Last updated: 11/03/2018 08:01:27
AVODART(dutasteride) post-marketing surveillance(PMS)AVO PMS
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with an adverse event
Timeframe: 6 months
Secondary outcomes:
Number of participants with a serious adverse event
Timeframe: 6 months
Number of participants with the indicated unexpected adverse events
Timeframe: 6 months
Interventions:
Drug: Dutasteride
Enrollment:
3977
Observational study model:
Cohort
Primary completion date:
2010-22-04
Time perspective:
Prospective
Clinical publications:
Kim JH, Choi H-M, Oh S-Y, Lee Y-S. Post-marketing surveillance of the safety of dutasteride prescribed to benign prostate hyperplasia Korean patients. J Korean Soc Clin Pharmacol Ther. 2012;20(1):85-94.
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
December 2004 to April 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- The Korean BPH Patients administrated dutasteride according to the prescribing information
- women and children and adolescents.
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Inclusion and exclusion criteria
Inclusion criteria:
- The Korean BPH Patients administrated dutasteride according to the prescribing information
Exclusion criteria:
- women and children and adolescents.
- patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-22-04
Actual study completion date
2010-22-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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