Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01648205
Eligibility Criteria:
Inclusion Criteria:
* Genotyped positive for LQT3 (SCN5A) mutation
* Age 21 years or older
* Not currently taking an antiarrhythmic drug (beta blockers are allowed)
* Enrolled in LQTS Registry
Exclusion Criteria:
* Age less than 21 years
* Not confirmed to have an LQT3 mutation
* Significant co-morbidity that would preclude subject's safe participation in this study
* Females who are pregnant or nursing
* Females of childbearing age who are not using acceptable method of birth control
* Evidence of prior sensitivity to ranolazine
* Hepatic or renal disease that might adversely affect ranolazine excretion
* Currently taking strong CYP3A inhibitors
* Currently taking P-gp inhibitors
* Currently taking CYP3A inducers
* In vitro studies of specific mutation show no effect of ranolazine on late sodium current kinetics or show repolarization prolongation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01648205
Study Brief:
Protocol Section:
NCT01648205