DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Intervention: Tamsulosin OCAS (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

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).

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes from baseline in total scores of International Prostate Symptom Score (IPSS)

Secondary outcome:

Changes from baseline in IPSS subscore

Changes from baseline in total scores of Quality of life (QOL) index (IPSS-QOL)

Changes from baseline in Uroflowmetry parameters

Changes from baseline in Visual Analogue Scale (VAS)

Safety assessed by the adverse events, physical examination, vital signs and post void residual volume

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.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

Linkou, Taiwan; Recruiting
Additional Information

Starting date: March 2013
Last updated: July 1, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017