Drug Use Investigation for AVOLVE(BPH)

July 24, 2014 updated by: GlaxoSmithKline
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects prescribed dutasteride capsules
Subjects with BPH prescribed dutasteride capsules during study period
Drug: Dutasteride
Collection of safety data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Hyperplasia

Clinical Trials on Dutasteride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe