Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study

Research output: Contribution to journalJournal articleResearchpeer-review

Claus Graff, Johannes J. Struijk, Jørgen K. Kanters, Mads Peter Andersen, Egon Toft, Benoît Tyl

The International Conference of Harmonisation (ICH) E14 guideline for thorough QT studies requires assessing the propensity of new non-antiarrhythmic drugs to affect cardiac repolarization. The present study investigates whether a composite ECG measure of T-wave morphology (Morphology Combination Score [MCS]) can be used together with the heart rate corrected QT interval (QTc) in a fully ICH E14-compliant thorough QT study to exclude clinically relevant repolarization effects of bilastine, a novel antihistamine.
Original languageEnglish
JournalClinical Drug Investigation
Volume32
Issue number5
Pages (from-to)339-51
Number of pages13
ISSN1173-2563
DOIs
Publication statusPublished - 1 May 2012

    Research areas

  • Adult, Aza Compounds, Benzimidazoles, Cross-Over Studies, Double-Blind Method, Electrocardiography, Female, Guidelines as Topic, Histamine Antagonists, Humans, Long QT Syndrome, Male, Piperidines, Quinolines, Time Factors, Young Adult

ID: 48052459