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First received: January 27, 2023

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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