Prostatic Hyperplasia
Conditions
Keywords
post marketing surveillance Filipino benign prostatic hyperplasia BPH Doxazosin 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.
Interventions
DRUGDoxazosin mesylate GITS
Doxazosin mesylate GITS 4mg to 8mg once daily
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | 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. |
| Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | 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. |
| Change From Baseline in Systolic BP at Week 4 and Week 12 | Baseline through Week 12 | Values at Week 4 and Week 12 minus value at baseline. |
| Change From Baseline in Diastolic BP at Week 4 and Week 12 | Baseline through Week 12 | Values at Week 4 and Week 12 minus value at baseline. |
| Percentage of Participants With Postural Hypotension | 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. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 989 |
| Total | 989 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 169 |
| Overall Study | Other | 14 |
| Overall Study | Withdrawal by Subject | 39 |
Baseline characteristics
| Characteristic | Doxazosin GITS |
|---|---|
| Age, Continuous | 62.50 Years STANDARD_DEVIATION 10.1 |
| Diastolic BP | 80.50 mmHg STANDARD_DEVIATION 9.35 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 989 Participants |
| Systolic blood pressure (BP) | 127.80 Millimeters of mercury (mmHg) STANDARD_DEVIATION 15.18 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 989 |
| serious Total, serious adverse events | 0 / 989 |
Outcome results
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.
Time frame: Baseline up to Week 13 (7 days after last dose)
Population: Safety population included participants who had taken at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxazosin GITS | Number of Participants With Adverse Events (AEs) | 14 Participants |
Secondary
Change From Baseline in Diastolic BP at Week 4 and Week 12
Values at Week 4 and Week 12 minus value at baseline.
Time frame: Baseline through Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxazosin GITS | Change From Baseline in Diastolic BP at Week 4 and Week 12 | Change at Week 4 (n=816) | -1.50 mmHg | Standard Deviation 7.95 |
| Doxazosin GITS | Change From Baseline in Diastolic BP at Week 4 and Week 12 | Change at Week 12 (n=583) | -2.40 mmHg | Standard Deviation 8.49 |
Secondary
Change From Baseline in Systolic BP at Week 4 and Week 12
Values at Week 4 and Week 12 minus value at baseline.
Time frame: Baseline through Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxazosin GITS | Change From Baseline in Systolic BP at Week 4 and Week 12 | Change at Week 4 (n=816) | -3.80 mmHg | Standard Deviation 11.07 |
| Doxazosin GITS | Change From Baseline in Systolic BP at Week 4 and Week 12 | Change at Week 12 (n=583) | -5.70 mmHg | Standard Deviation 11.22 |
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.
Time frame: Baseline up to Week 13 (7 days after last dose)
Population: Safety population included participants who had taken at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxazosin GITS | Percentage of Participants With Postural Hypotension | 0.3 Percentage of participants |
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxazosin GITS | Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Baseline (n=962) | 22.30 Units on a scale | Standard Deviation 6.87 |
| Doxazosin GITS | Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Percent change at Week 4 (n=889) | -44.90 Units on a scale | Standard Deviation 23.14 |
| Doxazosin GITS | Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Percent change at Week 12 (n=637) | -65.10 Units on a scale | Standard Deviation 23.96 |
| Doxazosin GITS | Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Percent change at Week 12 (LOCF) (n=934) | -61.40 Units on a scale | Standard Deviation 24.66 |
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.
Time frame: Baseline, Week 4 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxazosin GITS | Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Baseline (n=965) | 4.20 Units on a scale | Standard Deviation 1.04 |
| Doxazosin GITS | Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Percent change at Week 4 (n=892) | -44.60 Units on a scale | Standard Deviation 23.62 |
| Doxazosin GITS | Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Percent change at Week 12 (n=636) | -64.10 Units on a scale | Standard Deviation 24.08 |
| Doxazosin GITS | Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Percent change at Week 12 (LOCF) (n=936) | -60.50 Units on a scale | Standard Deviation 25.37 |