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
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
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 EventNumber of Participants With the Indicated Unexpected Adverse Events
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
GSK Investigational Site, Seoul 110-749, Korea, Republic of
Additional Information
Starting date: December 2004
Last updated: May 19, 2011
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