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Drug Use Investigation for AVOLVE (Dutasteride) (Benign Prostatic Hyperplasia)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376284
First received: June 9, 2011
Last updated: January 21, 2013
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Prostatic Hyperplasia
 Drug: Dutasteride

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for AVOLVE (Dutasteride) (Benign Prostatic Hyperplasia)

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: December 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed dutasteride capsules
Subjects with BPH prescribed dutasteride capsules during study period
 Drug: Dutasteride
Collection of safety data

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376284

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376284     History of Changes
Other Study ID Numbers: 114125
Study First Received: June 9, 2011
Last Updated: January 21, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013