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
1 other identifier
interventional
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1 country
66
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2025
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 12, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
August 28, 2025
August 1, 2025
1.4 years
August 12, 2025
August 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in International Prostatism Symptom Score (IPSS) at 12 weeks from baseline
The study set the change in the IPSS of patients after 12 weeks of medication compared to the baseline data as the primary endpoint. The IPSS is currently the internationally recognized best method for assessing the severity of symptoms in patients with benign prostatic hyperplasia. The IPSS scale is used to evaluate the severity of 7 urinary symptoms, namely: incomplete urination, frequent urination, intermittent urine flow, urgency, weak urine stream, difficulty in urination, and nocturia frequency. Each of the 7 symptoms is scored in 6 segments based on the occurrence in the last month (0-5 points, 0 indicates no occurrence, 5 indicates almost always occurring). The total score is 35 points, and the patient's symptoms are classified as mild (0-7 points), moderate (8-19 points), and severe (20-35 points).
baseline to 12 weeks
Secondary Outcomes (9)
changes in IPSS at 1, 2, 4, and 8 weeks from baseline
baseline to 1, 2, 4, and 8 weeks
quality of life (QOL) scores
baseline to 1, 2, 4, 8, and 12 weeks
The proportion of subjects whose IPSS scores changed by ≥ 3 points or improved by ≥ 25% compared to the baseline
baseline to 1, 2, 4, 8, and 12 weeks
maximum urine flow rate (Qmax) changes
baseline to 2, 4, 8, and 12 weeks
The proportion of subjects whose Qmax increased by ≥ 3 ml/s and improved by ≥ 30% compared to the baseline
baseline to 1, 2, 4, 8, and 12 weeks
- +4 more secondary outcomes
Study Arms (2)
H077 treatment group
EXPERIMENTALSubjects 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
ACTIVE COMPARATORSubjects are administered one Silodosin capsule (4 mg) twice daily, along with one H077 sustained-release tablet placebo once daily, orally.
Interventions
Subjects are administered one H077 sustained-release tablet (8 mg) orally once daily, along with one silodosin capsule (placebo) orally twice daily.
Subjects are administered one Silodosin capsule (4 mg) twice daily, along with one H077 sustained-release tablet placebo once daily, orally.
Eligibility Criteria
You may qualify if:
- Male, aged 50 to 75 years old, inclusive of both endpoints;
- Meets the clinical diagnostic criteria for benign prostatic hyperplasia (BPH);
- IPSS score was ≥ 8 points, and the QOL score was ≥ 3 points during the screening period;
- Prostate volume ≥ 20 ml (measured by transabdominal ultrasound);
- PSA≤4 ng/mL;
- During the screening period, Qmax \> 5 ml/s and Qmax \<15 ml/s (urine output ≥ 125 ml);
- 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;
- 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.
You may not qualify if:
- Those who are allergic to any component of α/β-adrenergic receptor blockers or the test drugs; or who have contraindications;
- 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;
- During the screening process, researchers identified patients with BPH who required minimally invasive prostate treatment or surgical intervention;
- 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;
- Subjects with residual urine volume greater than 100 mL (measured by transabdominal ultrasound) or those for whom catheterization is deemed necessary by the investigator;
- Subjects who underwent cystoscopy, other transurethral endoscopic procedures, or therapeutic urinary catheterization within 1 month prior to the screening period;
- Subjects with a history of acute urinary retention (AUR) or cystostomy within 3 months prior to the screening period;
- Subjects with documented pelvic cavity trauma or urethral surgical interventions;
- 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;
- 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;
- 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;
- During the screening period, serum creatinine was greater than 1.5 times the upper limit of the normal range;
- Patients who plan to undergo cataract surgery during the medication period and within 3 months after the medication is completed;
- 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;
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
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
Liuchow, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2025
First Posted
August 28, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share