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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 27 Dec 2022

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At a glance

  • Drugs Vernakalant (Primary)
  • Indications Atrial fibrillation
  • Focus Adverse reactions; Registrational
  • Acronyms SPECTRUM
  • Sponsors Cardiome Pharma; Merck Sharp & Dohme

    • Most Recent Events

    • 24 Dec 2019 According to a Correvio media release, company intends to request a meeting with the FDA as soon as possible to discuss the design and specifics of a potential study to address the FDA's concerns and currently believes that enrollment of both US and ex-US subjects may be acceptable to the Agency based on preliminary feedback.
    • 24 Dec 2019 According to a Correvio media release, In the CRL, the FDA stated the data do not provide reassuring evidence of safety. Company will need to develop an approach to select patients who are at low risk of adverse cardiovascular reactions and that data from an additional, potentially uncontrolled, clinical study will be needed to assess cardiovascular risk in the and to support an NDA resubmission.
    • 24 Dec 2019 According to a Correvio media release, company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Brinavess™ (vernakalant IV), for the conversion of atrial fibrillation (AF). The CRL stated that the FDA determined it cannot approve the Brinavess NDA in its present form and provided recommendations needed for resubmission.
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