Effect of nalmefene 20 and 80 mg on the corrected QT interval and T-wave morphology: a randomized, double-blind, parallel-group, placebo- and moxifloxacin-controlled, single-centre study
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Effect of nalmefene 20 and 80 mg on the corrected QT interval and T-wave morphology : a randomized, double-blind, parallel-group, placebo- and moxifloxacin-controlled, single-centre study. / Matz, Jørgen; Graff, Claus; Vainio, Petri J.; Kallio, Antero; Højer, Astrid Maria; Struijk, Johannes J.; Kanters, Jørgen K.; Andersen, Mads Peter; Toft, Egon.
I: Clinical Drug Investigation, Bind 31, Nr. 11, 2011, s. 799-811.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Effect of nalmefene 20 and 80 mg on the corrected QT interval and T-wave morphology
T2 - a randomized, double-blind, parallel-group, placebo- and moxifloxacin-controlled, single-centre study
AU - Matz, Jørgen
AU - Graff, Claus
AU - Vainio, Petri J.
AU - Kallio, Antero
AU - Højer, Astrid Maria
AU - Struijk, Johannes J.
AU - Kanters, Jørgen K.
AU - Andersen, Mads Peter
AU - Toft, Egon
PY - 2011
Y1 - 2011
N2 - Nalmefene is an orally administered competitive opioid receptor antagonist targeted at reducing alcohol consumption in alcohol-dependent patients. As part of the regulatory requirements for drug approval, the potential of novel compounds for causing unwanted proarrhythmia should be studied in a thoroughly designed clinical QT/corrected QT (QTc) study (International Conference on Harmonisation [ICH] E14 guideline).
AB - Nalmefene is an orally administered competitive opioid receptor antagonist targeted at reducing alcohol consumption in alcohol-dependent patients. As part of the regulatory requirements for drug approval, the potential of novel compounds for causing unwanted proarrhythmia should be studied in a thoroughly designed clinical QT/corrected QT (QTc) study (International Conference on Harmonisation [ICH] E14 guideline).
KW - Adult
KW - Anti-Infective Agents
KW - Arrhythmias, Cardiac
KW - Aza Compounds
KW - Biomarkers, Pharmacological
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Electrocardiography
KW - Female
KW - Guidelines as Topic
KW - Heart Rate
KW - Humans
KW - Long QT Syndrome
KW - Male
KW - Naltrexone
KW - Narcotic Antagonists
KW - Placebos
KW - Prospective Studies
KW - Quinolines
KW - Treatment Outcome
KW - Young Adult
U2 - 10.1007/BF03256919
DO - 10.1007/BF03256919
M3 - Journal article
C2 - 21967071
VL - 31
SP - 799
EP - 811
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
SN - 1173-2563
IS - 11
ER -
ID: 48052162