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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

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.
OriginalsprogEngelsk
TidsskriftClinical Drug Investigation
Vol/bind32
Udgave nummer5
Sider (fra-til)339-51
Antal sider13
ISSN1173-2563
DOI
StatusUdgivet - 1 maj 2012

ID: 48052459