A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

Trial Profile

A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2016

At a glance

  • Drugs Dutasteride (Primary) ; Tamsulosin (Primary)
  • Indications Benign prostatic hyperplasia; Lower urinary tract symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms CombAT
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 18 Feb 2011 Four-year results according to baseline characteristics published in the BJU International.
    • 25 Jun 2010 Four-year results according to baseline prostate volume were presented at the 105th Annual Meeting of the American Urological Association.
    • 14 Jun 2010 The US FDA has approved dutasteride and tamsulosin fixed-dose combination [Jalyn] for symptomatic BPH in men with an enlarged prostate, based on the 2-year results from this trial, as reported in a media release from GlaxoSmithKline.
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