Clinical Trial

A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia

Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07146386
Lead Sponsor Shanghai Huilun Pharmaceutical Co., Ltd.
Conditions Benign Prostatic Hyperplasia, Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Enrollment 728 participants
Start Date 2025-08
Primary Completion 2027-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2025-08-28