Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Long QT Syndrome Type 3
In brief
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.
Key facts
- Study ID
- NCT02300558
- Run by
- Gilead Sciences
- People needed
- 41
- Starts
- 2014-12-17
- Expected to finish
- 2017-02-15
- Last updated by the study team
- 2018-01-12
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- NYU Langone Medical Center — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
- L'institut Du Thorax Nantes — Nantes, France
- Groupe Hospitalier Bichat Claude Bernard — Paris, France
- CHU Réunion Sud — Saint-Pierre, France
- LMU Klinikum der Universität München — München, Germany
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
- Fondazione Salvatore Maugeri IRCCS — Pavia, Italy
- Academisch Medisch Centrum Amsterdam — Amsterdam, Netherlands
- Barts and The London School of Medicine and Dentistry — London, United Kingdom
Full record on ClinicalTrials.gov
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