We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593593
First Posted: January 15, 2008
Last Update Posted: October 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
January 3, 2008
January 15, 2008
October 15, 2008
December 2004
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00593593 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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).
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Benign Prostatic Hyperplasia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Not Provided
Not Provided

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
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Greece
 
NCT00593593
104244
Avodart-pv/GR
Not Provided
Not Provided
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008