Clinical Trial: A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Post Marketing Surveillance Study To Determine The Safety, Tolerability And Effectiveness Of Doxazosin Mesylate GITS Among Filipino Adult Males With Benign Prostatic Hyperplasi
Brief Summary: 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 Summary: This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in this study.
Sponsor: Pfizer
Current Primary Outcome: Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 13 (7 days after last dose) ]
Original Primary Outcome: Incidence of adverse events [ Time Frame: 12 weeks ]
Current Secondary Outcome:
- Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 [ Time Frame: Baseline, 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.
- Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 [ Time Frame: Baseline, 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.
- Change From Baseline in Systolic BP at Week 4 and Week 12 [ Time Frame: Baseline through Week 12 ]Values at Week 4 and Week 12 minus value at baseline.
- Change From Baseline in Diastolic BP at Week 4 and Week 12 [ Time Frame: Baseline through Week 12 ]Values at Week 4 and Week 12 minus value at baseline.
- Percentage of Participants With Postural Hypotension [ Time Frame: Baseline up to Week 13 (7 days after last dose) ]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.
Original Secondary Outcome:
- Improvement in the International Prostate Symptom score (IPSS) [ Time Frame: 12 weeks ]
- Incidence of postural hypotension [ Time Frame: 12 weeks ]
Information By: Pfizer
Dates:
Date Received: October 28, 2009
Date Started: May 2009
Date Completion:
Last Updated: September 19, 2011
Last Verified: September 2011