A Phase 3 interventional study of Vernakalant Injection 20 mg/mL in Atrial Fibrillation, sponsored by Advanz Pharma. Completed at 49 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-02.
Sponsored by Advanz Pharma · Phase 3, Interventional, and Treatment
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration.
This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 356 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Advanz Pharma is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atrial fibrillation (AF) duration of 3 hours to 7 days.
Drug: Vernakalant Injection 20 mg/mL
AF duration of \>7 days to \<45 days
Drug: Vernakalant Injection 20 mg/mL
Also known as: RSD1235; Vernakalant; Vernakalant Injection; Vernakalant (iv)
To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Time frame: The proportion of patients with atrial fibrillation (AF) of 3 hours to 7 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
To assess the safety of RSD1235 in this patient population.
Time frame: The proportion of patients with AF of 3 hours to 45 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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Advanz Pharma