Last updated: 11/03/2018 00:31:48
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1000
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
October 2004 to December 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
- Subject should be diagnosed with benign prostate hyperplasia
- 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
Inclusion and exclusion 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-18-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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