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

Completed
Phase of Trial: Phase IV

Latest Information Update: 11 Jun 2018

At a glance

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

    • 11 Jun 2018 According to the Correvio Pharma media release, FDA informed company that it would be permissible to resubmit the BRINAVESS New Drug Application (NDA) and company expects to schedule a Pre-NDA meeting with the Division of Cardiovascular and Renal Products to discuss the content and format of a potential resubmission of the NDA in the fourth quarter of 2018.
    • 09 May 2018 Status changed to completed.
    • 17 Apr 2018 According to a Cardiome Pharma media release, full clinical study report (CSR) will be available during third quarter 2018 and Cardiome plans to publish these data.
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