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

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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

NCT07146386•Shanghai Huilun Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male, aged 50 to 75 years old, inclusive of both endpoints;
•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

•1. Those who are allergic to any component of α/β-adrenergic receptor blockers or the test drugs; or who have contraindications;
•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;
+8 more criteria

Locations (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

Key Dates

Start Date

August 1, 2025

Primary Completion Date

January 1, 2027

Completion Date

March 1, 2027

Last Updated

August 28, 2025

Enrollment

728

ESTIMATED participants

Conditions

Benign Prostatic HyperplasiaBenign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Interventions

H077 sustained-release tablet

DRUG

Silodosin capsules Control Group

DRUG

Contacts

Chao Yun

CONTACT

86-021-64311017 yun_chao@hllife.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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