An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422677
• Other study ID #: HM-TAM-OS-02
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: August 24, 2021

Study information

• Verified date: June 2022
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4698
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Male was diagnosed with Benign Prostatic Hyperplasia

• Those who first started taking Hanmi Tams®

• Those who voluntarily consented in writing to this study

Exclusion Criteria:

• Patients for whom use of Hanmi Tams® is prohibited

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• BPH
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Hanmi Tams® Capsule
Hanmi Tams®, Once daily administered per the locally approved product information

Locations

Country	Name	City	State
Korea, Republic of	Hanmi Pharmaceutical Company Limited	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LUTS (Lower Tract Symptoms) improvement effect evaluated in patients with BPH symptoms after Tamsulosin treatment	To measure the level of LUTS (Lower Tract Symptoms), the IPSS was calculated.; : The International Prostate Symptom Score (IPSS) is used to assess the severity of LUTS (Lower Tract Symptoms) and to monitor disease progression.; The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more).; The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.	6 months