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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

728

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

March 31, 2027

Conditions
Benign Prostatic HyperplasiaBenign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Interventions
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.

Trial Locations (66)

Unknown

The First Affiliated Hospital of Anhui Medical University, Hefei

The Second People's Hospital of Hefei, Hefei

Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing

The First Affiliated Hospital of Chongqing Medical University, Chongqing

Fujian Provincial People's Hospital, Fuzhou

The First Affiliated Hospital of Fujian Medical University, Fuzhou

The First Affiliated Hospital of Xiamen University, Xiamen

Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou

The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital), Dongguan

The Second Affiliated Hospital of Shantou University Medical College, Shantou

Shenzhen People's Hospital, Shenzhen

Liuzhou Worker's Hospital, Liuzhou

The First Affiliated Hospital of Guangxi Medical University, Nanning

The Affiliated Hospital of Guizhou Medical University, Guiyang

Affiliated Hospital of Zunyi Medical University, Zunyi

First Affiliated Hospital of Hebei University of Traditional Chinese Medicine, Shijiazhuang

The People's Hospital of Anyang City, Anyang

The First Affiliated Hospital of Henan University of Science & Technology, Luoyang

The Third Affiliated Hospital of Xinxiang Medical University, Xinxiang

Zhengzhou Central Hospital, Zhengzhou

Zhengzhou People's Hospital, Zhengzhou

Zhoukou Central Hospital, Zhoukou

The Sixth hospital of Wuhan, Wuhan

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan

Wuhan Hospital of Traditional Chinese And Western Medicine, Wuhan

Yichang Central People's Hospital, Yichang

Changsha Central Hospital, Changsha

The First Affiliated Hospital of Nanhua University, Hengyang

The First People's Hospital of Changzhou, Changzhou

Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing

Nanjing First Hospital, Nanjing

Nanjing Jiangning Hospital, Nanjing

Wuxi People's Hospital affiliated to Nanjing Medical University, Wuxi

Xuzhou Central Hospital, Xuzhou

Northern Jiangsu People's Hospital, Yangzhou

Ganzhou People's Hospital, Ganzhou

Affiliated Hospital of Jiujiang University, Jiujiang

Jiangxi Provincial People's Hospital, Nanchang

The First Affiliated Hospital of China Medical University, Shenyang

Shaanxi Provincial People's Hospital, Xi'an

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang

Shandong Provincial Hospital, Jinan

Jining First People's Hospital, Jining

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai

Tongji Hospital, School of Medicine, Tongji University, Shanghai

Heping Hospital Affiliated to Changzhi Medical College, Changzhi

Taiyuan Central Hospital, Taiyuan

Chengdu Xindu District People's Hospital, Chengdu

Sichuan Provincial People's Hospital, Chengdu

The Third People's Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University, Chengdu

Tianjin First Central Hospital, Tianjin

The First Affiliated Hospital of Xinjiang Medical University, Xinjiang

The Second Affiliated Hospital of Kunming Medical University, Kunming

Hangzhou First People's Hospital, Hangzhou

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou

Zhejiang Provincial People's Hospital, Hangzhou

Huzhou First People's Hospital, Huzhou

The First Hospital of Jiaxing, Jiaxing

The Fourth Hospital of Zhejiang University School of Medicine, Jinhua

Lishui Central Hospital, Lishui

Ningbo Medical Center Lihuili Hospital, Ningbo

The First Affiliated Hospital of Ningbo University, Ningbo

Shaoxing People's Hospital, Shaoxing

Taizhou Hospital of Zhejiang Province, Taizhou

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

All Listed Sponsors
lead

Shanghai Huilun Pharmaceutical Co., Ltd.

INDUSTRY