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

• 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: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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 Design

• 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
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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.

Contacts and Locations

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

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

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; 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