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Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00593593
First received: January 3, 2008
Last updated: October 13, 2008
Last verified: October 2008
History of Changes
  Purpose

This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).


Condition
Benign Prostatic Hyperplasia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 1000
Study Start Date: December 2004
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
  • Subject should be diagnosed with benign prostate hyperplasia
  • Subject's prostate volume should be equal or greater than 30 cm3

Exclusion Criteria:

  • Known hypersensitivity to any of the AVODART compounds
  • Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial
  • Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5.
  • History of severe liver failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593593

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00593593     History of Changes
Other Study ID Numbers: 104244, Avodart-pv/GR
Study First Received: January 3, 2008
Last Updated: October 13, 2008
Health Authority: Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:
benign prostate hyperplasia
Dutasteride
pharmacovigilance

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 23, 2013