A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia
NCT ID: NCT07146386
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
728 participants
INTERVENTIONAL
2025-08-31
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH
NCT07134907
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
NCT00224107
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
NCT05551221
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
NCT00224120
Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
NCT02106182
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
H077 treatment group
Subjects are administered one H077 sustained-release tablet (8 mg) orally once daily, along with one silodosin capsule (placebo) orally twice daily.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Meets the clinical diagnostic criteria for benign prostatic hyperplasia (BPH);
3. IPSS score was ≥ 8 points, and the QOL score was ≥ 3 points during the screening period;
4. Prostate volume ≥ 20 ml (measured by transabdominal ultrasound);
5. PSA≤4 ng/mL;
6. During the screening period, Qmax \> 5 ml/s and Qmax \<15 ml/s (urine output ≥ 125 ml);
7. 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;
8. 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
2. 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;
3. During the screening process, researchers identified patients with BPH who required minimally invasive prostate treatment or surgical intervention;
4. 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;
5. Subjects with residual urine volume greater than 100 mL (measured by transabdominal ultrasound) or those for whom catheterization is deemed necessary by the investigator;
6. Subjects who underwent cystoscopy, other transurethral endoscopic procedures, or therapeutic urinary catheterization within 1 month prior to the screening period;
7. Subjects with a history of acute urinary retention (AUR) or cystostomy within 3 months prior to the screening period;
8. Subjects with documented pelvic cavity trauma or urethral surgical interventions;
9. During the screening period, any disease other than BPH that the investigator deems could cause urinary symptoms or changes in urine flow rate (such as neurogenic bladder, bladder neck fibrosis, bladder tumor, urinary calculi, urethral stricture, phimosis or penile tumor, acute or chronic prostatitis, acute or chronic urinary tract infection, acute or chronic renal failure, congenital developmental abnormalities of the urinary and reproductive system, etc.) must be excluded;
10. During the screening period, subjects with positive hepatitis B surface antigen (HBsAg) and HBV-DNA levels greater than 500 IU/ml, or with positive hepatitis C virus antibody (HCV-Ab) and HCV-RNA levels greater than 500 IU/ml, or who had received hepatitis-related antiviral drug treatment within 6 months prior to the first administration;
11. During screening period, the levels of aspartate transaminase (AST) or alanine transaminase (ALT) were more than 3 times the upper limit of the normal range;
12. During the screening period, serum creatinine was greater than 1.5 times the upper limit of the normal range;
13. Patients who plan to undergo cataract surgery during the medication period and within 3 months after the medication is completed;
14. Currently or previously have the following diseases or conditions: a) Have a clear history of orthostatic hypotension in the past, or have a positive orthostatic hypotension test; or have a history of malignant hypertension; b) Have recurrent dizziness, vertigo, loss of consciousness or syncope, or any other signs or symptoms that the investigator considers may be worsened by celerodisonic; c) Have undergone major surgery (excluding biopsy) within 4 weeks before screening and have not fully recovered; d) Have had myocardial infarction, unstable angina pectoris, need for clinical intervention or clinical symptoms of arrhythmia, need for clinical intervention or clinical symptoms of congestive heart failure, or any cerebrovascular accident within 6 months before screening; e) Have a previous surgical history or have severe gastrointestinal diseases, which the investigator considers may affect the absorption, distribution, metabolism, etc. of the study drug; f) Have active infectious diseases and require systemic anti-infection treatment; g) Have a history of diabetes and poor blood sugar control, or have patients with diabetic nephropathy that require drug control; h) Have had malignant tumors within 5 years before screening; i) Have patients with other serious primary diseases and functional disorders in the heart, brain, lungs, liver, kidneys, hematopoietic system, endocrine system, etc;
15. Currently or previously used the following drugs: a) Within 3 months before screening or during the study, need to use 5α-reductase inhibitors, anti-androgen drugs, and androgen drugs or any other drugs that affect hormone levels or prostate volume; b) Within 2 weeks before screening or during the study, need to use any α-adrenergic receptor blockers or any α-receptor blockers other than cilorodin during the study; c) Within 4 weeks before screening or during the study, need to use PDE-5 inhibitors, anticholinergic drugs, anticholinergic drugs or any other drugs that affect urinary function; d) Within 2 weeks before screening or during the study, need to use traditional Chinese medicine, Chinese herbs, or botanical preparations with indications for BPH; e) Within 4 weeks before screening or during the study, need to use any CYP3A4 strong inhibitors, CYP3A4 strong inducers or P-gp strong inhibitors;
16. Subjects who participated in other drug or device clinical trials within 3 months prior to screening;
17. Subjects with current alcohol or substance abuse were excluded;
18. The researchers determined that the patient had other circumstances that affected the safety or efficacy assessment of the study drug, the obtaining of informed consent, or the compliance with the study procedures.
