Clinical Trial: Electrophysiological Effects of Potential QT Prolonging Drugs
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Drug-induced QT Prolongation
Study Type: INTERVENTIONAL
Official Title: Clinical ECG Study to Evaluate Electrophysiological Effects of Potential QT Prolonging Drugs With Novel ECG Biomarkers With Exposure-Response Analysis
Brief Summary:
Since 2005, FDA has required almost all new drugs be tested for their ability to prolong the QT interval through clinical studies.This requirement stems from the increased TdP risk QT interval prolongation can cause.However, the QT interval is an imperfect biomarker, as there are multiple drugs that can prolong the QT interval, without causing increased TdP occurrence.As such, numerous drugs labeled as causing QT prolongation, may in fact have no impact on TdP occurrence.To address this problem, FDA, in…
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