AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Completed

• Conditions: Benign Prostatic Hyperplasia; Prostatic Hyperplasia
• Interventions: Drug: Dutasteride

• Registration Number: NCT01299571
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Results First Submitted: 2011-03-24
• Results First Submitted QC: 2011-03-24
• Results First Posted: 2011-04-18
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3977

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dutasteride	Dutasteride	Patients administrated dutasteride at the site

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Adverse Event	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Indicated Unexpected Adverse Events	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. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Number of Participants With a Serious Adverse Event	6 months	A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of