50 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Huilun Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second People's Hospital of Hefei
Hefei, Anhui, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Provincial People's Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)
Dongguan, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
First Affiliated Hospital of Hebei University of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
The People's Hospital of Anyang City
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Zhengzhou People's Hospital
Zhengzhou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, China
The Sixth hospital of Wuhan
Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Wuhan Hospital of Traditional Chinese And Western Medicine
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Wuxi People's Hospital affiliated to Nanjing Medical University
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Tongji Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Chengdu Xindu District People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Third People's Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University
Chengdu, Sichuan, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang Uygur Autonomous Region, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Huzhou First People's Hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Fourth Hospital of Zhejiang University School of Medicine
Jinhua, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhaozhao Liang
Role: primary
Yanbin Zhang
Role: primary
Hao Ping
Role: primary
Weiyang He
Role: primary
Yi Zhang
Role: primary
Yong Wei
Role: primary
Jinchun Xing
Role: primary
Haili Lin
Role: primary
Jiexin Luo
Role: primary
Junhong Zheng
Role: primary
Hongtao Jiang
Role: primary
Siping Zeng
Role: primary
Jiwen Cheng
Role: primary
Yanfeng Li
Role: primary
Guobiao Liang
Role: primary
Yongzhang Li
Role: primary
Haifang Zhang
Role: primary
Jianguo Zhang
Role: primary
Jun Li
Role: primary
Kai Zhang
Role: primary
Qianhe Han
Role: primary
Jian Li
Role: primary
Dengpan Fang
Role: primary
Zhong Chen
Role: primary
Jingdong Yuan
Role: primary
Junfeng Yu
Role: primary
Fajun Fu
Role: primary
Mingyong Li
Role: primary
Dong Xue
Role: primary
Yan Xu
Role: primary
Ruipeng Jia
Role: primary
Jianlin Lv
Role: primary
Jian Zhang
Role: primary
Conghui Han
Role: primary
Xuefei Ding
Role: primary
Chuance Du
Role: primary
Quan Zeng
Role: primary
Jingen Wang
Role: primary
Jianbin Bi
Role: primary
Yi Sun
Role: primary
Wei Zheng
Role: primary
Qiang Fu
Role: primary
Zhanpeng Lu
Role: primary
Lei Chen
Role: primary
Denglong Wu
Role: primary
Feng Chang
Role: primary
Gengyan Xiong
Role: primary
Xiaoke Huang
Role: primary
Jing Liu
Role: primary
Hui Zhuo
Role: primary
Qian Liu
Role: primary
Xiaodong Li
Role: primary
Changxing Ke
Role: primary
Huadong He
Role: primary
Yubing Li
Role: primary
Zhihui Xu
Role: primary
Rongjiang Wang
Role: primary
Yi He
Role: primary
Yichun Zheng
Role: primary
Jie Li
Role: primary
Rubing Li
Role: primary
Zejun Yan
Role: primary
Jiajun Yan
Role: primary
Mang Ke
Role: primary
Wei Chen
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PH-H077-III-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.