Clinical Trial: Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome T

Brief Summary: This study will evaluate the effect of eleclazine on shortening of the corrected QT interval (QTc), safety, and tolerability in adults with type 3 long QT syndrome (LQT3). 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 phase.

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome: Difference between mean daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) interval at baseline and at Week 24 (based on standard 12-lead ECG data) [ Time Frame: Baseline; Week 24 ]

Original Primary Outcome: Difference between mean daytime QT interval corrected for heart rate (QTc) at baseline and at Week 24 (based on standard 12-lead ECG data) [ Time Frame: Baseline; Week 24 ]

Current Secondary Outcome:

  • Difference between the mean daytime QTcF interval at baseline and at Week 12 (based on standard 12-lead ECG data) [ Time Frame: Baseline; Week 12 ]
  • Difference between the mean daily QTcF interval at baseline and at Week 24 (based on Holter data) [ Time Frame: Baseline; Week 24 ]
  • Difference between the mean nocturnal QTcF interval at baseline and at Week 24 (based on Holter data) [ Time Frame: Baseline; Week 24 ]


Original Secondary Outcome:

  • Difference between the mean daily (24 hour) QTc interval at baseline and at Week 24 (based on Holter data) [ Time Frame: Baseline; Week 24 ]
  • Difference between the mean daytime QTc interval at baseline and at Week 12 (based on standard 12-lead ECG data) [ Time Frame: Baseline; Week 12 ]
  • Difference between the mean daily (24 hour) QTc interval at baseline and at Week 12 (based on Holter data) [ Time Frame: Baseline; Week 12 ]


Information By: Gilead Sciences

Dates:
Date Received: November 21, 2014
Date Started: December 17, 2014
Date Completion:
Last Updated: February 24, 2017
Last Verified: February 2017