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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01299571
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : April 18, 2011
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Prostatic Hyperplasia Drug: Dutasteride

Study Type : Observational
Actual Enrollment : 3977 participants
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
Study Start Date : December 2004
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Information from the National Library of Medicine

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


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01299571     History of Changes
Other Study ID Numbers: 105194
First Posted: February 18, 2011    Key Record Dates
Results First Posted: April 18, 2011
Last Update Posted: July 5, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs