NCT01376284

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

June 9, 2011

Last Update Submit

July 24, 2014

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules

    1 year

Study Arms (1)

Subjects prescribed dutasteride capsules

Subjects with BPH prescribed dutasteride capsules during study period

Drug: Dutasteride

Interventions

DutasterideDRUG

Collection of safety data

Subjects prescribed dutasteride capsules

Eligibility Criteria

Age15 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese male adult subjects with benign prostatic hyperplasia (BPH) who start the treatment with dutasteride capsules

You may qualify if:

  • Must be male subjects
  • Use dutasteride capsules for the first time

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 20, 2011

Study Start

December 1, 2010

Primary Completion

October 1, 2013

Study Completion

June 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07