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

NCT02104583 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2019-04-09

Study results available
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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

DRUG

Eleclazine

Eleclazine tablets administered orally

DRUG

Placebo to match eleclazine

Placebo to match eleclazine tablets administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104583 on ClinicalTrials.gov