Trial reportEuropean journal of clinical pharmacology2007
Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study.
Trial report in European journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
24 citing papers in PubMed, 71 citations in OpenAlex.
- No cardiac effects of therapeutic and supratherapeutic doses of rupatadine: results from a 'thorough QT/QTc study' performed according to ICH guidelines.British journal of clinical pharmacology · 2010Trial
- Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers.British journal of clinical pharmacology · 2010Trial
- High-risks drug adverse events associated with Cetirizine and Loratadine for the treatment of allergic diseases: A retrospective pharmacovigilance study based on the FDA adverse event reporting system database.Clinical and translational allergy · 2024Article
- Association between First-Generation Antihistamine Use in Children and Cardiac Arrhythmia and Ischemic Heart Disease: A Case-Crossover Study.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Evaluation of levocetirizine in beagle dog and cynomolgus monkey telemetry assays: Defining the no QTc effect profile by timepoint and concentration-QTc analysis.Clinical and translational science · 2023Article
- A quality-by-design eco-friendly UV-HPLC method for the determination of four drugs used to treat symptoms of common cold and COVID-19.Scientific reports · 2023Article
- Vonoprazan-associated long QT syndrome.Journal of general and family medicine · 2022Article
- Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver.The AAPS journal · 2020Article
- Application of a systems pharmacology model for translational prediction of hERG-mediated QTc prolongation.Pharmacology research & perspectives · 2016Article
- Balanced discussion of second-generation antihistamines' data.Therapeutics and clinical risk management · 2016Article
- The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project.Drug safety · 2016Article
- Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.Drug safety · 2015Article
- QT prolongation induced by hydroxyzine: a pharmacovigilance case report.European journal of clinical pharmacology · 2015Article
- Pro-arrhythmic potential of oral antihistamines (H1): combining adverse event reports with drug utilization data across Europe.PloS one · 2015Article
- Cardiovascular safety of antihistamines.Postepy dermatologii i alergologii · 2014Review
- The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2014Review
- Pharmacology of antihistamines.Indian journal of dermatology · 2013Article
- Update on the cardiac safety of moxifloxacin.Current drug safety · 2012Article
- Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies.Cancer chemotherapy and pharmacology · 2012Article
- Pharmacology of antihistamines.The World Allergy Organization journal · 2011Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo conduct a thorough QT study of levocetirizine, a non-sedating antihistamine, in accordance with International Conference on Harmonisation (ICH) E14 guidance.
methodsThe study was designed as a single-dose, placebo and positive-controlled, four-way crossover, randomised trial in which 52 healthy male and female subjects participated. Levocetirizine (5 and 30 mg) and placebo were administered double-blind, and the positive control, moxifloxacin (400 mg), was open-label. Electrocardiograms (ECGs) were obtained by continuous Holter monitoring at various time points (three per time point) during a 24-h period at baseline and after each treatment. The ECGs were read centrally in a blinded manner. QT intervals were corrected for heart rate using a gender- and study-specific correction (QTcSS) and Fridericia's correction (QTcF). The largest QTc time-matched and baseline-subtracted difference between each active drug and the placebo (largest delta delta QTcSS) was derived from a mixed-effect analysis of variance.
resultsThe one-sided 95% upper limits of the largest delta delta QTcSS for levocetirizine were 5.7 ms (5 mg) and 3.9 ms (30 mg), with mean estimates of 2.9 and 1.1 ms, respectively. Similar results were obtained for the delta delta QTcF data. Statistically, moxifloxacin significantly lengthened the QTcSS, with a one-sided 95% lower limit of the largest delta delta QTcSS of 10.5 ms and a mean estimate of 13.4 ms. There was no relationship between the measured delta QTcSS and the plasma concentration of levocetirizine, whereas a statistically significant linear relationship was observed with the plasma concentration of moxifloxacin [slope estimate 0.004 ms/(ng/mL); 95% confidence interval: 0.003-0.005].
conclusionsOverall, the results of this thorough QT study indicate that the methodology of the trial was valid and sensitive enough to demonstrate the absence of effect of levocetirizine at both therapeutic (5 mg) and supra-therapeutic (30 mg) doses on cardiac repolarisation.
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