AVODART(Dutasteride) Post-marketing Surveillance(PMS)

NCT ID: NCT01299571

Last Updated: 2017-07-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3977 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2010-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dutasteride

Patients administrated dutasteride at the site

Dutasteride

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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105194

Identifier Type: -

Identifier Source: org_study_id

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