Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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.
Originalsprog | Engelsk |
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Tidsskrift | Clinical Drug Investigation |
Vol/bind | 32 |
Udgave nummer | 5 |
Sider (fra-til) | 339-51 |
Antal sider | 13 |
ISSN | 1173-2563 |
DOI | |
Status | Udgivet - 1 maj 2012 |
ID: 48052459