AVODART(Dutasteride) Post-marketing Surveillance(PMS) (AVO PMS)
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|ClinicalTrials.gov Identifier: NCT01299571|
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : April 18, 2011
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment|
|Benign Prostatic Hyperplasia Prostatic Hyperplasia||Drug: Dutasteride|
|Study Type :||Observational|
|Actual Enrollment :||3977 participants|
|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|
|Study Start Date :||December 2004|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
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.
- 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.
- Number of Participants With a Serious Adverse Event [ Time Frame: 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.
- Number of Participants With the Indicated Unexpected Adverse Events [ 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. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299571
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 110-749|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|