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

Standard

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.

I: Clinical Drug Investigation, Bind 32, Nr. 5, 01.05.2012, s. 339-51.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Graff, C, Struijk, JJ, Kanters, JK, Andersen, MP, Toft, E & Tyl, B 2012, 'Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study', Clinical Drug Investigation, bind 32, nr. 5, s. 339-51. https://doi.org/10.2165/11599270-000000000-00000

APA

Graff, C., Struijk, J. J., Kanters, J. K., Andersen, M. P., Toft, E., & Tyl, B. (2012). Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clinical Drug Investigation, 32(5), 339-51. https://doi.org/10.2165/11599270-000000000-00000

Vancouver

Graff C, Struijk JJ, Kanters JK, Andersen MP, Toft E, Tyl B. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clinical Drug Investigation. 2012 maj 1;32(5):339-51. https://doi.org/10.2165/11599270-000000000-00000

Author

Graff, Claus ; Struijk, Johannes J. ; Kanters, Jørgen K. ; Andersen, Mads Peter ; Toft, Egon ; Tyl, Benoît. / Effects of bilastine on T-wave morphology and the QTc interval : a randomized, double-blind, placebo-controlled, thorough QTc study. I: Clinical Drug Investigation. 2012 ; Bind 32, Nr. 5. s. 339-51.

Bibtex

@article{6e314deaf35d472081994f471594e344,
title = "Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study",
abstract = "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.",
keywords = "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",
author = "Claus Graff and Struijk, {Johannes J.} and Kanters, {J{\o}rgen K.} and Andersen, {Mads Peter} and Egon Toft and Beno{\^i}t Tyl",
year = "2012",
month = may,
day = "1",
doi = "10.2165/11599270-000000000-00000",
language = "English",
volume = "32",
pages = "339--51",
journal = "Clinical Drug Investigation",
issn = "1173-2563",
publisher = "Adis International Ltd",
number = "5",

}

RIS

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