Benign Prostatic HyperplasiaAVO PMSNCT01299571
AVODART(Dutasteride) Post-marketing Surveillance(PMS)
An observational study of Benign Prostatic Hyperplasia and Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- How many people
- 3,977 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2004to Jul 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Korean BPH Patients administrated dutasteride
Who may be able to join
- The Korean BPH Patients administrated dutasteride according to the prescribing information
Who cannot join
- women and children and adolescents.
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVODART(Dutasteride) Administered in Korean BPH(Benign Prostatic Hyperplasia) Patients According to the Prescribing Information
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
- Being tested
- Dutasteride
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Patients administrated dutasteride at the site Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
Measured: 6 months
Secondary outcomes (2)
Number of Participants With a Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Measured: 6 months
Number of Participants With the Indicated Unexpected Adverse Events
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startDec 2004
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299571
- Sponsor's protocol ID
- 105194
- Acronym
- AVO PMS
- Status last verified
- Jun 2017
- First submitted
- 17 Feb 2011
- Last updated
- 5 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVODART(Dutasteride) Administered in Korean BPH(Benign Prostatic Hyperplasia) Patients According to the Prescribing Information
- ClinicalTrials.gov ID
- NCT01299571
- Acronym / sponsor ID
- AVO PMS / 105194
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,977 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 18 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | – | Drug: DutasteridePatients administrated dutasteride at the site |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Korean BPH Patients administrated dutasteride
Key inclusion criteria (1 listed)
- The Korean BPH Patients administrated dutasteride according to the prescribing information
Key exclusion criteria (2 listed)
- women and children and adolescents.
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
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 |
|---|---|---|
| DutasterideBasically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively. | Drug | Dutasteride |
Primary outcome
Number of Participants With an Adverse Event
Time frame: 6 months
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
2 secondary outcomes
Number of Participants With a Serious Adverse Event
Time frame: 6 months
Number of Participants With the Indicated Unexpected Adverse Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in South Korea.
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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With an Adverse Event (time frame: 6 months). 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 5 Jul 2017.