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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014