Table 5.
Safety Comparison by Placebo and Treatment group at each assessment period.
| Group | Group | ||||||
|---|---|---|---|---|---|---|---|
| Variable | Placebo | Treatment | p-Value * | Variable | Placebo | Treatment | p-Value * |
| SBP | WBC | ||||||
| Screening | 100 ± 5 | 100 ± 7 | 0.4772 | Screening | 6.65 ± 1.03 | 7.41 ± 0.93 | - |
| At week 12 | 100 ± 8 | 90 ± 8 | 0.2815 | At week 12 | 6.79 ± 2.06 | 7.15 ± 2.24 | 0.4971 |
| DBP | Uric acid | ||||||
| Screening | 65 ± 7 | 60 ± 8 | 0.2652 | Screening | 3.9 ± 0.6 | 4.1 ± 1.0 | 0.3695 |
| At week 12 | 60 ± 10 | 60 ± 9 | 0.3423 | At week 12 | 4.1 ± 1.0 | 3.8 ± 0.7 | 0.1371 |
| Pulse | Na | ||||||
| Screening | 82 ± 8 | 84 ± 6 | 0.4238 | Screening | 140 ± 1 | 140 ± 1 | 0.3813 |
| At week 12 | 78 ± 7 | 81 ± 5 | 0.1444 | At week 12 | 141 ± 2 | 140 ± 2 | 0.2341 |
| K | HDL-C | ||||||
| Screening | 4.2 ± 0.5 | 4.5 ± 0.4 | - | Screening | 66 ± 12 | 67 ± 12 | 0.4286 |
| At week 12 | 4.3 ± 0.3 | 4.1 ± 0.5 | 0.4787 | At week 12 | 62 ± 11 | 64 ± 14 | 0.4605 |
| Hemoglobin | LDL-C | ||||||
| Screening | 12.8 ± 0.8 | 13.2 ± 0.4 | 0.4078 | Screening | 90 ± 18 | 108 ± 29 | 0.4286 |
| At week 12 | 13.5 ± 0.8 | 13.3 ± 0.3 | 0.3671 | At week 12 | 89 ± 21 | 115 ± 22 | 0.4605 |
SBP: systolic blood pressure, WBC: white blood cellm, DBP: diastolic blood pressure, K: potassium, Na: sodium, HDL-C: high density lipoprotein cholesterol, LDL-C: low density lipoprotein cholesterol. * p-values were adjusted for observed value at screening and week 12 by using screening values as the covariate in analysis of covariance and derived from independent t-test.