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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: 03 Nov 2018

At a glance

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

    • 07 May 2018 According to an Astellas Pharma media release, the U.S. Food and Drug Administration (FDA) FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with solifenacin succinate for the Treatment of Overactive Bladder Symptoms.
    • 12 Apr 2018 Results of cardiovascular safety of mirabegron and solifenacin (n=3398) published in the Journal of Clinical Pharmacology.
    • 12 Sep 2017 According to an Astellas Pharma media release, the U.S. Food and Drug Administration (FDA) has accepted for review of a supplemental New Drug Application (sNDA) that seeks 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 anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 28, 2018.
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