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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.
This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxazosin mesylate GITS | Drug | Doxazosin mesylate GITS 4mg to 8mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Filipino adult males diagnosed with Benign Prostatic Hyperplasia (BPH) and prescribed with Doxazosin mesylate GITS
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Butuan | Agusan Del Norte | Philippines | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxazosin GITS | Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| 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 |
| 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 |
| 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) |
| San Juan City |
| Batangas |
| Philippines |
| Pfizer Investigational Site | Tagbilaran City | Bohol | Philippines |
| Pfizer Investigational Site | Quezon City | Diliman | Philippines |
| Pfizer Investigational Site | City of San Fernando | La Union | Philippines |
| Pfizer Investigational Site | Ermita | Manila | 1000 | Philippines |
| Pfizer Investigational Site | Tondo | Manila | 1000 | Philippines |
| Pfizer Investigational Site | Diliman, Quezon City | National Capital Region | 1101 | Philippines |
| Pfizer Investigational Site | Pasig | National Capital Region | 1605 | Philippines |
| Pfizer Investigational Site | Angeles City | Pampanga | Philippines |
| Pfizer Investigational Site | 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 | Philippines |
| Pfizer Investigational Site | Cagayan de Oro | Philippines |
| Pfizer Investigational Site | Cebu | Philippines |
| Pfizer Investigational Site | Cebu City | 6000 | Philippines |
| Pfizer Investigational Site | Cebu City | Philippines |
| Pfizer Investigational Site | City of Muntinlupa | Philippines |
| Pfizer Investigational Site | Davao City | Philippines |
| Pfizer Investigational Site | Gallares City | Philippines |
| Pfizer Investigational Site | General Santos | 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 | Philippines |
| Pfizer Investigational Site | Lingayen, Pangasinan | Philippines |
| Pfizer Investigational Site | Makati City | Philippines |
| Pfizer Investigational Site | Malabon | Philippines |
| Pfizer Investigational Site | Manadaluyong | Philippines |
| Pfizer Investigational Site | Mandaluyong | Philippines |
| Pfizer Investigational Site | Mandaue City | Philippines |
| Pfizer Investigational Site | Manila | 1000 | Philippines |
| Pfizer Investigational Site | Manila | Philippines |
| Pfizer Investigational Site | Marikina City | Philippines |
| Pfizer Investigational Site | Mindanaw | Philippines |
| Pfizer Investigational Site | Nueva Ecija | Philippines |
| Pfizer Investigational Site | Nueva Vizcaya | Philippines |
| Pfizer Investigational Site | Ozamiz | Philippines |
| Pfizer Investigational Site | Pampanga | Philippines |
| Pfizer Investigational Site | Pasig | Philippines |
| Pfizer Investigational Site | Philippines | Philippines |
| Pfizer Investigational Site | Quezon | Philippines |
| Pfizer Investigational Site | Quezon City | 1100 | Philippines |
| Pfizer Investigational Site | Quezon City | 1102 | Philippines |
| Pfizer Investigational Site | Quezon City | 1109 | Philippines |
| Pfizer Investigational Site | Quezon City | Philippines |
| Pfizer Investigational Site | Rizal | Philippines |
| Pfizer Investigational Site | San Jose | Philippines |
| Pfizer Investigational Site | Surigao City | Philippines |
| Pfizer Investigational Site | Tacloban City | Philippines |
| Pfizer Investigational Site | Tagbilaran City | 6300 | Philippines |
| Pfizer Investigational Site | Tagbilaran City | Philippines |
| Pfizer Investigational Site | Tagum | Philippines |
| Pfizer Investigational Site | Tarlac City | 2300 | Philippines |
| Pfizer Investigational Site | Tarlac City | Philippines |
| Pfizer Investigational Site | Tuguegarao City | Philippines |
| Pfizer Investigational Site | Valenzuela | Philippines |
| Pfizer Investigational Site | Vigan | Philippines |
| Pfizer Investigational Site | Visayas | Philippines |
| Pfizer Investigational Site | West Fairview, Quezon City | 1100 | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxazosin GITS | Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Systolic blood pressure (BP) | N=900 for the parameter analyzed. | Mean | Standard Deviation | Millimeters of mercury (mmHg) |
| ||||||||||||||||
| Diastolic BP | N=900 for the parameter analyzed. | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety population included participants who had taken at least 1 dose of the study medication. | Posted | Number | Participants | Baseline up to Week 13 (7 days after last dose) |
|
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| ||||||||||||||||||||||||||
| 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. | Full analysis set (FAS) population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the last observation carried forward (LOCF). The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively. | Posted | Mean | Standard Deviation | Units on a scale | 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. | FAS population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the LOCF. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively. | Posted | Mean | Standard Deviation | Units on a scale | 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. | Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively. | Posted | Mean | Standard Deviation | mmHg | 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. | Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline through Week 12 |
|
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| 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. | Safety population included participants who had taken at least 1 dose of the study medication. | Posted | Number | Percentage of participants | Baseline up to Week 13 (7 days after last dose) |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxazosin GITS | Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks. | 0 | 989 | 14 | 989 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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