NCT07134907

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

The Efficacy and Safety of Qianweitai (Silodosin Capsule) Compared to Tamsulosin in the Treatment of Benign Prostaic Hyperplasia (BPH) -A Multicenter, Prospecive, Randomized, Investigator-Blind, Positive-Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is designed as two stages: screening period, treatment and follow-up period. Screening period (days -28 to 0): After signing the informed consent form, the subjects entered into the screening period, and made a 24-hour urination diary and screening examination. Treatment and Follow-up period: eligible patients were randomly assigned to 2 groups according to 1: 1 and received Tamsulosin or Silodosin or for 12 weeks. During the treatment period, the subjects' diaries were recorded according to the requirements of the scheme, and they were followed up at 1 week (7±2 days), 2 weeks (14±3), 4 weeks (28±5 days), 8 weeks (56±7 days) and 12 weeks (84±10 days). During the visit, relevant scale scores and laboratory examinations were performed, and the occurrence of adverse events during the follow-up was recorded to evaluate the safety.

Conditions

• BPH (Benign Prostatic Hyperplasia)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-18
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

6 sites across 1 country: China