Strategy for clinical trials evaluating QT prolongation by drugs without evident effect on ECG

THE CLINICAL EVALUATION OF QT/QTc INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS

Evaluating the pharmacodynamic effect of antimalarial drugs in clinical trials by quantitative PCR.

The ongoing development of new antimalarial drugs and the increasing use of controlled human malaria infection (CHMI) studies to investigate their activity in early-stage clinical trials require the development of methods to analyze their pharmacodynamic effect. This is especially so for studies where quantitative PCR (qPCR) is becoming the preferred method for assessing parasite clearance as t...

Policy Conference The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications

The Policy Conference on ‘The Potential for QT Prolongation and Proarrhythmia by Nonantiarrhythmic Drugs. Clinical and Regulatory Implications’ was held at the European Heart House in Sophia Antipolis, France, on the initiative of Günter Breithardt, FESC, FACC, on 24 and 25 June 1999 after formal approval by the Board of the European Society of Cardiology (ESC). The conference was organized und...

Medicines and QT Prolongation

Prolongation of the QT interval by ketanserin.

In hypertensive patients single doses of ketanserin 40 mg prolonged the corrected QT interval (QTc) for at least 8 hours, with a maximal increase of 35 ms (P less than 0.001, n = 6) after 2 hours. During chronic dosing (20 and 40 mg b.d.) the QTc was further prolonged, by 46 and 45 ms respectively. QTc prolongation after treatment with a mean dose of 73 mg/day for 7 weeks (n = 26) was significa...