drugset / Trial / NCT05551221

The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

NCT05551221 ↗

Phase 4 Completed 110 enrolled Xintian Pharmaceutical
RandomizedParallel-groupTriple-blindTreatment

Summary

Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, investigator-blind, active controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.

Timeline

Start
2022-09-21
Primary completion
2024-09-10
Completion
2024-09-10

Drugs

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