NCT02180789

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

Completed Phase 4 Last updated 17 November 2015

What this trial tests

Phase 4 trial testing Tamsulosin OCAS in Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in 100 participants. Completed in 1 January 2015.

Timeline

1 March 2013

Primary endpoint
1 January 2015

1 January 2015

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 March 2013
Primary completion	1 January 2015
Estimated completion	1 January 2015
Sites	1 location across Taiwan

Drugs / interventions tested

• Tamsulosin OCAS — full drug profile →

Conditions studied

• Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) — all drugs for Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

45 and older, male only, with Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes from baseline in total scores of International Prostate Symptom Score (IPSS)
  Time frame: baseline, 4-week, 8-week, 12 week

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An open-label, prospective interventional study of the tolerability and efficacy of 0.4 mg oral tamsulosin oral controlled absorption system in men with lower urinary tract symptoms associated with benign prostatic hyperplasia who are unsatisfied with treatment with 0.2 mg tamsul
   Yang PS, Chen CL, Hou CP, Lin YH, et al · · 2018 · cited 4× · PMID 29445269 · DOI 10.2147/cia.s152701