drugset / Trial / NCT07134907

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

NCT07134907

Phase 4 Completed 110 enrolled Shanghai Huilun Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Silodosin Unknown 4 mg Oral
Comparator Tamsulosin Other / unclassified Oral