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Trial record 86 of 117 for:    DUTASTERIDE

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

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. Identifier: NCT00593593
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : October 15, 2008
Information provided by:

Brief Summary:
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 or disease
Benign Prostatic Hyperplasia

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Study Type : Observational
Enrollment : 1000 participants
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
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00593593

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

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Responsible Party: Study Director, GSK Identifier: NCT00593593     History of Changes
Other Study ID Numbers: 104244
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008
Keywords provided by GlaxoSmithKline:
benign prostate hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs