This protocol is a randomized, double-blind, placebo-controlled, multi-center, parallel design clinical trial of the safety and efficacy of azimilide in patients with history of symptomatic atrial fibrillation, atrial flutter or paroxysmal supraventricular tachycardia. Patients must, in the judgment of their physician, require treatment. Patients will be stratified according to one of two index arrhythmias. One stratum will include patients with atrial fibrillation or flutter; the other will include patients with paroxysmal supraventricular tachycardia. Study subjects will be randomly assigned to receive daily oral doses of 100 mg of azimilide or placebo. Patients will be assigned to treatment in a ratio of two patients in the active treatment group to one patient in the placebo group. At least 234 patients with an index arrhythmia of atrial fibrillation or flutter will be enrolled in the trial. Although not a requirement for trial completion, the goal is to recruit 54 patients with an index arrhythmia of paroxysmal supraventricular tachycardia. The trial will consist of a three-day loading period followed by an efficacy period of 270 days (approximately 9 months). Patients will take their trial medication twice daily for the first three days and once daily thereafter.

Project Start
Project End
Budget Start
Budget End
Support Year
35
Fiscal Year
1996
Total Cost
Indirect Cost
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Ahmed, Zuhayer; Prasad, Indrajit; Rahman, Hafizur et al. (2016) A Male with Extreme Subcutaneous Insulin Resistance: A Case Report. Rom J Diabetes Nutr Metab Dis 23:209-213
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Barroso, Julie; Leserman, Jane; Harmon, James L et al. (2015) Fatigue in HIV-Infected People: A Three-Year Observational Study. J Pain Symptom Manage 50:69-79
Stafford-Smith, Mark; Li, Yi-Ju; Mathew, Joseph P et al. (2015) Genome-wide association study of acute kidney injury after coronary bypass graft surgery identifies susceptibility loci. Kidney Int 88:823-32

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