AVODART(Dutasteride) Post-marketing Surveillance(PMS)
AVO PMS
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
1 other identifier
observational
3,977
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 17, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedResults Posted
Study results publicly available
April 18, 2011
CompletedJuly 5, 2017
June 1, 2017
5.6 years
February 17, 2011
March 24, 2011
June 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (2)
Number of Participants With a Serious Adverse Event
6 months
Number of Participants With the Indicated Unexpected Adverse Events
6 months
Study Arms (1)
Dutasteride
Patients administrated dutasteride at the site
Interventions
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.
Eligibility Criteria
The Korean BPH Patients administrated dutasteride
You may qualify if:
- The Korean BPH Patients administrated dutasteride according to the prescribing information
You may not qualify if:
- women and children and adolescents.
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Seoul, 110-749, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2011
First Posted
February 18, 2011
Study Start
December 1, 2004
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 5, 2017
Results First Posted
April 18, 2011
Record last verified: 2017-06