Based on power analysis, a group size of approximately n = 18 per study arm is the minimal requirement in TQT studies to provide the sensitivity to detect a 5 ms QT interval prolongation.
As per the regular mandatory requirements, the study has been designed to undertake acute (single dose 10 days), sub-chronic (repeat dose 28 days) and chronic (intended clinical dose 120 days) toxicity tests using three dose levels viz.
The median lisinopril dosage requirements at month 24 of the study were 20 mg/day in females and 30 mg/day in males (80 mg/day maximum dose per study algorithm).
However, the number of requirements per contributing participant increased from 2.4 in the first study to 3.5 in the second study.
Information so gathered was suitably analyzed, validated, and adapted as per the requirements of the study.
The pooling of two jurisdictions (as per the funding requirements) for this study provides useful comparisons across the jurisdictions, especially as there are differing healthcare systems.
The number of requirements per contributing participant was considerably higher than the average of the other groups in Study II (7.3 compared to 3.5).
