NCT02180789

A Study to Evaluate the Tolerability and Efficacy of Tamsulosin 0.4mg OCAS Formulation in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2mg Conventional Formulation

An Open-label, Prospective Interventional Study of the Tolerability and Efficacy of Oral Harnalidge® OCAS® (Tamsulosin) 0.4 mg in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2 mg

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, prospective interventional study to assess the tolerability and efficacy of Harnalidge® OCAS® 0.4 mg in Taiwan patients who are unsatisfied with tamsulosin 0.2 mg for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Detailed description

After obtaining informed consent, subjects who meet the inclusion criteria and not violating the exclusion criteria will be enrolled to receive Harnalidge® OCAS® 0.4 mg for treatment. The interventional period for the study is three months after the first date of enrollment or until the patients are discontinued the treatment of Harnalidge® OCAS®. All subjects will be instructed to contact the site if a patient's partner becomes pregnant during or within 90 days from the discontinuation of dosing, the investigator should report the information to the sponsor as if it is an SAE.

Conditions

• Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DRUG	Tamsulosin OCAS	oral

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-07-03
• Last updated: 2015-11-18

Locations

1 site across 1 country: Taiwan