NCT05422677

An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

An Observational Study to Evaluate the Effectiveness and Safety of the Treatment of Tamsulosin in Korean Adult Males Diagnosed With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,698 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

In this study, BPH patients visited the institutions during the study period and the effectiveness and safety of the treatment of Tamsulosin(Hanmi Tams® Capsule) in real-practice. During the routine medical visit, according to the investigator's judgment, with diagnosis that the Tamsulosin prescription is appropriate, and after deciding to start treatment, patients with BPH who agreed to participate in the study were administered Tamsulosin. As this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Detailed description

This study is a multicenter, prospective, non-interventional, observational study of men administering Tamsulosin(Hanmi Tams® Capsule) to treat BPH. Data will be collected from patients receiving routine treatment at hospitals in South Korea. Each subject visit the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Tamsulosin. This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.

Conditions

• BPH
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Hanmi Tams® Capsule	Hanmi Tams®, Once daily administered per the locally approved product information

Timeline

• Start date: 2019-07-15
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2022-06-16
• Last updated: 2022-06-22

Locations

1 site across 1 country: South Korea