Trial Outcomes & Findings for A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH) (NCT NCT01003886)
NCT ID: NCT01003886
Last Updated: 2021-01-28
Results Overview
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
COMPLETED
989 participants
Baseline up to Week 13 (7 days after last dose)
2021-01-28
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
989
|
|
Overall Study
COMPLETED
|
759
|
|
Overall Study
NOT COMPLETED
|
230
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Lost to Follow-up
|
169
|
|
Overall Study
Withdrawal by Subject
|
39
|
|
Overall Study
Other
|
14
|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)
Baseline characteristics by cohort
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
Age, Continuous
|
62.50 Years
STANDARD_DEVIATION 10.10 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
989 Participants
n=39 Participants
|
|
Systolic blood pressure (BP)
|
127.80 Millimeters of mercury (mmHg)
STANDARD_DEVIATION 15.18 • n=39 Participants
|
|
Diastolic BP
|
80.50 mmHg
STANDARD_DEVIATION 9.35 • n=39 Participants
|
PRIMARY outcome
Timeframe: 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.
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
Outcome measures
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: 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.
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.
Outcome measures
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 4 and Week 12Population: 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.
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.
Outcome measures
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: 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.
Values at Week 4 and Week 12 minus value at baseline.
Outcome measures
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline through Week 12Population: 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.
Values at Week 4 and Week 12 minus value at baseline.
Outcome measures
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Doxazosin GITS
n=989 Participants
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.
|
|---|---|
|
Percentage of Participants With Postural Hypotension
|
0.3 Percentage of participants
|
Adverse Events
Doxazosin GITS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxazosin GITS
n=989 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
1/989
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.
|
|
Eye disorders
Vision blurred
|
0.10%
1/989
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/989
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.10%
1/989
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.
|
|
Nervous system disorders
Dizziness
|
0.71%
7/989
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.
|
|
Nervous system disorders
Headache
|
0.10%
1/989
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.
|
|
Vascular disorders
Hypertension
|
0.10%
1/989
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.
|
|
Vascular disorders
Hypotension
|
0.20%
2/989
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.
|
|
Vascular disorders
Orthostatic hypotension
|
0.30%
3/989
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER