Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study
Research output: Contribution to journal › Journal article › Research › peer-review
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 language | English |
|---|---|
| Journal | Clinical Drug Investigation |
| Volume | 32 |
| Issue number | 5 |
| Pages (from-to) | 339-51 |
| Number of pages | 13 |
| ISSN | 1173-2563 |
| DOIs | |
| Publication status | Published - 1 May 2012 |
- 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
Research areas
ID: 48052459