Drug Use Investigation for AVOLVE(BPH)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Intervention: Dutasteride (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The study is designed to investigate the safety and efficacy of dutasteride capsules 0. 5 mg
collected from the required number of Japanese subjects with benign prostatic hyperplasia
(BPH) in order to identify concerns or problems, if any, about the efficacy and safety of
its use at post-marketing clinical settings.
Clinical Details
Official title: Drug Use Investigation for AVOLVE(BPH)
Study design: Time Perspective: Prospective
Primary outcome: The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Must be male subjects
- Use dutasteride capsules for the first time
Exclusion Criteria:
- Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
- Subjects with severe hepatic function disorder
- Dutasteride capsules shall not be used to female or child
Locations and Contacts
Additional Information
Starting date: December 2010
Last updated: July 24, 2014
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