Qt effects of duloxetine at supratherapeutic doses a placebo and positive controlled study

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Abstract. Background/Aims. The electrophysiological effects of duloxetine at supratherapeutic exposures were evaluated to ensure compliance with regulatory criteria and to definitively establish the absence of QT/QTc prolongation. Zhang, J. and Machado, S.G., , Statistical issues including design and sample size calculation in thorough QT/QTc studies, Journal of Biopharmaceutical Statistics, l8(3)l~ Zhang, L., Chappell, J., Gonzales, C.R., et al., , QT effects of duloxetine at supratherapeutic doses: A placebo and positive controlled.

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We compared the safety of duloxetine in patients with (CV-positive) and without (CV-negative) historical/comorbid cardiovascular conditions at study entry. . Data were pooled from three randomized, double-blind, placebo (PBO)-controlled, parallel, fixed-dose multicenter clinical trials of duloxetine in patients with DPNP. Moxifloxacin, which produces modest degrees of QT prolongation, is commonly used as a positive control in TQT studies. The number of subjects in the original study was relatively large because these subjects were subsequently randomized to receive multiple doses of either placebo or the investigational drug in a.

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