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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

January 3, 2008
October 13, 2008
December 2004
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Complete list of historical versions of study NCT00593593 on ClinicalTrials.gov Archive Site
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Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia

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).

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Observational
Time Perspective: Prospective
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Benign Prostatic Hyperplasia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
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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
Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00593593
104244, Avodart-pv/GR
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Study Director, GSK
GlaxoSmithKline
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP