A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in … (NCT07146386) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia
China728 participantsStarted 2025-08
Plain-language summary
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.
Who can participate
Age range50 Years – 75 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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);
✓. PSA≤4 ng/mL;
✓. During the screening period, Qmax \> 5 ml/s and Qmax \<15 ml/s (urine output ≥ 125 ml);
✓. The subjects had no intention of having children from the screening stage until 6 months after the last administration of the drug, and they were able to take effective contraceptive measures;
✓. Understand and voluntarily sign the written informed consent form (ICF), and be willing and capable of undergoing regular visits, treatment plans, laboratory tests, and other trial procedures.
Exclusion criteria
✕. 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;
What they're measuring
1
changes in International Prostatism Symptom Score (IPSS) at 12 weeks from baseline
✕. 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;
✕. Subjects with residual urine volume greater than 100 mL (measured by transabdominal ultrasound) or those for whom catheterization is deemed necessary by the investigator;
✕. Subjects who underwent cystoscopy, other transurethral endoscopic procedures, or therapeutic urinary catheterization within 1 month prior to the screening period;
✕. Subjects with a history of acute urinary retention (AUR) or cystostomy within 3 months prior to the screening period;
✕. Subjects with documented pelvic cavity trauma or urethral surgical interventions;