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Trial record 43 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

Effect of Eleclazine on QT, Safety, and Tolerability in Adults With Long QT2 Syndrome

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ClinicalTrials.gov Identifier: NCT02365506
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
LQT2 Syndrome Drug: Eleclazine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Effect of GS-6615 on QT, Safety and Tolerability in Subjects With Long QT2 Syndrome
Study Start Date : July 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Eleclazine Dose Level 1
Eleclazine dose level 1 + placebo to match eleclazine
Drug: Eleclazine
Eleclazine tablets administered orally
Other Name: GS-6615

Drug: Placebo
Placebo to match eleclazine tablets administered orally

Experimental: Eleclazine Dose Level 2
Eleclazine dose level 2 + placebo to match eleclazine
Drug: Eleclazine
Eleclazine tablets administered orally
Other Name: GS-6615

Drug: Placebo
Placebo to match eleclazine tablets administered orally

Placebo Comparator: Placebo
Placebo to match eleclazine for 4 days
Drug: Placebo
Placebo to match eleclazine tablets administered orally




Primary Outcome Measures :
  1. Change in daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) [ Time Frame: Up to 3 days ]

Secondary Outcome Measures :
  1. Change in daily QT interval [ Time Frame: Up to 3 days ]
  2. Maximal QT shortening [ Time Frame: Up to 3 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365506


Locations
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United States, New York
University of Rochester Medical Center/Strong Memorial Hospital
Rochester, New York, United States, 14620
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Jennifer Hellawell, MD, FACC Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02365506     History of Changes
Other Study ID Numbers: GS-US-394-1658
2015-002413-30 ( EudraCT Number )
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Gilead Sciences:
Congenital Long QT Syndrome
LQTS
Long QT2 Syndrome
LQT2
Sudden Cardiac Death

Additional relevant MeSH terms:
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Long QT Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities