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An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

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Hanmi Pharmaceutical

Status

Completed

Conditions

Benign Prostatic Hyperplasia
BPH

Treatments

Drug: Hanmi Tams® Capsule

Study type

Observational

Funder types

Industry

Identifiers

NCT05422677
HM-TAM-OS-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,698 patients

Sex

Male

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

4,698 participants in 1 patient group

single arm, single group(No interventional)
Description:
Observational
Treatment:
Drug: Hanmi Tams® Capsule

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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