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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX as Applicable in Patients with Idiopathic Overactive Bladder with Urinary Incontinence.

Trial Profile

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX as Applicable in Patients with Idiopathic Overactive Bladder with Urinary Incontinence.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Overactive bladder; Urinary incontinence
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBARK
  • Sponsors Allergan
  • Most Recent Events

    • 01 Nov 2023 Results of pooled post hoc analysis (n=1504 from studies NCT00910845, NCT00910520, NCT01767519, NCT01945489) assessing the effects of age, gender, and postvoid residual volume on catheterization rates after treatment with OnabotulinumtoxinA for Overactive Bladder published in the European Urology Open Science
    • 17 Oct 2021 Results of a pooled gender-focused analysis assessing long-term safety effects of onabotulinumtoxin A from following clinical studies: NCT00910845, NCT00910520, NCT01767519, NCT01945489 and NCT00915525 presented at the 51st Annual Meeting of the International Continence Society
    • 17 Oct 2021 Results (n=1564) of pooled analysis from two pivotal trials (NCT00910845 and NCT00910520) and two post-marketing studies (NCT01767519 and NCT01945489) assessing the efficacy and safety of onabotulinumtoxin A in a sufficient number of male patients with OAB and UI, presented at the 51st Annual Meeting of the International Continence Society.
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