drugset / Trial / NCT02300558

Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3

NCT02300558

Phase 3 Terminated 41 enrolled Gilead Sciences
Non-randomizedSingle-groupSingle-blindTreatment

Summary

The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

Timeline

Start
2014-12-17
Primary completion
2016-12-12
Completion
2017-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Eleclazine Small molecule Oral

Indications