At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 313 enrolled
Drug / intervention
Eleclazine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects With Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
In Brief
A Phase 2 clinical trial evaluating Eleclazine and Placebo to match eleclazine for Ventricular Arrhythmia. Completed, enrolled 313 participants across 84 sites in 9 countries.
Detailed Summary
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing \[ATP\] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Arrhythmia
CountriesCanada, Czechia, Denmark, Germany, Hungary, Israel, Netherlands, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartSep 2014
Primary CompletionSep 2016
Study CompletionOct 2016
TodayJul 2026
First PostedApr 4, 2014
Enrollment StartSep 1, 2014
Primary CompletionSep 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.2 years ago
Interventions
Eleclazinedrug
Eleclazine tablets administered orally
Placebo to match eleclazinedrug
Placebo to match eleclazine tablets administered orally