A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate

Trial Profile

A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Vernakalant (Primary)
  • Indications Atrial fibrillation
  • Focus Adverse reactions
  • Acronyms SPECTRUM
  • Sponsors Cardiome Pharma
  • Most Recent Events

    • 21 Aug 2017 According to a Cardiome Pharma media release, the company proposed resubmission of the NDA augmented by interim results from over 1,100 patients enrolled in this SPECTRUM study.
    • 29 Jul 2016 Planned End Date changed from 1 Aug 2016 to 1 Dec 2017.
    • 29 Jul 2016 Planned primary completion date changed from 1 Aug 2016 to 1 Dec 2017.
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