Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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).
Clinical Details
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
Study design: Time Perspective: Prospective
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: October 13, 2008
|
