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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593593
• Other study ID #: 104244
• Secondary ID: Avodart-pv/GR
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: October 13, 2008
• Start date: December 2004

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline