A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic Atrial Fibrillation.
Phase of Trial: Phase III
Latest Information Update: 24 Sep 2014
At a glance
- Drugs Vernakalant (Primary)
- Indications Atrial fibrillation
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ACT-5; ACT-V
- Sponsors Cardiome Pharma
- 07 Jun 2017 Biomarkers information updated
- 24 Sep 2014 New source identified and integrated (European Clinical Trials Database - EudraCT2010-018374-20).
- 21 Oct 2010 This trial is expected to be reinitiated after consultation with the trial's independent DSMB and the US FDA. The FDA have requested full data regarding the serious adverse event in South America, according to a Cardiome media release.