Status:
TERMINATED
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
Lead Sponsor:
Gilead Sciences
Conditions:
Long QT Syndrome Type 3
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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....
Eligibility Criteria
Inclusion
- Key
- Individuals with an established diagnosis of LQT3 (by genotype testing)
- Mean (of triplicate) QTc interval ≥ 480 msec (or ≥ 460 msec, for individuals who are currently taking ranolazine or Class I antiarrhythmic drugs such as mexiletine) at 3 or more time points, determined by standard 12-lead ECG, at screening
- Key
Exclusion
- Known mutations associated with type 1 long QT syndrome (LQT1) or type 2 long QT syndrome (LQT2)
- Known or suspected history of seizures or epilepsy
- History of heart failure defined as New York Heart Association (NYHA) Class IV and/or known left ventricular ejection fraction (EF) ≤ 45%
- Body mass index (BMI) ≥ 40 kg/m\^2 at screening
- Severe renal impairment at screening (defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2, using the 4 Variable Modification of Diet in Renal Disease (MDRD) equation, as determined by the study center)
- Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN), or total bilirubin \> 1.5 x ULN
- An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD) implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to screening
- Any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02300558
Start Date
December 17 2014
End Date
February 15 2017
Last Update
January 12 2018
Active Locations (12)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
2
NYU Langone Medical Center
New York, New York, United States, 10016
3
University of Rochester Medical Center
Rochester, New York, United States, 14642
4
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7