AVODART(Dutasteride) Post-marketing Surveillance(PMS) (AVO PMS)
This study has been completed.
Information provided by:
First received: February 17, 2011
Last updated: May 19, 2011
Last verified: May 2011
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of Participants With an Adverse Event [ Time Frame: 6 months ] [ Designated as safety issue: No ]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:
- Number of Participants With a Serious Adverse Event [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Number of Participants With the Indicated Unexpected Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2004|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Patients administrated dutasteride at the site
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.
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