NCT07146386

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

A Randomized, Double-blind, Controlled, Non-inferiority Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of H077 Sustained-release Tablets Versus Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 728 (estimated)
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia
• Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	H077 sustained-release tablet	Subjects are administered one H077 sustained-release tablet (8 mg) orally once daily, along with one silodosin capsule (placebo) orally twice daily.
DRUG	Silodosin capsules Control Group	Subjects are administered one Silodosin capsule (4 mg) twice daily, along with one H077 sustained-release tablet placebo once daily, orally.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

66 sites across 1 country: China