ProstatePhase 4NCT00648323
Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
A Phase 4 study testing Doxazosin mysylate GITS in people with Prostate, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in Taiwan.
Trial summary
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate
- What is being tested?
- Doxazosin mysylate GITS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesTaiwan
- Study dates
- Nov 2003to Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination [DRE] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
Who cannot join
- Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
- Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Pfizer Investigational Site
Kaohsiung City, 813
Pfizer Investigational Site
Taichung
Pfizer Investigational Site
Taipei
Pfizer Investigational Site
Taoyuan
About this study
Official title: A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
- Conditions
- Prostate
- Being tested
- Doxazosin mysylate GITS
- Keywords
- Benign Prostate Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin mysylate GITSDrug
Subjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Doxazosin mysylate GITS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the maximum urinary flow rate (Qmax) from baseline
Measured: 8 weeks
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Measured: 8 weeks
Secondary outcomes (3)
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Measured: 4 weeks
Change in the maximum urinary flow rate (Qmax) from baseline
Measured: 4 weeks
Change in the quality of life (QoL) assessment index score from baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648323
- Sponsor's protocol ID
- A0351063
- Status last verified
- Jan 2021
- First submitted
- 27 Mar 2008
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
- ClinicalTrials.gov ID
- NCT00648323
- Acronym / sponsor ID
- A0351063
- Conditions
- Prostate
- Keywords
- Benign Prostate Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Doxazosin mysylate GITS |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination [DRE] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
Key exclusion criteria (2 listed)
- Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
- Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxazosin mysylate GITSSubjects initiated on 4 mg doxazosin GITS once daily at Visit 1 for four weeks. At Visit 2 (Week 4) increased to 8 mg Doxazosin GITS if efficacy response criteria not met. | Drug | A |
Primary outcome
Change in the maximum urinary flow rate (Qmax) from baseline
Time frame: 8 weeks
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time frame: 8 weeks
3 secondary outcomes
Change in the International Prostate Symptom Score (IPSS) total score from baseline
Time frame: 4 weeks
Change in the maximum urinary flow rate (Qmax) from baseline
Time frame: 4 weeks
Change in the quality of life (QoL) assessment index score from baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxazosin mysylate GITS in people with Prostate, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the maximum urinary flow rate (Qmax) from baseline (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.