Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT00593593
- Lead Sponsor
- GlaxoSmithKline
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1000
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method