Trial · NCT01003886
A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
NCT01003886, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH). Trials, record NCT01003886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01003886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
- NCT number
- NCT01003886
- Status
- Completed
- Enrollment
- 989 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Prostatic Hyperplasia
- Interventions
- Doxazosin mesylate GITS
- First posted
- 2009-10-29
- Last updated
- 2021-01-28
- Results first posted
- 2011-10-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | Baseline up to Week 13 (7 days after last dose) | Safety population included participants who had taken at least 1 dose of the study medication. | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | 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. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Systolic BP at Week 4 and Week 12 | Baseline through Week 12 | 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. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Diastolic BP at Week 4 and Week 12 | Baseline through Week 12 | 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. | mmHg | MEAN |
| SECONDARY | Percentage of Participants With Postural Hypotension | Baseline up to Week 13 (7 days after last dose) | Safety population included participants who had taken at least 1 dose of the study medication. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Doxazosin GITS | 14 | Participants | ||
| Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Doxazosin GITS | Baseline (n=962) | 22.30 | Standard Deviation 6.87 | Units on a scale |
| Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Doxazosin GITS | Percent change at Week 4 (n=889) | -44.90 | Standard Deviation 23.14 | Units on a scale |
| Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Doxazosin GITS | Percent change at Week 12 (n=637) | -65.10 | Standard Deviation 23.96 | Units on a scale |
| Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12 | Doxazosin GITS | Percent change at Week 12 (LOCF) (n=934) | -61.40 | Standard Deviation 24.66 | Units on a scale |
| Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Doxazosin GITS | Baseline (n=965) | 4.20 | Standard Deviation 1.04 | Units on a scale |
| Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Doxazosin GITS | Percent change at Week 4 (n=892) | -44.60 | Standard Deviation 23.62 | Units on a scale |
| Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Doxazosin GITS | Percent change at Week 12 (n=636) | -64.10 | Standard Deviation 24.08 | Units on a scale |
| Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12 | Doxazosin GITS | Percent change at Week 12 (LOCF) (n=936) | -60.50 | Standard Deviation 25.37 | Units on a scale |
| Change From Baseline in Systolic BP at Week 4 and Week 12 | Doxazosin GITS | Change at Week 4 (n=816) | -3.80 | Standard Deviation 11.07 | mmHg |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxazosin GITS | 989 | |
| Overall Study | COMPLETED | Doxazosin GITS | 759 | |
| Overall Study | NOT COMPLETED | Doxazosin GITS | 230 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Myocardial ischaemia | Cardiac disorders | Doxazosin GITS | 1 | 989 | |
| other | Vision blurred | Eye disorders | Doxazosin GITS | 1 | 989 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Doxazosin GITS | 1 | 989 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Doxazosin GITS | 1 | 989 | |
| other | Dizziness | Nervous system disorders | Doxazosin GITS | 7 | 989 | |
| other | Headache | Nervous system disorders | Doxazosin GITS | 1 | 989 | |
| other | Hypertension | Vascular disorders | Doxazosin GITS | 1 | 989 | |
| other | Hypotension | Vascular disorders | Doxazosin GITS | 2 | 989 | |
| other | Orthostatic hypotension | Vascular disorders | Doxazosin GITS | 3 | 989 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxazosin GITS | ||
| Total, other adverse events | Doxazosin GITS | 14 | 989 |
| Total, serious adverse events | Doxazosin GITS | 0 | 989 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01003886
GET https://conductscience.org/api/trials/v1/NCT01003886/registered