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COMPLETED
NCT05551221
PHASE4

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

Sponsor: Xintian Pharmaceutical

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study

Key Details

Gender

MALE

Age Range

60 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2022-07-18

Completion Date

2024-09-10

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

Silodosin Capsules

Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves 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

Tamsulosin

Tamsulosin is α1A-adrenergic receptor 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.

Locations (8)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The Central Hospital Of WUHAN

Wuhan, Hubei, China

Wuhan No.1 Hospital

Wuhan, Hubei, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China