AVODART(Dutasteride) Post-marketing Surveillance(PMS)

GlaxoSmithKline3,977 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

3,977

Conditions

Benign Prostatic Hyperplasia Prostatic Hyperplasia

Interventions

DutasterideDRUG

Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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 (1)

GSK Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants With an Adverse Event

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.

Time frame: 6 months

Secondary Outcomes

Number of Participants With a Serious Adverse Event

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.

Time frame: 6 months

Number of Participants With the Indicated Unexpected Adverse Events

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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