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) ]

Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.


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