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

NCT ID: NCT00593593

Last Updated: 2008-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31

Brief Summary

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).

Conditions

Benign Prostatic Hyperplasia

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

Avodart-pv/GR

Identifier Type: -

Identifier Source: secondary_id

104244

Identifier Type: -

Identifier Source: org_study_id