A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
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|ClinicalTrials.gov Identifier: NCT01003886|
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : October 28, 2011
Last Update Posted : October 28, 2011
|Condition or disease||Intervention/treatment|
|Prostatic Hyperplasia||Drug: Doxazosin mesylate GITS|
|Study Type :||Observational|
|Actual Enrollment :||989 participants|
|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 Hyperplasia (BPH)|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS
Drug: Doxazosin mesylate GITS
Doxazosin mesylate GITS 4mg to 8mg once daily
Other Name: Alfadil XL
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003886
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|