Designing clinical trials for paroxysmal atrial tachycardia and other paroxysmal arrhythmias

  • Edward L.C. Pritchett
    Correspondence
    Correspondence should be addressed to: Edward L. C. Pritchett, M.D., Box 3477, Duke University Medical Center, Durham, NA 27710, U.S.A. [Tel: (919) 684-6516].
    Affiliations
    Division of Cardiology. Department of Medicine and the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina, U.S.A.
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  • Kerry L. Lee
    Affiliations
    Division of Cardiology. Department of Medicine and the Division of Biometry, Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina, U.S.A.
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      Abstract

      Paroxysmal atrial tachycardia may be useful as a model for designing clinical trials of paroxysmal tachycardia. Individual occurrences of paroxysmal atrial tachycardia are clinically independent events. and the time periods between events follow an exponential probability distribution: i.e. paroxysmal atrial tachycardia behaves like a Poisson process. We propose that treatment of paroxysmal atrial tachycardia can be studied efficiently using a clinical trial with a two period cross-over design in which placebo and investigational therapy are delivered in random order. A screening phase, dose ranging phase, and both limbs of a cross-over plane can be completed in 180 days or less in each patient.

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