A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms

Trial Profile

A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Mirabegron (Primary) ; Solifenacin (Primary)
  • Indications Overactive bladder
  • Focus Therapeutic Use
  • Acronyms BESIDE
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 29 Jun 2017 According to an Astellas Pharma media release, the company has submitted a supplemental New Drug Application (sNDA) to the US FDA seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The sNDA submission is based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies.
    • 16 May 2017 Results presented at the 112th Annual Meeting of the American Urological Association.
    • 16 Apr 2017 Results assessing cardiovascular safety of the mirabegron and solifenacin combination therapy, published in the International Journal of Clinical Practice
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