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AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Intervention: Dutasteride (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Participants With an Adverse Event

Secondary outcome:

Number of Participants With a Serious Adverse Event

Number of Participants With the Indicated Unexpected Adverse Events


Minimum age: N/A. Maximum age: N/A. Gender(s): Male.


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.

Locations and Contacts

GSK Investigational Site, Seoul 110-749, Korea, Republic of
Additional Information

Starting date: December 2004
Last updated: May 19, 2011

Page last updated: August 20, 2015

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