Prostatic HyperplasiaNCT01003886
A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
An observational study of Prostatic Hyperplasia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 67 sites in Philippines.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Doxazosin mesylate GITS
- How many people
- 989 participants
- Where
- 67 sitesPhilippines
- Study dates
- May 2009to Jan 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with Doxazosin mesylate GITS
Who may be able to join
- 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.
Who cannot join
- Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
Philippines67 sites
Pfizer Investigational Site
Angeles
Pfizer Investigational Site
Angeles City, Pampanga
Pfizer Investigational Site
Angeles City
Pfizer Investigational Site
Bacolod City
Pfizer Investigational Site
Baguio City
Pfizer Investigational Site
Bohol
Pfizer Investigational Site
Bulacan
Pfizer Investigational Site
Butuan, Agusan Del Norte
Pfizer Investigational Site
Butuan
Pfizer Investigational Site
Cagayan de Oro
Pfizer Investigational Site
Cebu
Pfizer Investigational Site
Cebu City, 6000
Pfizer Investigational Site
Cebu City
Pfizer Investigational Site
City of Muntinlupa
Pfizer Investigational Site
City of San Fernando, La Union
Pfizer Investigational Site
Davao City
Pfizer Investigational Site
Diliman, Quezon City, National Capital Region, 1101
Pfizer Investigational Site
Ermita, Manila, 1000
Pfizer Investigational Site
Gallares City
Pfizer Investigational Site
General Santos
Pfizer Investigational Site
Iligan City
Pfizer Investigational Site
Ilocos Norte
Pfizer Investigational Site
Kalibo Aklan
Pfizer Investigational Site
Kalibo Town
Pfizer Investigational Site
La Union
Pfizer Investigational Site
Laguna
Pfizer Investigational Site
Laoag
Pfizer Investigational Site
Lingayen, Pangasinan
Pfizer Investigational Site
Makati City
Pfizer Investigational Site
Malabon
Pfizer Investigational Site
Manadaluyong
Pfizer Investigational Site
Mandaluyong
Pfizer Investigational Site
Mandaue City
Pfizer Investigational Site
Manila, 1000
Pfizer Investigational Site
Manila
Pfizer Investigational Site
Marikina City
Pfizer Investigational Site
Mindanaw
Pfizer Investigational Site
Nueva Ecija
Pfizer Investigational Site
Nueva Vizcaya
Pfizer Investigational Site
Ozamiz
Pfizer Investigational Site
Pampanga
Pfizer Investigational Site
Pasig, National Capital Region, 1605
Pfizer Investigational Site
Pasig
Pfizer Investigational Site
Philippines
Pfizer Investigational Site
Quezon
Pfizer Investigational Site
Quezon City, Diliman
Pfizer Investigational Site
Quezon City, 1100
Pfizer Investigational Site
Quezon City, 1102
Pfizer Investigational Site
Quezon City, 1109
Pfizer Investigational Site
Quezon City
Pfizer Investigational Site
Rizal
Pfizer Investigational Site
San Jose
Pfizer Investigational Site
San Juan City, Batangas
Pfizer Investigational Site
Surigao City
Pfizer Investigational Site
Tacloban City
Pfizer Investigational Site
Tagbilaran City, Bohol
Pfizer Investigational Site
Tagbilaran City, 6300
Pfizer Investigational Site
Tagbilaran City
Pfizer Investigational Site
Tagum
Pfizer Investigational Site
Tarlac City, 2300
Pfizer Investigational Site
Tarlac City
Pfizer Investigational Site
Tondo, Manila, 1000
Pfizer Investigational Site
Tuguegarao City
Pfizer Investigational Site
Valenzuela
Pfizer Investigational Site
Vigan
Pfizer Investigational Site
Visayas
Pfizer Investigational Site
West Fairview, Quezon City, 1100
About this study
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.
Read the detailed description
This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in this study.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Doxazosin mesylate GITS
- Keywords
- post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin mesylate GITSDrug
Also called Alfadil XL
Doxazosin mesylate GITS 4mg to 8mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS Receives: Drug: Doxazosin mesylate GITS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 13 (7 days after last dose)
Secondary outcomes (5)
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.
Measured: Baseline, Week 4 and Week 12
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.
Measured: Baseline, Week 4 and Week 12
Change From Baseline in Systolic BP at Week 4 and Week 12
Values at Week 4 and Week 12 minus value at baseline.
Measured: Baseline through Week 12
Change From Baseline in Diastolic BP at Week 4 and Week 12
Values at Week 4 and Week 12 minus value at baseline.
Measured: Baseline through Week 12
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.
Measured: Baseline up to Week 13 (7 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 989 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003886
- Sponsor's protocol ID
- A0351068
- Status last verified
- Jan 2021
- First submitted
- 28 Oct 2009
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01003886
- Acronym / sponsor ID
- A0351068
- Conditions
- Prostatic Hyperplasia
- Keywords
- post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin GITS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 989 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Posted 28 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | – | Drug: Doxazosin mesylate GITSAdult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with Doxazosin mesylate GITS
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxazosin mesylate GITSAlso: Alfadil XLDoxazosin mesylate GITS 4mg to 8mg once daily | Drug | Open Label |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 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.
5 secondary outcomes
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
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
Change From Baseline in Systolic BP at Week 4 and Week 12
Time frame: Baseline through Week 12
Change From Baseline in Diastolic BP at Week 4 and Week 12
Time frame: Baseline through Week 12
Percentage of Participants With Postural Hypotension
Time frame: Baseline up to Week 13 (7 days after last dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Prostatic Hyperplasia
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Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 67 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Baseline up to Week 13 (7 days after last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.