A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care setting.

Detailed Description
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This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in this study.

Official Title
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A Post Marketing Surveillance Study To Determine The Safety, Tolerability And Effectiveness Of Doxazosin Mesylate GITS Among Filipino Adult Males With Benign Prostatic Hyperplasia (BPH)

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Doxazosin mesylate GITS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects that will be included must be consistent with the approved label indication of Doxazosin mesylate GITS in the Philippines, which includes adult male diagnosed with BPH, and who are prescribed with Doxazosin mesylate GITS. Exclusion Criteria: Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Label<br>Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS | Drug: Doxazosin mesylate GITS<br>* Doxazosin mesylate GITS 4mg to 8mg once daily<br>* Other names: Alfadil XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. | Baseline up to Week 13 (7 days after last dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | The IPSS total score is obtained by combining the scores of the responses to 1 through 7 component questions all of which were on a 6 point likert scale. Each question is scored from 0-5 for an IPSS range of 0-35 points where 0 = best possible score to 35 = worst possible score. | Baseline, Week 4 and Week 12 | 
| Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | The IPSS QoL Score is obtained by assessment of a single QoL question on a 7-point likert scale which was scored on a scale of 0-6 where 0 = best possible score to 6 = worst possible score. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Systolic BP at Week 4 and Week 12 | Values at Week 4 and Week 12 minus value at baseline. | Baseline through Week 12 | 
| Change From Baseline in Diastolic BP at Week 4 and Week 12 | Values at Week 4 and Week 12 minus value at baseline. | Baseline through Week 12 | 
| Percentage of Participants With Postural Hypotension | Postural or orthostatic hypotension is a medical condition where blood pressure falls rapidly after the body changes position most commonly occurring after standing up after sitting for long periods of time. | Baseline up to Week 13 (7 days after last dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS