AVODART(Dutasteride) Post-marketing Surveillance(PMS) (AVO PMS)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01299571
First received: February 17, 2011
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention
Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Drug: Dutasteride

Study Type: Observational
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.


Enrollment: 3977
Study Start Date: December 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dutasteride
Patients administrated dutasteride at the site
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The Korean BPH Patients administrated dutasteride

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299571

Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 110-749
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01299571     History of Changes
Other Study ID Numbers: 105194
Study First Received: February 17, 2011
Results First Received: March 24, 2011
Last Updated: May 19, 2011
Health Authority: Korea: Korea Food & Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014