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Benign Prostatic HyperplasiaPhase 3NCT07146386

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

A Phase 3 study testing H077 sustained-release tablet in people with Benign Prostatic Hyperplasia and Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Shanghai Huilun Pharmaceutical Co., Ltd. at 66 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years, men only
What is being tested?
H077 sustained-release tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
728 participants
Where
66 sitesChina
Study dates
Aug 2025to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 18Show fewer
  • 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;
  • Subjects who participated in other drug or device clinical trials within 3 months prior to screening;
  • Subjects with current alcohol or substance abuse were excluded;
  • 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.

Trial locations and contacts

66 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chao Yun contact

86-021-64311017

yun_chao@hllife.com.cn

66 sites in 1 country

China66 sites

  • The People's Hospital of Anyang City

    Anyang, Henan

    Haifang Zhang

    Haifang Zhang

  • Beijing Tongren Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality

    Hao Ping

    Hao Ping

  • Changsha Central Hospital

    Changsha, Hunan

    Fajun Fu

    Fajun Fu

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi

    Feng Chang

    Feng Chang

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu

    Dong Xue

    Dong Xue

  • Chengdu Xindu District People's Hospital

    Chengdu, Sichuan

    Xiaoke Huang

    Xiaoke Huang

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    Jing Liu

    Jing Liu

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

    Chengdu, Sichuan

    Hui Zhuo

    Hui Zhuo

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Weiyang He

    Weiyang He

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

    Dongguan, Guangdong

    Jiexin Luo

    Jiexin Luo

  • Fujian Provincial People's Hospital

    Fuzhou, Fujian

    Yi Zhang

    Yi Zhang

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Yong Wei

    Yong Wei

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi

    Chuance Du

    Chuance Du

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Yanfeng Li

    Yanfeng Li

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

    Huadong He

    Huadong He

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Liping Xie, 86-0571-87236832, xielp@zju.edu.cn

    Liping Xie

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang

    Yubing Li

    Yubing Li

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Zhihui Xu

    Zhihui Xu

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Zhaozhao Liang

    Zhaozhao Liang

  • The Second People's Hospital of Hefei

    Hefei, Anhui

    Yanbin Zhang

    Yanbin Zhang

  • The First Affiliated Hospital of Nanhua University

    Hengyang, Hunan

    Mingyong Li

    Mingyong Li

  • Huzhou First People's Hospital

    Huzhou, Zhejiang

    Rongjiang Wang

    Rongjiang Wang

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

    Yi He

    Yi He

  • Shandong Provincial Hospital

    Jinan, Shandong

    Qiang Fu

    Qiang Fu

  • The Fourth Hospital of Zhejiang University School of Medicine

    Jinhua, Zhejiang

    Yichun Zheng

    Yichun Zheng

  • Jining First People's Hospital

    Jining, Shandong

    Zhanpeng Lu

    Zhanpeng Lu

  • Affiliated Hospital of Jiujiang University

    Jiujiang, Jiangxi

    Quan Zeng

    Quan Zeng

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Changxing Ke

    Changxing Ke

  • Lishui Central Hospital

    Lishui, Zhejiang

    Jie Li

    Jie Li

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi

    Siping Zeng

    Siping Zeng

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan

    Jianguo Zhang

    Jianguo Zhang

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

    Jingen Wang

    Jingen Wang

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu

    Yan Xu

    Yan Xu

  • Nanjing First Hospital

    Nanjing, Jiangsu

    Ruipeng Jia

    Ruipeng Jia

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu

    Jianlin Lv

    Jian Lv

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Jiwen Cheng

    Jiwen Cheng

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    Rubing Li

    Rubing Li

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Zejun Yan

    Zejun Yan

  • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

    Lei Chen

    Lei Chen

  • Tongji Hospital, School of Medicine, Tongji University

    Shanghai, Shanghai Municipality

    Denglong Wu

    Denglong Wu

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong

    Junhong Zheng

    Junhong Zheng

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang

    Jiajun Yan

    Jiajun Yan

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Jianbin Bi

    Jianbin Bi

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Hongtao Jiang

    Hongtao Jiang

  • First Affiliated Hospital of Hebei University of Traditional Chinese Medicine

    Shijiazhuang, Hebei

    Yongzhang Li

    Yongzhang Li

  • Taiyuan Central Hospital

    Taiyuan, Shanxi

    Gengyan Xiong

    Gengyan Xiong

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Mang Ke

    Mang Ke

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality

    Qian Liu

    Qian Liu

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Wei Chen

    Wei Chen

  • The Sixth hospital of Wuhan

    Wuhan, Hubei

    Dengpan Fang

    Dengpan Fang

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

    Wuhan, Hubei

    Zhong Chen

    Zhong Chen

  • Wuhan Hospital of Traditional Chinese And Western Medicine

    Wuhan, Hubei

    Jingdong Yuan

    Jingdong Yuan

  • Wuxi People's Hospital affiliated to Nanjing Medical University

    Wuxi, Jiangsu

    Jian Zhang

    Jian Zhang

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi

    Yi Sun

    Yi Sun

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Jinchun Xing

    Jinchun Xing

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi

    Wei Zheng

    Wei Zheng

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Xinjiang Uygur Autonomous Region

