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

NCT02300558 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-01-12

Study results available
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Summary

The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. 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 (OLE) phase.

Conditions

  • Long QT Syndrome Type 3

Interventions

DRUG

Eleclazine

Tablets administered orally

DRUG

Eleclazine placebo

Tablets administered orally

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-12-17
Primary Completion
2016-12-12
Completion
2017-02-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT02300558 on ClinicalTrials.gov