/J version 11.0 and classified according to their Preferred

Terms. 3 Results 3.1 Patient Disposition Figure 2 shows the patient disposition. After exclusion of patients with no evening home BP measurement within 28 days prior to the baseline date, 2,590 and 2,546 patients were included in the safety and efficacy analysis populations, respectively. Fig. 2 Patient disposition in the current study. BP blood pressure 3.2 Patient Characteristics Table 1 shows the patient characteristics at baseline. The mean age was 65.1 ± 11.7 years, and 53.6 % of patients were female. The mean baseline home systolic BP (SBP)/diastolic BP (DBP) values were 156.9 ± 16.1/89.7 ± 11.7 mmHg in the morning and 150.2 ± 17.6/85.6 ± 12.2 mmHg in the evening. The mean pulse rates were 72.1 ± 10.2 beats/min in the morning

and 72.5 ± 9.6 beats/min in the evening. During the observation period, morning home BP was usually measured before breakfast and before dosing in a large proportion (86.8 %) of cases. Table 1 Patient characteristics at baseline (n = 2,546) Characteristics Value Gender (n [%])  Male 1,181 [46.4]  Female 1,365 [53.6] Age (years ± SD) Dimethyl sulfoxide 65.1 ± 11.7  15 to <65 years (n [%]) 1,168 [45.9]  65 to <75 years (n [%]) 806 [31.7]  ≥75 years (n [%]) 571 [22.4]  Not specified (n [%]) 1 [0.0] BMI (kg/m2 ± SD) 24.3 ± 3.6  <18.5 kg/m2 (n [%]) 69 [2.7]  18.5 to <25 kg/m2 (n [%]) 1,109 [43.6]  ≥25 kg/m2 (n [%]) 727 [28.6]  Not calculable (n [%]) 641 [25.2] BP and pulse rates  Morning home SBP (mmHg ± SD) 156.9 ± 16.1  Morning home DBP (mmHg ± SD) 89.7 ± 11.7  Morning home pulse rate (beats/min ± SD) 72.1 ± 10.2  Evening home SBP (mmHg ± SD) 150.2 ± 17.6  Evening home DBP (mmHg ± SD) 85.6 ± 12.2  Evening home pulse rate (beats/min ± SD) 72.5 ± 9.6 Patient classification (n [%])  Normal BP 150 [5.