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NCT02300558 · ClinicalTrials.gov registry record · Phase 3
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT02300558: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT02300558 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02300558, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study 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.
Primary Outcome
* Baseline was the Day 1 value. * QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds. * AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times). * Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point.
Interventions
- DRUG Eleclazine
- DRUG Eleclazine placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2017-02-15 |
| Phase | Phase 3 |
Why NCT02300558 stopped before completion
NCT02300558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Eleclazine is the first listed.
NCT02300558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02300558 about?
NCT02300558 is a clinical study titled "Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3". 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 el...
What is the current status of trial NCT02300558?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2014-12-17. Estimated completion is 2017-02-15.
What interventions are being tested in trial NCT02300558?
The interventions under investigation include: Eleclazine (DRUG), Eleclazine placebo (DRUG).
Who is sponsoring clinical trial NCT02300558?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02300558's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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