Assessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT study

@inproceedings{Mendzelevski2012AssessmentOT,
  title={Assessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT study},
  author={Boaz Mendzelevski and Jannie Ausma and Dennis O Chanter and Patricia Robinson and Ren{\'e} Kerstens and Lieve Vandeplassche and John Camm},
  booktitle={British journal of clinical pharmacology},
  year={2012}
}
AIMS To assess steady-state effects of therapeutic and supra-therapeutic doses of prucalopride on the QT interval using a novel design involving a parallel placebo group with nested crossover for positive control. METHODS A double-blind, double-dummy, placebo- and active-controlled study was conducted in 120 healthy male and female volunteers (NCT00903747). Volunteers were randomized to receive prucalopride 2-10 mg once daily (therapeutic and supratherapeutic doses, respectively) (group 1… CONTINUE READING

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