A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Trial Profile

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Mirabegron (Primary) ; Solifenacin (Primary)
  • Indications Overactive bladder
  • Focus Registrational; Therapeutic Use
  • Acronyms SYNERGY I
  • 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.
    • 18 Apr 2017 Primary endpoint (Change from baseline in mean number of incontinence episodes per 24 hours at End of Treatment (EoT)) has not been met, according to the results published in the BJU International
    • 18 Apr 2017 Results published in the BJU International
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