Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostate Hyperplasia
Phase: Phase 4
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: 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
GSK Clinical Trials call center, Thessaloniki 63 100, Greece
GSK Clinical Trials call center, Patras 265 00, Greece
GSK Clinical Trials call center, Athens 115 26, Greece
GSK Clinical Trials call center, Alexandroupoli 681 00, Greece
Additional Information
Starting date: December 2004
Last updated: January 14, 2008
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