The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH

NCT07134907 | Completed Phase 4

• 1 other identifier: NM-22-A-001-YJ-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are:

1. 1.Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？
2. 2.Dose QWT have other advantages in the improvement of LUTS?
3. 3.Orally take QWT twice daily or tamsulosin once daily for 12 weeks.
4. 4.Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

Benign Prostatic Hyperplasia; Qianweitai; Tamsulosin; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score（IPSS）

  Changes of IPSS scores at the 12th week of treatment compared with baseline scores.

  week 12

Secondary Outcomes (11)

• International Prostate Symptom Score（IPSS） total score

  1, 2, 4 and 8 weeks

• IPSS storage subscore

  1, 2, 4 and 8 weeks

• IPSS voiding subscore

  1, 2, 4 and 8 weeks

• IPSS total score severity

  week 12

• Quality of life (QoL) score

  4, 8 and 12 weeks

Study Arms (2)

Qianweitai

EXPERIMENTAL

Patients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner).

Drug: Silodosin

Tamsulosin

ACTIVE COMPARATOR

Patients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily).

Drug: Tamsolusin

Interventions

Silodosin DRUG

Silodosin is an α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieve the dynamic obstruction of bladder outlet, and improve the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner.

Also known as: Qianweitai

Qianweitai

Tamsolusin DRUG

Tamsulosin is an α1A-adrenergic receptor blocker which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.

Also known as: Harnal

Tamsulosin

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
• Has an IPSS score ≥ 8 points at Screening and Baseline.
• Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume \> 150 ml.
• Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
• Subjects who can read, understand, and complete the research questionnaire.
• Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.

You may not qualify if:

• Subjects with prostate cancer or other malignant tumors.
• Subjects have serum tPSA \> 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA \< 0.16 times.
• Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
• Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.
• Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
• Subjects have residual urine volume (PVR) \> 100ml, or those who may have urinary retention and need catheterization.
• Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
• Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
• Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
• Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
• There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) \> 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L).
• Subjects who are allergic to the drugs or ingredients used in the test definitely.

Sponsors & Collaborators

• Shanghai Huilun Pharmaceutical Co., Ltd.: lead

Study Sites (6)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Wuhan Center Hospital

Wuhan, Hubei, China

Location

Wuhan No.1 Hospital

Wuhan, Hubei, China

Location

The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Ciivil Aviation General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

silodosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shan Chen

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: July 18, 2022
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (6)