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 subscoreChanges 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
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