A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
Phase of Trial: Phase IV
Latest Information Update: 29 Jan 2018
At a glance
- Drugs Vernakalant (Primary)
- Indications Atrial fibrillation
- Focus Adverse reactions
- Acronyms SPECTRUM
- Sponsors Cardiome Pharma
- 23 Jan 2018 Planned End Date changed from 1 Dec 2017 to 1 Aug 2018.
- 23 Jan 2018 Planned primary completion date changed from 1 Dec 2017 to 1 Apr 2018.
- 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.