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NCT01003886 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01003886
Other study ID # A0351068
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2009
Est. completion date January 2011

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 989
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Philippines Pfizer Investigational Site Angeles
Philippines Pfizer Investigational Site Angeles City Pampanga
Philippines Pfizer Investigational Site Angeles City
Philippines Pfizer Investigational Site Bacolod City
Philippines Pfizer Investigational Site Baguio City
Philippines Pfizer Investigational Site Bohol
Philippines Pfizer Investigational Site Bulacan
Philippines Pfizer Investigational Site Butuan City
Philippines Pfizer Investigational Site Butuan City Agusan Del Norte
Philippines Pfizer Investigational Site Cagayan De Oro City
Philippines Pfizer Investigational Site Cebu
Philippines Pfizer Investigational Site Cebu City
Philippines Pfizer Investigational Site Cebu City
Philippines Pfizer Investigational Site City Of San Fernando La Union
Philippines Pfizer Investigational Site Davao
Philippines Pfizer Investigational Site Davao City
Philippines Pfizer Investigational Site Diliman, Quezon City Metro Manila
Philippines Pfizer Investigational Site Ermita Manila
Philippines Pfizer Investigational Site Gallares City
Philippines Pfizer Investigational Site General Santos City
Philippines Pfizer Investigational Site Iligan City
Philippines Pfizer Investigational Site Ilocos Norte
Philippines Pfizer Investigational Site Kalibo
Philippines Pfizer Investigational Site Kalibo Aklan
Philippines Pfizer Investigational Site La Union
Philippines Pfizer Investigational Site Laguna
Philippines Pfizer Investigational Site Laoag City
Philippines Pfizer Investigational Site Lingayen, Pangasinan
Philippines Pfizer Investigational Site Makati City
Philippines Pfizer Investigational Site Malabon City
Philippines Pfizer Investigational Site Manadaluyong
Philippines Pfizer Investigational Site Mandaluyong
Philippines Pfizer Investigational Site Mandaluyong City
Philippines Pfizer Investigational Site Mandaue City
Philippines Pfizer Investigational Site Manila
Philippines Pfizer Investigational Site Manila
Philippines Pfizer Investigational Site Marikina
Philippines Pfizer Investigational Site Marikina City
Philippines Pfizer Investigational Site Mindanao
Philippines Pfizer Investigational Site Muntinlupa
Philippines Pfizer Investigational Site Nueva Ecija
Philippines Pfizer Investigational Site Nueva Vizcaya
Philippines Pfizer Investigational Site Ozamis City
Philippines Pfizer Investigational Site Ozamiz City
Philippines Pfizer Investigational Site Pampanga
Philippines Pfizer Investigational Site Pasig City
Philippines Pfizer Investigational Site Pasig City Metro Manila
Philippines Pfizer Investigational Site Philippines
Philippines Pfizer Investigational Site Quezon
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City Diliman
Philippines Pfizer Investigational Site Rizal
Philippines Pfizer Investigational Site San Jose City
Philippines Pfizer Investigational Site San Juan Batangas
Philippines Pfizer Investigational Site Surigao City
Philippines Pfizer Investigational Site Tacloban
Philippines Pfizer Investigational Site Tacloban City
Philippines Pfizer Investigational Site Tagbilaran City
Philippines Pfizer Investigational Site Tagbilaran City
Philippines Pfizer Investigational Site Tagbilaran City Bohol
Philippines Pfizer Investigational Site Tagum City
Philippines Pfizer Investigational Site Tarlac
Philippines Pfizer Investigational Site Tarlac City
Philippines Pfizer Investigational Site Tarlac City
Philippines Pfizer Investigational Site Tondo Manila
Philippines Pfizer Investigational Site Tuguegarao City
Philippines Pfizer Investigational Site Valenzuela City
Philippines Pfizer Investigational Site Vigan
Philippines Pfizer Investigational Site Visayas
Philippines Pfizer Investigational Site West Fairview, Quezon City

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Baseline up to Week 13 (7 days after last dose)
Secondary Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at 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. Baseline, Week 4 and Week 12
Secondary Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at 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. Baseline, Week 4 and Week 12
Secondary Change From Baseline in Systolic BP at Week 4 and Week 12 Values at Week 4 and Week 12 minus value at baseline. Baseline through Week 12
Secondary Change From Baseline in Diastolic BP at Week 4 and Week 12 Values at Week 4 and Week 12 minus value at baseline. Baseline through Week 12
Secondary Percentage of Participants With Postural Hypotension 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. Baseline up to Week 13 (7 days after last dose)
See also
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Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
Completed NCT02715401 - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers Phase 1
Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
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Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
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Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
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