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

This study has been completed.

First Received: January 3, 2008 Last Updated: October 13, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00593593

Purpose

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).

Condition
Benign Prostatic Hyperplasia

Study Type:	Observational
Study Design:	Prospective
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

Resource links provided by NLM:

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	1000
Study Start Date:	December 2004

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593593

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104244, Avodart-pv/GR
Study First Received:	January 3, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00593593 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:

benign prostate hyperplasia
Dutasteride
pharmacovigilance

Additional relevant MeSH terms:

Dutasteride
Hyperplasia
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases

Prostatic Hyperplasia
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010