Trial Profile
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.
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 14 Mar 2022
Price :
$35
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At a glance
- Drugs Vernakalant (Primary)
- Indications Atrial fibrillation
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ACT-5; ACT-V
- Sponsors Correvio Pharma
- 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.
- 21 Oct 2010 Status changed from recruiting to suspended due to a single, unexpected, serious adverse event in a patient with atrial fibrillation, according to a Cardiome Pharma media release.