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

Phase 3 Not yet recruiting 728 enrolled Shanghai Huilun Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2025-08
Primary completion: 2027-01
Completion: 2027-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	H077	Unknown	8 mg	Oral
Comparator	Silodosin	Unknown	4 mg	Oral

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

Summary

Timeline

Drugs

Indications