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: 21 Aug 2017
At a glance
- Drugs Vernakalant (Primary)
- Indications Atrial fibrillation
- Focus Adverse reactions
- Acronyms SPECTRUM
- Sponsors Cardiome Pharma
- 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.