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

GlaxoSmithKline1 site in 1 country3,977 target enrollmentDecember 2004

ConditionsBenign Prostatic Hyperplasia Prostatic Hyperplasia

InterventionsDutasteride

DrugsDutasteride

Overview

Phase: Not Applicable
Intervention: Dutasteride
Conditions: Benign Prostatic Hyperplasia
Sponsor: GlaxoSmithKline
Enrollment: 3977
Locations: 1
Primary Endpoint: Number of Participants With an Adverse Event
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

July 2010

Last Updated

8 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.

Arms & Interventions

Dutasteride

Patients administrated dutasteride at the site

Intervention: Dutasteride

Outcomes

Primary Outcomes

Number of Participants With an Adverse Event

Time Frame: 6 months

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.