    Xiaodong Li

    Xiaodong Li

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

    Jun Li

    Jun Li

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

    Conghui Han

    Conghui Han

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

    Xuefei Ding

    Xuefei Ding

  • Yichang Central People's Hospital

    Yichang, Hubei

    Junfeng Yu

    Junfeng Yu

  • Zhangzhou Affiliated Hospital of Fujian Medical University

    Zhangzhou, Fujian

    Haili Lin

    Haili Lin

  • Zhengzhou Central Hospital

    Zhengzhou, Henan

    Kai Zhang

    Kai Zhang

  • Zhengzhou People's Hospital

    Zhengzhou, Henan

    Qianhe Han

    Qianhe Han

  • Zhoukou Central Hospital

    Zhoukou, Henan

    Jian Li

    Jian Li

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

    Guobiao Liang

    Guobiao Liang

Other trials in China

About this study

Official title: 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

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.

Being tested
H077 sustained-release tablet, Silodosin capsules Control Group
Keywords
Benign prostatic hyperplasia, lower urinary tract symptoms, Silodosin, selective α1A-adrenergic receptor blocker, IPSS scores
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H077 sustained-release tabletDrug

    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 GroupDrug

    Subjects are administered one Silodosin capsule (4 mg) twice daily, along with one H077 sustained-release tablet placebo once daily, orally.

Study groups in NCT07146386
Study groupRoleWhat they receive
H077 treatment groupExperimentalSubjects are administered one H077 sustained-release tablet (8 mg) orally once daily, along with one silodosin capsule (placebo) orally twice daily.
Receives: Drug: H077 sustained-release tablet
Silodosin capsules Control GroupActive comparatorSubjects are administered one Silodosin capsule (4 mg) twice daily, along with one H077 sustained-release tablet placebo once daily, orally.
Receives: Drug: Silodosin capsules Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline to 12 weeks

Secondary outcomes (9)

  1. changes in IPSS at 1, 2, 4, and 8 weeks from baseline

    The changes in the IPSS compared to the baseline after 1, 2, 4, and 8 weeks of medication administration.

    Measured: baseline to 1, 2, 4, and 8 weeks

  2. quality of life (QOL) scores

    The QOL score is used to understand the patient's subjective perception of their current level of lower urinary tract symptoms throughout their lifetime. It mainly focuses on the extent to which BPH patients are troubled by lower urinary tract symptoms and whether they can tolerate it. Based on subjective feelings, it is classified as: happy, satisfied, generally satisfied, acceptable, not very satisfied, distressed, and very bad. The scores range from 0 to 6.

    Measured: baseline to 1, 2, 4, 8, and 12 weeks

  3. The proportion of subjects whose IPSS scores changed by ≥ 3 points or improved by ≥ 25% compared to the baseline

    The proportion of subjects whose IPSS scores changed by ≥ 3 points or improved by ≥ 25% compared to the baseline after 1, 2, 4, 8, and 12 weeks of medication administration.

    Measured: baseline to 1, 2, 4, 8, and 12 weeks

  4. maximum urine flow rate (Qmax) changes

    The changes in the maximum urine flow rate (Qmax) compared to the baseline after 2, 4, 8, and 12 weeks of medication administration.

    Measured: baseline to 2, 4, 8, and 12 weeks

  5. The proportion of subjects whose Qmax increased by ≥ 3 ml/s and improved by ≥ 30% compared to the baseline

    The proportion of subjects whose Qmax increased by ≥ 3 ml/s and improved by ≥ 30% compared to the baseline after 1, 2, 4, 8, and 12 weeks of medication administration.

    Measured: baseline to 1, 2, 4, 8, and 12 weeks

  6. The incidence of acute urinary retention (AUR) during medication administration

    The incidence of acute urinary retention (AUR) during medication administration

    Measured: baseline to 12 weeks

  7. The incidence of BPH-related surgical treatment.

    The proportion of participants who discontinued the study treatment during the medication period due to the need for BPH-related surgical treatment.

    Measured: baseline to 12 weeks

  8. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and laboratory test results, etc.

    Measured: baseline to 13 weeks

  9. Multiple-dose exposure-response relationship

    Trough plasma concentrations will be measured after multiple oral doses of H077 sustained-release tablets in BPH subjects. Individual systemic exposure will be predicted from trough concentrations and subsequently utilized for exposure-response analysis.

    Measured: baseline to 1, 2, 4, 8, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a multicenter, randomized, double-blind, controlled non-inferiority phase III study, evaluating the efficacy and safety of H077 sustained-release tablets compared with silodosin capsules in the treatment of benign prostatic hyperplasia (BPH).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
728 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07146386
Sponsor's protocol ID
PH-H077-III-01
Status last verified
Aug 2025
First submitted
12 Aug 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing H077 sustained-release tablet in people with Benign Prostatic Hyperplasia and Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Shanghai Huilun Pharmaceutical Co., Ltd. at 66 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Yun (86-021-64311017, yun_chao@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in International Prostatism Symptom Score (IPSS) at 12 weeks from baseline (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07146386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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