On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); all as determined by screening ECG (mean of triplicate ECGs)
Standard 12-lead electrocardiography (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Fridericia's correction formula (QTcF) interval at screening < 450 msec (using Fridericia’ s correction)\r\n* Resting heart rate 50 to 100 beats per minute
Patients must have at screening a standard 12-lead electrocardiogram (ECG) with mean values that meet the following parameters:\r\n* Fridericia's correction QT (QtcF) interval at screening < 450 msec (using Fridericia’s correction)\r\n* Resting heart rate of 50-90 beats per minute (bpm)
On screening inability to determine the corrected QT using Fridericia's formula (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); all as determined by screening ECG (mean of triplicate ECGs)
Patient with standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Fridericia's correction formula (QTcF) interval at screening < 450 msec (using Fridericia’s correction)
QT interval with Fridericia's correction [QTcF] >470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
Screening electrocardiogram (ECG) (defined as the mean of the triplicate ECGs) with QTcF interval at screening =< 450 msec (using Fridericia’s correction) and resting heart rate >= 50 bpm
Meets the following standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Corrected QT using Fridericia's correction formula (QTcF) interval at screening < 450 msec for males and < 470 msec for females\r\n* Resting heart rate =< 100 beats per minute (bpm)
Patients with available standard 12-lead electrocardiography (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Fridericia's correction formula (QTcF) interval at screening < 450 msec\r\n* Resting heart rate 50-90 beats per minute (bpm)
Patient with available standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* Corrected QT interval using Fridericia's formula (QTcF) at screening < 450 msec (using Fridericia’s correction)\r\n* Resting heart rate 50-90 bpm
Standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):\r\n* QT corrected by Fridericia's formula (QTcF) interval at screening < 450msec (using Fridericia’s correction)
Fridericia's correction formula (QTcF) interval on standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs) of < 450 msec for males and < 470 msec for females
QTcF interval ?450 msec using the mean of triplicate electrocardiograms (ECGs).
On screening, inability to determine the Fridericia corrected QT interval (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); all as determined by screening ECG (mean of triplicate ECGs)
A QTc interval of >470 msec by the Fridericia formula (QTcF), at the Screening ECG. If the subject's QTcF is >470 msec on the initial ECG, a total of 3 ECGs should be obtained at least 3 minutes apart and all within 30 minutes. The average of the 3 QTcF's will be used to determine eligibility. Known or suspected causes of prolonged QTc can be treated (e.g., hypocalcemia, hypokalemia, hypomagnesimia) and the ECGs may be repeated. If the subject initiates treatment with a drug known to prolong the QTc during the Screening period after the initial Screening ECGs were obtained, the Screening ECGs must be repeated once the new drug has reached steady state to ensure the average QTcF remains ?470 msec. For subject's whose heart rate is <60 bpm, the Bazett correction formula (QTcB) may be used.
Inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF > 450 msec (using Fridericia’s correction); NOTE: all as determined by screening ECG
Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory.
QTcF > 460 msec on screening Electrocardiography (ECG) (mean of triplicate recordings).
Inability to determine the QTcF interval on the ECG (i.e. unreadable or not interpretable) or QTcF > 450 msec (using Fridericia's correction). All as determined by screening ECG (using the mean QTcF of triplicate ECGs)
On screening, inability to determine the Fridericia's corrected QT (QTcF) interval on the ECG (i.e.: unreadable or not interpretable) or QTcF> 450 msec (using Fridericia’s correction); all as determined by screening ECG
Patient with available standard 12-lead electrocardiography (ECG) with the following parameters at screening: a. Corrected QT interval by Fridericia's formula (QTcF) interval at screening < 450 msec (using Fridericia’s correction). b. Resting heart rate 50-100 beats per minute (bpm).
Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value.
QT (Interval from the beginning of the QRS complex to the end of the T wave on an electrocardiogram) interval with Fridericia's correction [QTcF] >450 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
QTcF greater than 460 msec on Screening ECG (mean of triplicate recordings)
QTcF > 470 msec on Screening ECG (mean of triplicate recordings).
Uncontrolled or severe cardiovascular disease, including myocardial infarction, unstable angina, or atrial fibrillation (AFib) within 6 months prior to study treatment, New York Heart Association (NYHA) class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, cardiac amyloidosis, or corrected QT (QTc) with Fridericia’s (QTcF) correction that is unmeasurable or >= 480 msec on screening electrocardiography (ECG); (Note: for QTcF >= 480 sec on the screening ECG, the ECG may be repeated twice at least 24 hours apart; the mean QTcF from the three screening ECGs must be < 480 msec in order to meet eligibility for trial participation)