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A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

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Trial Profile

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Mirabegron (Primary) ; Tamsulosin
  • Indications Overactive bladder
  • Focus Therapeutic Use
  • Acronyms PLUS
  • Sponsors Astellas Pharma; Astellas Pharma Global Development

    • Most Recent Events

    • 02 Jan 2020 Results published in the Journal of Urology
    • 05 May 2019 Primary endpoint has been met. (Change from Baseline to Week 12 (End of Treatment) in mean number of micturitions per day based on a 3-day diary), according to an Astellas Pharma media release.
    • 05 May 2019 According to an Astellas Pharma media release, results from the study were were presented during a plenary session at the American Urological Association (AUA) 2019 Annual Meeting.

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