Table 1.
Baseline Characteristics and Demographics
| Baseline Characteristics | Statistics |
|---|---|
| Total number of randomized patients, N |
1694 |
| Age, mean (SD) |
63.1 (8.2) |
| Peak urine flow rate (Qmax) |
|
| Mild (Qmax > 15 ml/s), n (%) |
11 (0.7%) |
| Moderate (Qmax 10–15 ml/s), n (%) |
837 (50.7%) |
| Severe (Qmax < 10 ml/s), n (%) |
802 (48.6%) |
| PSA (mg/L), mean (SD) |
1.8 (1.6) |
| PVR (mL), mean (SD) |
38.1 (42.0) |
| LUTS Severity |
|
| Moderate (IPSS 8–19), n (%) |
1090 (64.4%) |
| Severe (IPSS >= 20), n (%) |
603 (35.6%) |
| Race/Ethinity |
|
| Asian, n (%) |
763(45.0%) |
| Caucasian, n (%) |
861(50.8%) |
| Hispanic Caucasian, n (%) |
164 (9.7%) |
| Non-Hispanic Caucasian, n (%) |
697 (41.1%) |
| Other Race, n (%) | 70 (4.1%) |
SD: standard deviation; n: number of patients; PSA: Prostate-specific antigen; PVR: post-void residual urine volume; LUTS: Lower Urinary Tract Symptoms; Asian: from the 2 studies conducted in Asia; Caucasian/Other race: from the 2 studies conducted outside Asia. Values are from V1-V2, before enrolled into the single-blind placebo run in period.