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

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)”

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.

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

Intervention(s) in this Clinical Trial

• Drug: Doxazosin mesylate GITS
  • Doxazosin mesylate GITS 4mg to 8mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• : Open Label
  • Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS

Primary Measures

• Number of Participants With Adverse Events (AEs)
  • Time Frame: Baseline up to Week 13 (7 days after last dose)
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline in Systolic BP at Week 4 and Week 12
  • Time Frame: Baseline through Week 12
    Safety Issue?: Yes
• Change From Baseline in Diastolic BP at Week 4 and Week 12
  • Time Frame: Baseline through Week 12
    Safety Issue?: Yes
• Percentage of Participants With Postural Hypotension
  • Time Frame: Baseline up to Week 13 (7 days after last dose)
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01003886

Study ID Number: A0351068

ClinicalTrials.gov Identifier: NCT01003886

Health Authority: Philippines: Bureau of Food and Drugs

To obtain contact information for a study center near you, click here.