Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study
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Effects of bilastine on T-wave morphology and the QTc interval : a randomized, double-blind, placebo-controlled, thorough QTc study. / Graff, Claus; Struijk, Johannes J.; Kanters, Jørgen K.; Andersen, Mads Peter; Toft, Egon; Tyl, Benoît.
In: Clinical Drug Investigation, Vol. 32, No. 5, 01.05.2012, p. 339-51.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effects of bilastine on T-wave morphology and the QTc interval
T2 - a randomized, double-blind, placebo-controlled, thorough QTc study
AU - Graff, Claus
AU - Struijk, Johannes J.
AU - Kanters, Jørgen K.
AU - Andersen, Mads Peter
AU - Toft, Egon
AU - Tyl, Benoît
PY - 2012/5/1
Y1 - 2012/5/1
N2 - 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.
AB - 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.
KW - Adult
KW - Aza Compounds
KW - Benzimidazoles
KW - Cross-Over Studies
KW - Double-Blind Method
KW - Electrocardiography
KW - Female
KW - Guidelines as Topic
KW - Histamine Antagonists
KW - Humans
KW - Long QT Syndrome
KW - Male
KW - Piperidines
KW - Quinolines
KW - Time Factors
KW - Young Adult
U2 - 10.2165/11599270-000000000-00000
DO - 10.2165/11599270-000000000-00000
M3 - Journal article
C2 - 22393898
VL - 32
SP - 339
EP - 351
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
SN - 1173-2563
IS - 5
ER -
ID: 48052459