Expired Study
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Rochester, New York 14620


Purpose:

This study will evaluate the effect of oral eleclazine (GS-6615) on QTc interval, safety, and tolerability in adults with long QT2 syndrome.


Criteria:

Inclusion Criteria: - Individuals with an established diagnosis of LQT2 (by genotype testing) - Mean (of triplicate) QTc interval ≥ 480 msec for at least four out of seven time points, determined by standard 12-lead ECG, at screening Exclusion Criteria: - Known mutations associated with LQT1 or LQT3 - 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) ≥ 36 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


NCT ID:

NCT02365506


Primary Contact:

Study Director
Jennifer Hellawell, MD, FACC
Gilead Sciences


Backup Contact:

N/A


Location Contact:

Rochester, New York 14620
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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