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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• changes in International Prostatism Symptom Score (IPSS) at 12 weeks from baseline [Срок оценки: baseline to 12 weeks]

Вторичные конечные точки (9)

• changes in IPSS at 1, 2, 4, and 8 weeks from baseline [Срок оценки: baseline to 1, 2, 4, and 8 weeks]
• quality of life (QOL) scores [Срок оценки: 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 [Срок оценки: baseline to 1, 2, 4, 8, and 12 weeks]
• maximum urine flow rate (Qmax) changes [Срок оценки: 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 [Срок оценки: baseline to 1, 2, 4, 8, and 12 weeks]
• The incidence of acute urinary retention (AUR) during medication administration [Срок оценки: baseline to 12 weeks]
• The incidence of BPH-related surgical treatment. [Срок оценки: baseline to 12 weeks]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: baseline to 13 weeks]
• Multiple-dose exposure-response relationship [Срок оценки: baseline to 1, 2, 4, 8, and 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 66 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• The Second People's Hospital of Hefei — Хэфэй
• Beijing Tongren Hospital Affiliated to Capital Medical University — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Fujian Provincial People's Hospital — Фучжоу
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• The First Affiliated Hospital of Xiamen University — Xiamen
• Zhangzhou Affiliated Hospital of Fujian Medical University — Zhangzhou
• … и ещё 58 центров

Идентификаторы

NCT: NCT07146386 · PH-H077-III-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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