Clinical trial NCT01003886: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Keywords: post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 989
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with Doxazosin mesylate GITS

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 13 (7 days after last dose)
Secondary outcomes:
measure: Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Systolic BP at Week 4 and Week 12
timeFrame: Baseline through Week 12
measure: Change From Baseline in Diastolic BP at Week 4 and Week 12
timeFrame: Baseline through Week 12
measure: Percentage of Participants With Postural Hypotension
timeFrame: Baseline up to Week 13 (7 days after last dose)
Other outcomes:
Locations:
city: Butuan City
country: Philippines
facility: Pfizer Investigational Site
state: Agusan Del Norte
city: San Juan
country: Philippines
facility: Pfizer Investigational Site
state: Batangas
city: Tagbilaran City
country: Philippines
facility: Pfizer Investigational Site
state: Bohol
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
state: Diliman
city: City Of San Fernando
country: Philippines
facility: Pfizer Investigational Site
state: La Union
city: Ermita
country: Philippines
facility: Pfizer Investigational Site
state: Manila
city: Tondo
country: Philippines
facility: Pfizer Investigational Site
state: Manila
city: Diliman, Quezon City
country: Philippines
facility: Pfizer Investigational Site
state: Metro Manila
city: Pasig City
country: Philippines
facility: Pfizer Investigational Site
state: Metro Manila
city: Angeles City
country: Philippines
facility: Pfizer Investigational Site
state: Pampanga
city: Angeles City
country: Philippines
facility: Pfizer Investigational Site
city: Angeles
country: Philippines
facility: Pfizer Investigational Site
city: Bacolod City
country: Philippines
facility: Pfizer Investigational Site
city: Baguio City
country: Philippines
facility: Pfizer Investigational Site
city: Bohol
country: Philippines
facility: Pfizer Investigational Site
city: Bulacan
country: Philippines
facility: Pfizer Investigational Site
city: Butuan City
country: Philippines
facility: Pfizer Investigational Site
city: Cagayan De Oro City
country: Philippines
facility: Pfizer Investigational Site
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
city: Cebu
country: Philippines
facility: Pfizer Investigational Site
city: Davao City
country: Philippines
facility: Pfizer Investigational Site
city: Davao
country: Philippines
facility: Pfizer Investigational Site
city: Gallares City
country: Philippines
facility: Pfizer Investigational Site
city: General Santos City
country: Philippines
facility: Pfizer Investigational Site
city: Iligan City
country: Philippines
facility: Pfizer Investigational Site
city: Ilocos Norte
country: Philippines
facility: Pfizer Investigational Site
city: Kalibo Aklan
country: Philippines
facility: Pfizer Investigational Site
city: Kalibo
country: Philippines
facility: Pfizer Investigational Site
city: La Union
country: Philippines
facility: Pfizer Investigational Site
city: Laguna
country: Philippines
facility: Pfizer Investigational Site
city: Laoag City
country: Philippines
facility: Pfizer Investigational Site
city: Lingayen, Pangasinan
country: Philippines
facility: Pfizer Investigational Site
city: Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Malabon City
country: Philippines
facility: Pfizer Investigational Site
city: Manadaluyong
country: Philippines
facility: Pfizer Investigational Site
city: Mandaluyong City
country: Philippines
facility: Pfizer Investigational Site
city: Mandaluyong
country: Philippines
facility: Pfizer Investigational Site
city: Mandaue City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Marikina City
country: Philippines
facility: Pfizer Investigational Site
city: Marikina
country: Philippines
facility: Pfizer Investigational Site
city: Mindanao
country: Philippines
facility: Pfizer Investigational Site
city: Muntinlupa
country: Philippines
facility: Pfizer Investigational Site
city: Nueva Ecija
country: Philippines
facility: Pfizer Investigational Site
city: Nueva Vizcaya
country: Philippines
facility: Pfizer Investigational Site
city: Ozamis City
country: Philippines
facility: Pfizer Investigational Site
city: Ozamiz City
country: Philippines
facility: Pfizer Investigational Site
city: Pampanga
country: Philippines
facility: Pfizer Investigational Site
city: Pasig City
country: Philippines
facility: Pfizer Investigational Site
city: Philippines
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon
country: Philippines
facility: Pfizer Investigational Site
city: Rizal
country: Philippines
facility: Pfizer Investigational Site
city: San Jose City
country: Philippines
facility: Pfizer Investigational Site
city: Surigao City
country: Philippines
facility: Pfizer Investigational Site
city: Tacloban City
country: Philippines
facility: Pfizer Investigational Site
city: Tacloban
country: Philippines
facility: Pfizer Investigational Site
city: Tagbilaran City
country: Philippines
facility: Pfizer Investigational Site
city: Tagbilaran City
country: Philippines
facility: Pfizer Investigational Site
city: Tagum City
country: Philippines
facility: Pfizer Investigational Site
city: Tarlac City
country: Philippines
facility: Pfizer Investigational Site
city: Tarlac City
country: Philippines
facility: Pfizer Investigational Site
city: Tarlac
country: Philippines
facility: Pfizer Investigational Site
city: Tuguegarao City
country: Philippines
facility: Pfizer Investigational Site
city: Valenzuela City
country: Philippines
facility: Pfizer Investigational Site
city: Vigan
country: Philippines
facility: Pfizer Investigational Site
city: Visayas
country: Philippines
facility: Pfizer Investigational Site
city: West Fairview, Quezon City
country: Philippines
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: