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NCT01376284 Clinical Trial

Drug Use Investigation for AVOLVE(BPH)

Prostatic Hyperplasia Clinical Trial

Official title:
Drug Use Investigation for AVOLVE(BPH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01376284
Other study ID # 114125
Secondary ID
Status Completed
Phase N/A
First received June 9, 2011
Last updated July 24, 2014
Start date December 2010
Est. completion date June 2014

Study information
Verified date July 2014
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date June 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Male
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Must be male subjects

- Use dutasteride capsules for the first time

Exclusion Criteria:

- Subjects who is hypersensitivity to dutasteride or 5a reductase inhibitor

- Subjects with severe hepatic function disorder

- Dutasteride capsules shall not be used to female or child

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Dutasteride
Collection of safety data

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules 1 year No
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