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;
Parallel
H077 sustained-release tablet
DrugSubjects are administered one H077 sustained-release tablet (8 mg) orally once daily, along with one silodosin capsule (placebo) orally twice daily.
Silodosin capsules Control Group
DrugSubjects are administered one Silodosin capsule (4 mg) twice daily, along with one H077 sustained-release tablet placebo once daily, orally.
changes in International Prostatism Symptom Score (IPSS) at 12 weeks from baseline
The study set the change in the IPSS of patients after 12 weeks of medication compared to the baseline data as the primary endpoint. The IPSS is currently the internationally recognized best method for assessing the severity of symptoms in patients with benign prostatic hyperplasia. The IPSS scale is used to evaluate the severity of 7 urinary symptoms, namely: incomplete urination, frequent urination, intermittent urine flow, urgency, weak urine stream, difficulty in urination, and nocturia frequency. Each of the 7 symptoms is scored in 6 segments based on the occurrence in the last month (0-5 points, 0 indicates no occurrence, 5 indicates almost always occurring). The total score is 35 points, and the patient's symptoms are classified as mild (0-7 points), moderate (8-19 points), and severe (20-35 points).
changes in IPSS at 1, 2, 4, and 8 weeks from baseline
The changes in the IPSS compared to the baseline after 1, 2, 4, and 8 weeks of medication administration.
quality of life (QOL) scores
The QOL score is used to understand the patient's subjective perception of their current level of lower urinary tract symptoms throughout their lifetime. It mainly focuses on the extent to which BPH patients are troubled by lower urinary tract symptoms and whether they can tolerate it. Based on subjective feelings, it is classified as: happy, satisfied, generally satisfied, acceptable, not very satisfied, distressed, and very bad. The scores range from 0 to 6.
The proportion of subjects whose IPSS scores changed by ≥ 3 points or improved by ≥ 25% compared to the baseline
The proportion of subjects whose IPSS scores changed by ≥ 3 points or improved by ≥ 25% compared to the baseline after 1, 2, 4, 8, and 12 weeks of medication administration.
maximum urine flow rate (Qmax) changes
The changes in the maximum urine flow rate (Qmax) compared to the baseline after 2, 4, 8, and 12 weeks of medication administration.
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