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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
989

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Angeles, 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
      • Cagayan De Oro City, Philippines
        • Pfizer Investigational Site
      • Cebu, Philippines
        • Pfizer Investigational Site
      • Cebu City, Philippines, 6000
        • Pfizer Investigational Site
      • Cebu City, Philippines
        • Pfizer Investigational Site
      • Davao, Philippines
        • Pfizer Investigational Site
      • Davao City, 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, 1000
        • 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
      • Philippines, Philippines
        • Pfizer Investigational Site
      • Quezon, Philippines
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1100
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1102
        • Pfizer Investigational Site
      • Quezon City, Philippines
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1109
        • Pfizer Investigational Site
      • Rizal, Philippines
        • Pfizer Investigational Site
      • San Jose City, Philippines
        • Pfizer Investigational Site
      • Surigao City, Philippines
        • Pfizer Investigational Site
      • Tacloban, Philippines
        • Pfizer Investigational Site
      • Tacloban City, Philippines
        • Pfizer Investigational Site
      • Tagbilaran City, Philippines, 6300
        • Pfizer Investigational Site
      • Tagbilaran City, Philippines
        • Pfizer Investigational Site
      • Tagum City, Philippines
        • Pfizer Investigational Site
      • Tarlac, Philippines
        • Pfizer Investigational Site
      • Tarlac City, Philippines, 2300
        • Pfizer Investigational Site
      • Tarlac City, 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, Philippines, 1100
        • Pfizer Investigational Site
    • Agusan Del Norte
      • Butuan City, Agusan Del Norte, Philippines
        • Pfizer Investigational Site
    • Batangas
      • San Juan, Batangas, Philippines
        • Pfizer Investigational Site
    • Bohol
      • Tagbilaran City, Bohol, Philippines
        • Pfizer Investigational Site
    • Diliman
      • Quezon City, Diliman, Philippines
        • Pfizer Investigational Site
    • La Union
      • City Of San Fernando, La Union, Philippines
        • Pfizer Investigational Site
    • Manila
      • Ermita, Manila, Philippines, 1000
        • Pfizer Investigational Site
      • Tondo, Manila, Philippines, 1000
        • Pfizer Investigational Site
    • Metro Manila
      • Diliman, Quezon City, Metro Manila, Philippines, 1101
        • Pfizer Investigational Site
      • Pasig City, Metro Manila, Philippines, 1605
        • Pfizer Investigational Site
    • Pampanga
      • Angeles City, Pampanga, Philippines
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with Doxazosin mesylate GITS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Open Label
Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS
Drug: Doxazosin mesylate GITS
Doxazosin mesylate GITS 4mg to 8mg once daily
Other Names:
  • Alfadil XL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 13 (7 days after last dose)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
Change From Baseline in Systolic BP at Week 4 and Week 12
Time Frame: Baseline through Week 12
Values at Week 4 and Week 12 minus value at baseline.
Baseline through Week 12
Change From Baseline in Diastolic BP at Week 4 and Week 12
Time Frame: Baseline through Week 12
Values at Week 4 and Week 12 minus value at baseline.
Baseline through Week 12
Percentage of Participants With Postural Hypotension
Time Frame: Baseline up to Week 13 (7 days after last dose)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0351068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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