AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Benign Prostatic Hyperplasia Clinical Trial

— AVO PMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299571
• Other study ID #: 105194
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: May 19, 2011
• Start date: December 2004
• Est. completion date: July 2010

Study information

• Verified date: May 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Korea Food & Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3977
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Dutasteride
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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No