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

NCT07134907 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-08-21

No results posted yet for this study

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. Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？
2. Dose QWT have other advantages in the improvement of LUTS?

Participants will:

1. Orally take QWT twice daily or tamsulosin once daily for 12 weeks.
2. Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.

Conditions

  • BPH (Benign Prostatic Hyperplasia)

Interventions

DRUG

Silodosin

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.

DRUG

Tamsolusin

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.

Sponsors & Collaborators

  • Shanghai Huilun Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shan Chen · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2024-07-09
Completion
2024-07-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134907 on ClinicalTrials.gov