Table 1.
Demographic and Baseline Characteristics
| Parameter | Open‐Label Phase (Baseline=Week 0) | Randomized, Double‐Blind Reversal Phase (Baseline=Week 26) | |||
|---|---|---|---|---|---|
| Total Cohort | AZL‐M a | AZL‐M+CLD b | AZL‐M | Placebo | |
| No. | 418 | 179 | 239 | 148 | 151 |
| Sex, No. (%) | |||||
| Male | 208 (49.8) | 83 (46.4) | 125 (52.3) | 72 (48.6) | 77 (51.0) |
| Female | 210 (50.2) | 96 (53.6) | 114 (47.7) | 76 (51.4) | 74 (49.0) |
| Age, mean±SD, y | 52.1±10.1 | 50.4±10.2 | 53.3±10.0 | 52.9±9.6 | 51.8±9.7 |
| Race, No. (%)c | |||||
| American Indian/Alaska Native | 32 (7.7) | 18 (10.1) | 14 (5.9) | 10 (6.8) | 9 (6.0) |
| Asian | 4 (1.0) | 4 (2.2) | 0 | 1 (0.7) | 2 (1.3) |
| Black/African American | 99 (23.7) | 27 (15.1) | 72 (30.1) | 30 (20.3) | 38 (25.2) |
| White | 287 (68.7) | 132 (73.7) | 155 (64.9) | 107 (72.3) | 104 (68.9) |
| Multiracial | 4 (1.0) | 2 (1.1) | 2 (0.8) | 0 | 2 (1.3) |
| BMI, mean±SD, kg/m2 | 33.1±6.5 | 33.2±6.7 | 33.0±6.3 | 33.2±6.7 | 33.1±6.5 |
| Baseline DBP, mean±SD, mm Hg | 99.9±7.1 | 98.2±7.3 | 101.2±6.6 | 83.7±8.2 | 82.3±10.2 |
| Baseline SBP, mean±SD, mm Hg | 155.1±14.3 | 150.8±14.8 | 158.3±13.0 | 130.3±16.1 | 128.3±16.2 |
Abbreviations: AZL‐M, azilsartan medoxomil; BMI, body mass index; DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation. Note that the individual columns in italics do not represent randomized groups and are part of a single cohort (ie, they are presented separately according to treatment received for clarity). aPatients who did not require additional treatment with chlorthalidone (CLD) during the open‐label phase. bPatients who required additional treatment with CLD after week 8 during the open‐label phase. cPatients who indicated more than 1 race category were included in each category indicated and also in the multiracial category.