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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: December 2010

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

• Incidence of adverse events
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Improvement in the International Prostate Symptom score (IPSS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Incidence of postural hypotension
  • Time Frame: 12 weeks
    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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on February 04, 2010

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.