Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
149
Average QTcF (QT interval Fridericia correction) change
Time frame: baseline, day 1, day 7
Change in QT interval
Time frame: baseline, day 1, day 7
Change in QTcB (QT interval Bazett correction) interval
Time frame: baseline, day 1, day 7
Change in PQ interval
Time frame: baseline, day 1, day 7
Change in QRS interval
Time frame: baseline, day 1, day 7
Change in RR interval
Time frame: baseline, day 1, day 7
Change in heart rate (HR)
Time frame: baseline, day 1, day 7
Occurrence of ECG abnormalities
Time frame: baseline, day 1, day 7
Change in T wave morphology
normal, flat, inverted, biphasic
Time frame: baseline, day 1, day 7
Change in U wave morphology
normal, abnormal
Time frame: baseline, day 1, day 7
Area under the plasma concentration time curve (AUC)
Time frame: day 1, day 7
Maximum plasma concentration (Cmax)
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Time frame: day 1, day 7
Time to attain maximum plasma concentration (tmax)
Time frame: day 1, day 7
Trough plasma concentration at steady state (Cmin,ss)
Time frame: day 7
Number of participants with adverse events
Time frame: up to 8 days after last treatment