N/A
N=3,977
AVODART(Dutasteride) Post-marketing Surveillance(PMS)
Benign Prostatic Hyperplasia · Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT01299571 ↗Enrolled (actual)
3,977
Serious AEs
0.1%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With an Adverse Event — 146 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dutasteride (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event |
146 | — |
| SECONDARY Number of Participants With a Serious Adverse Event |
5 | — |
| SECONDARY Number of Participants With the Indicated Unexpected Adverse Events |
2; 3; 2; 2; 2; 1 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01299571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.