NCT02104583

Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ventricular Arrhythmia

Interventions

Type	Name	Description
DRUG	Eleclazine	Eleclazine tablets administered orally
DRUG	Placebo to match eleclazine	Placebo to match eleclazine tablets administered orally

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2014-04-04
• Last updated: 2019-04-09
• Results posted: 2019-04-09

Locations

84 sites across 9 countries: United States, Canada, Czechia, Denmark, Germany, Hungary, Israel, Netherlands, Poland