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, Gilead Sciences; results first posted 2018-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3. Trials, record NCT02300558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02300558
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
- NCT number
- NCT02300558
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Long QT Syndrome Type 3
- Interventions
- Eleclazine, Eleclazine placebo
- First posted
- 2014-11-25
- Last updated
- 2018-01-12
- Other registries' IDs
- eudract:2014-000042-30
- Results first posted
- 2018-01-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data) | Baseline; Week 24 | * 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. |
| Secondary | Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG) | Baseline; Week 12 | * 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. |
| Secondary | Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter) | Baseline; Week 24 | * 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. * Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from predose to 6 hours postdose. Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM. Daily was computed as the average of daytime (AUC0-6/6) and nocturnal (AUC0-6/6), with both values required to compute the average. |
| Secondary | Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter) | Baseline; Week 24 | * 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. * Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data) | Baseline; Week 24 | Participants in Full Analysis Set (FAS) with available data were analyzed. FAS was defined as all enrolled participants who have confirmed LQT3 genotype, do not have confirmed LQT1 or LQT2 mutations, received at least 1 dose of active eleclazine, and have both a baseline and at least 1 postbaseline mean daytime QTcF interval (standard 12-lead). | msec | MEAN |
| SECONDARY | Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG) | Baseline; Week 12 | Participants in the Full Analysis Set with available data were analyzed. | msec | MEAN |
| SECONDARY | Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter) | Baseline; Week 24 | Participants in the Full Analysis Set with available data were analyzed. | msec | MEAN |
| SECONDARY | Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter) | Baseline; Week 24 | Participants in the the Full Analysis Set with available data were analyzed. | msec | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data) | Eleclazine | -8.5 | Standard Deviation 18.03 | msec | |
| Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG) | Eleclazine | 2.2 | 95% Confidence Interval -4.7 to 9.2 | msec | |
| Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter) | Eleclazine | -1.8 | 95% Confidence Interval -13.6 to 10.0 | msec | |
| Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter) | Eleclazine | -3.0 | 95% Confidence Interval -17.1 to 11.0 | msec |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single Blind Phase (24 Weeks) | STARTED | Eleclazine | 41 | |
| Single Blind Phase (24 Weeks) | COMPLETED | Eleclazine | 35 | |
| Single Blind Phase (24 Weeks) | NOT COMPLETED | Eleclazine | 6 | |
| Open-Label (OL) Extension Phase | STARTED | Eleclazine | 32 | |
| Open-Label (OL) Extension Phase | COMPLETED | Eleclazine | 0 | |
| Open-Label (OL) Extension Phase | NOT COMPLETED | Eleclazine | 32 |
Source ClinicalTrials.gov
Adverse events65
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 41 | |
| other | Vertigo | Ear and labyrinth disorders | Eleclazine Loading Dose (LD) 48 mg | 2 | 41 | |
| other | Vertigo | Ear and labyrinth disorders | Eleclazine Maintenance Dose (MD) 3 mg | 0 | 41 | |
| other | Vertigo | Ear and labyrinth disorders | Eleclazine MD 6 mg | 2 | 41 | |
| other | Vertigo | Ear and labyrinth disorders | All Eleclazine | 3 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Eleclazine Loading Dose (LD) 48 mg | 0 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Eleclazine Maintenance Dose (MD) 3 mg | 3 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Eleclazine MD 6 mg | 1 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | All Eleclazine | 4 | 41 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 41 |
| Total, all-cause mortality | Eleclazine Loading Dose (LD) 48 mg | 0 | 41 |
| Total, all-cause mortality | Eleclazine Maintenance Dose (MD) 3 mg | 0 | 41 |
| Total, all-cause mortality | Eleclazine MD 6 mg | 0 | 41 |
| Total, all-cause mortality | All Eleclazine | 0 | 41 |
| Total, other adverse events | Placebo | 5 | 41 |
| Total, other adverse events | Eleclazine Loading Dose (LD) 48 mg | 5 | 41 |
| Total, other adverse events | Eleclazine Maintenance Dose (MD) 3 mg | 17 | 41 |
| Total, other adverse events | Eleclazine MD 6 mg | 14 | 41 |
| Total, other adverse events | All Eleclazine | 24 | 41 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02300558
GET https://conductscience.org/api/trials/v1/NCT02300558/events?page=2