Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Brief Summary

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This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Keywords

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benign prostate hyperplasia Dutasteride pharmacovigilance

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
* Subject should be diagnosed with benign prostate hyperplasia
* Subject's prostate volume should be equal or greater than 30 cm3

Exclusion Criteria

* Known hypersensitivity to any of the AVODART compounds
* Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial
* Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5.
* History of severe liver failure

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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Greece

Other Identifiers

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Avodart-pv/GR

Identifier Type: -

Identifier Source: secondary_id

104244