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

Astellas

Status and phase

Completed

Phase 4

Conditions

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

Treatments

Drug: Tamsulosin OCAS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02180789

HAURO-1201-TW

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed as LUTS associated with BPH
Currently taking oral tamsulosin 0.2 mg for at least 4 weeks
Unsatisfied with the treatment of tamsulosin 0.2 mg The definition of 'unsatisfaction' is based on patient's satisfaction. Investigator will ask patient one question "Are you satisfied with your current treatment?" prior to study enrollment
IPSS-QOL score ≧3 points at baseline

Exclusion criteria

Subjects who underwent prostatectomy during the period of one year prior to this study
Subjects with neurogenic bladder dysfunction, bladder neck sclerosis, urethral stricture, prostatic cancer, cystolithiasis, severe vesical diverticulum, urinary tract infection
Subjects with any other complication which may cause voiding dysfunction
Subjects with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorders, orthostatic hypotension, or senile dementia
Subjects clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
Subjects who are currently participating in any other investigational drug study or who have participated in a study of an investigational drug within 3 months prior to this study