Last updated: 11/07/2018 07:13:33
Drug Use Investigation for AVOLVE(BPH)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for AVOLVE(BPH)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Dutasteride
Enrollment:
1000
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Yukiko Yanagita, Rie Otake, Terufumi Hara, Pascal Yoshida .Safety and Effectiveness of Dutasteride (Avolve® Capsules) in Patients with Benign Prostatic Hyperplasia (BPH): Results of Drug Use Investigation.Jap J Urol Surg.2015;28(7):1271-1280
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
December 2010 to June 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
15+ years
Accepts healthy volunteers
No
- Must be male subjects
- Use dutasteride capsules for the first time
- Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
- Subjects with severe hepatic function disorder
Inclusion and exclusion 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
Trial location(s)
No location data available.
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
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2014-20-06
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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