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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2023

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At a glance

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

    • Most Recent Events

    • 13 Sep 2021 Data (n=9167) from studies (ARIA3001,ARIA3002 and ARIB3003 and CombAT) used to develop a risk calculator to Predict Changes in International Prostate Symptom Score and Risk of Retention or Surgery in Benign Prostatic Hyperplasia Patients with Moderate-Severe Symptoms at Risk of Disease Progression Receiving Placebo, Dutasteride, Tamsulosin, or Combination Therapy presented at the 116th Annual Meeting of the American Urological Association
    • 28 Nov 2020 Results of pooled meta-analysis from six clinical studies: ARIA3001, ARIA3002, ARI40002, ARIB3003, CombAT and CONDUCT published in the British Journal of Clinical Pharmacology
    • 26 Jul 2020 Results (n=10238) of pooled analysis of 6 studies (ARIA3001, ARIA3002, ARI40002, ARIB3003, CombAT, CONDUCT) assessing impact of early vs delayed initiation of dutasteride/tamsulosin combination therapy in benign prostatic hyperplasia patients with moderate to severe lower urinary tract symptoms, presented at the 35th Congress of the European Association of Urology.
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