This is a randomized, double-blind, controlled, non-inferiority multicenter Phase III clinical study to evaluate the efficacy and safety of H077 sustained-release tablets versus silodosin capsules in treating benign prostatic hyperplasia.
Male, aged 50 to 75 years old, inclusive of both endpoints;
Meets the clinical diagnostic criteria for benign prostatic hyperplasia (BPH);
IPSS score was ≥ 8 points, and the QOL score was ≥ 3 points during the screening period;
Prostate volume ≥ 20 ml (measured by transabdominal ultrasound);
Those who are allergic to any component of α/β-adrenergic receptor blockers or the test drugs; or who have contraindications;
History or evidence of prostate cancer (such as positive biopsy or ultrasound result, suspicious DRE findings), excluding patients who had suspicious ultrasound or DRE findings within 6 months prior to the screening but had negative biopsy results and stable PSA levels;
During the screening process, researchers identified patients with BPH who required minimally invasive prostate treatment or surgical intervention;
Has previously undergone prostate surgery, including open prostate surgery, transurethral minimally invasive prostate surgery, balloon dilation or stent replacement, or other invasive measures for treating BPH;
Shanghai Huilun Pharmaceutical Co., Ltd.
Lead sponsor