[c09aa8]: / clusters / 9knumclustersv2 / clust_2954.txt

Download this file

9 lines (8 with data), 7.2 kB

1
2
3
4
5
6
7
8
Clinically significant, uncontrolled heart diseases\r\n* Unstable angina within months prior to screening\r\n* Myocardial infarction within months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without antihypertensive medication; initiation or adjustment of antihypertensive medication (s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Fridericia's correction formula (QTcF) > msec
Patients with clinically significant, uncontrolled cardiovascular disease, such as:\r\n* Unstable angina within months prior to screening\r\n* Myocardial infarction within months prior to screening\r\n* Patients with a history of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Peripheral vascular disease\r\n* Patients with uncontrolled hypertension defined as a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without anti-hypertensive medication; initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Patients with corrected QT (QTc) >= ms (male patients) or >= ms (female patients) using Fridericia correction (QTcF) on the screening electrocardiogram (ECG)\r\n* Patients with history of congenital long QT syndrome or history of torsade de pointes
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within months), such as:\r\n* Unstable angina within months prior to screening?\r\n* Myocardial infarction within months prior to screening?\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV);\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without antihypertensive medication.\r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening?\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication?\r\n* Other cardiac arrhythmia not controlled with medication?\r\n* Corrected QT (QTcF) > ms using Fridericias correction on the screening electrocardiography (ECG)
Clinically significant, uncontrolled heart disease and/or recent cardiac event (within months), such as:\r\n* Unstable angina\r\n* Myocardial infarction\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without antihypertensive medication\r\n* Ventricular arrhythmias, or supraventricular/nodal arrhythmias not controlled with medications; other cardiac arrhythmias not controlled with medications\r\n* Left ventricular ejection fraction < % corrected QT (QTcF) > ms using Fridericias correction on the screening electrocardiogram (ECG)\r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within months), such as:\r\n* Unstable angina within months prior to screening\r\n* Myocardial infarction within months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without antihypertensive medication \r\n** Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QT (QTcF) > ms using Fridericias correction on the screening electrocardiogram (ECG)
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within months), such as: \r\n* Unstable angina within months prior to screening\r\n* Myocardial infarction within months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mmHg and/or diastolic blood pressure (DBP) >= mmHg, with or without antihypertensive medication - initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QT interval (QTc) > msec using Fridericia correction on the screening electrocardiogram (ECG)
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within months), such as:\r\n* Unstable angina within months prior to screening\r\n* Myocardial infarction within months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without antihypertensive medication \r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QTcF > msec using Fridericia correction on the screening electrocardiogram (ECG)
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study; impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Unstable angina within months prior to screening\r\n* Myocardial infarction within months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III - IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= mm Hg and/or diastolic blood pressure (DBP) >= mm Hg, with or without antihypertensive medication\r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QT (QTc) > msec using Fridericia correction on the screening electrocardiogram (ECG)