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

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Doxazosin mesylate GITS

• Registration Number: NCT01003886
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 Description

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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-09-19
• Results First Submitted QC: 2011-09-19
• Results First Posted: 2011-10-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 989

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Label	Doxazosin mesylate GITS	Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12	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	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 Diastolic BP at Week 4 and Week 12	Baseline through Week 12	Values at Week 4 and Week 12 minus value at baseline.
Percentage of Participants With Postural Hypotension	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.
Change From Baseline in Systolic BP at Week 4 and Week 12	Baseline through Week 12	Values at Week 4 and Week 12 minus value at baseline.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇭 West Fairview, Quezon City, Philippines