Table I.
Demographic and Baseline Characteristics of Study Participants Entering the Open‐Label Study by Final Dosing Regimena
| OM 40/AML 5/HCTZ 12.5 mg (n=869) | OM 40/AML 5/HCTZ 25 mg (n=246) | OM 40/AML 10/HCTZ 12.5 mg (n=239) | OM 40/AML 10/HCTZ 25 mg (n=758) | |
|---|---|---|---|---|
| Age, mean (SD), y | 54.6 (10.8) | 57.0 (10.5) | 55.6 (11.4) | 55.8 (10.3) |
| Age group, No. (%) | ||||
| <65 y | 722 (83.1) | 188 (76.4) | 179 (74.9) | 609 (80.3) |
| ≥65 y | 147 (16.9) | 58 (23.6) | 60 (25.1) | 149 (19.7) |
| ≥75 y | 25 (2.9) | 10 (4.1) | 8 (3.3) | 23 (3.0) |
| Sex, No. (%) | ||||
| Male | 429 (49.4) | 114 (46.3) | 135 (56.5) | 448 (59.1) |
| Ethnicity | ||||
| Hispanic or Latino | 125 (14.4) | 47 (19.1) | 37 (15.5) | 100 (13.2) |
| Race, No. (%)b | ||||
| White | 629 (72.4) | 175 (71.1) | 149 (62.3) | 477 (62.9) |
| Black | 211 (24.3) | 63 (25.6) | 84 (35.1) | 264 (34.8) |
| Asian | 21 (2.4) | 4 (1.6) | 4 (1.7) | 10 (1.3) |
| Other | 10 (1.1) | 5 (2.0) | 3 (1.2) | 9 (1.1) |
| BMI, mean (SD), kg/m2 | 32.0 (6.7) | 33.8 (7.3) | 32.5 (7.1) | 34.6 (7.4) |
| BMI category, No. (%) | ||||
| BMI <30 kg/m2 | 370 (42.6) | 87 (35.4) | 105 (43.9) | 218 (28.8) |
| BMI ≥30 kg/m2 | 499 (57.4) | 159 (64.6) | 134 (56.1) | 540 (71.2) |
| Diabetes, No. (%) | 63 (7.2) | 34 (13.8) | 40 (16.7) | 197 (26.0) |
| Chronic kidney disease, No. (%)c | 30 (3.5) | 13 (5.3) | 14 (5.9) | 36 (4.7) |
| Chronic cardiovascular disease, No. (%) | 55 (6.3) | 30 (12.2) | 20 (8.4) | 86 (11.3) |
| Duration of hypertension, mean (SD), y | 8.6 (8.6) | 9.5 (9.3) | 11.3 (9.7) | 11.7 (10.4) |
| Baseline SeSBP, mean (SD), mm Hgd | 163.8 (11.8) | 169.6 (13.0) | 167.8 (12.6) | 174.1 (14.7) |
| Baseline SeDBP, mean (SD), mm Hgd | 99.8 (6.9) | 100.5 (7.4) | 100.5 (7.2) | 102.0 (8.5) |
Abbreviations: AML, amlodipine besylate; BMI, body mass index; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; SD, standard deviation; SeDBP, seated diastolic blood pressure; SeSBP, seated systolic blood pressure. aBaseline data were collected prior to randomization into the double‐blind period of the study. bStudy participants could select more than one race. cDefined as screening creatinine clearance ≥30 mL/min and ≤60 mL/min. dBaseline BP was defined as the mean of the randomization visit and the visit immediately preceding randomization.