History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks.
Acute coronary syndrome within 6 months prior to starting treatment
Recent (within 6 months) history of second degree (Type II) or third degree atrioventricular (AV) block cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting, or bypass grafting; Class II, III, or IV heart failure, or symptomatic pericarditis.
Acute coronary syndrome
Cardiac abnormalities:\r\n* Mean QTc interval >= 480 msec at screening\r\n* Acute coronary syndrome (ACS)/acute myocardial infarction (AMI) –within 24 weeks prior to screening\r\n* Percutaneous coronary intervention (PCI)/percutaneous transluminal coronary angioplasty (PTCA) –within 24 weeks prior to screening\r\n* Symptomatic heart failure – New York Heart Association (NYHA) class >= II symptoms
Clinically significant, uncontrolled heart disease and/or recent events including any of the following:\r\n* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting\r\n* Coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy\r\n* Patient has a left ventricular ejection fraction < 40% as determined by multigated acquisition (MUGA) scan or echocardiography (ECHO) (MUGA and ECHO are not required prior to enrollment)
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stent placement within 6 months prior to study drug dosing
Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months
Significant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 months
History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration.
Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 months
History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.
Myocardial infarction, stroke, coronary artery bypass surgery, coronary stent, or unstable angina within one year are excluded; Note: A subject may enroll in the study and have a start date set in the near future in a way that meets the timelines for exclusion items by the treatment start date
Significant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 months
history of acute coronary syndromes (including unstable angina)
Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\r\n* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to screening\r\n* Symptomatic chronic heart failure; evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia
Coronary/peripheral artery bypass graft
Has significant cardiac conduction abnormalities and/ or pacemaker or any of the following criteria:\r\n* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft [CABG], coronary angioplasty, or stenting) < 6 months prior to screening\r\n* Symptomatic chronic heart failure; evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening\r\n* Uncontrolled arterial hypertension, defined as blood pressure (BP) > 140/100 mmHg (average of 3 consecutive readings)
Patients have clinically significant cardiovascular disease, including any of the following: \r\n* History of acute coronary syndrome including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty or stenting < 6 months prior to screening\r\n* Symptomatic chronic heart failure (New York Heart Association criteria, class II-IV)\r\n* Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT)
Patient do not have adequate cardiac function defined as:\r\n* Left ventricular ejection fraction (LVEF) =< 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram\r\n* Corrected QT (QTc) interval >= 480 ms\r\n* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting [CABG], coronary angioplasty, or stenting) < 6 months prior to screening\r\n* Symptomatic chronic heart failure; evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening
Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.
History of myocardial infarction, acute coronary syndromes or coronary angioplasty/stenting/bypass grafting within the past 6 months.
History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following within 6 months of enrollment: myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting, symptomatic chronic heart failure, clinically significant cardiac arrhythmias and/or conduction (except atrial fibrillation and paroxysmal supraventricular tachycardia)
Active cardiac disease defined as unstable angina, uncontrolled hypertension, myocardial infarction in the last six months (unless successfully treated with coronary artery bypass grafting [CABG] or percutaneous transluminal coronary angioplasty [PTCA]), uncontrolled arrhythmia, or symptomatic congestive heart failure; > 3 heart-related hospitalizations in the past year
History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment
History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft, coronary angioplasty, or stenting) < 6 months prior to screening
Impaired cardiovascular function or clinically specific cardiovascular disease including any of the following:\r\n* History of acute coronary syndromes (including myocardial infarction unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) =< 6 months; OR\r\n* Symptomatic chronic heart failure history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to screening; except atrial fibrillation and paroxysmal supraventricular tachycardia
Patients who have had either myocardial infarction, coronary artery bypass graft, coronary artery stenting, hospital admission for heart related issues such as congestive heart failure or arrhythmia within the last 3 months, will not be allowed on protocol
Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis
Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis
Subject has a high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
Coronary/peripheral artery bypass graft
History of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry
Active cardiac disease defined as unstable angina, uncontrolled hypertension, myocardial infarction in the last six months (unless successfully treated with coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]), uncontrolled arrhythmia, or congestive heart failure; > 3 heart-related hospitalization in the past year
History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screening
Patients have clinically significant cardiovascular disease, including any of the following \r\n* Any history of acute coronary syndrome including myocardial infarction, stable or unstable angina, coronary artery bypass grafting (CABG), coronary angioplasty or stenting, or known obstructive coronary artery disease\r\n* Symptomatic chronic heart failure (New York Heart Association criteria, class II-IV) \r\n* Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT)
History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment.
History or evidence of cardiovascular risk including any of the following -- History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment. Additional Exclusion Criteria for Part E
History or evidence of cardiac risk, including:\r\n* Corrected QT interval on screening electrocardiogram (ECG) > 470 msec\r\n* Left ventricular ejection fraction (LVEF) < 50%\r\n* Clinically significant uncontrolled arrhythmias or arrhythmia requiring treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia\r\n* History of acute coronary syndromes within 6 months prior to the first dose of study therapy (including myocardial infarction and unstable angina, coronary artery bypass graft, angioplasty, or stenting)
Patients have clinically significant cardiovascular disease, including any of the following:\r\n* History of acute coronary syndrome including myocardial infarction, unstable angina, coronary artery bypass surgery (CABG), coronary angioplasty or stenting < 6 months prior to screening\r\n* Symptomatic chronic heart failure (New York Heart Association Criteria, class II-IV)\r\n* Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT)
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, and/or stenting up to 12 weeks before Cycle 1, Day
Stroke, transient ischemic attack, arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within the past 6 months
History of acute coronary syndromes (specifically, myocardial infarction and unstable angina), severe/unstable angina, coronary angioplasty, or stenting within 6 months prior to the initiation of therapy on this protocol
Coronary artery bypass graft surgery
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or coronary artery stenting within the past 6 months
History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to study enrollment
History of any of the following coronary conditions within 90 days of planned tadalafil administration:\r\n* Myocardial Infarction\r\n* Coronary artery bypass graft surgery\r\n* Percutaneous coronary intervention (for example, angioplasty or stent placement)\r\n* Any evidence of heart disease (New York Heart Association [NYHA] >= class III) within 6 months of planned tadalafil administration
Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months
Known myocardial infarction, severe/unstable angina, percutaneous transluminal coronary angioplasty/stenting (PTCA), or coronary artery bypass graft (CABG) within 6 month of the first dose of the study treatment
Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\r\n* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting [CABG], coronary angioplasty, or stenting) < 6 months prior to screening\r\n* Symptomatic chronic heart failure\r\n* Evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia
High cardiovascular risk, including but not limited to, recent coronary stenting or myocardial infarction in the past year
Myocardial infarction, unstable angina, coronary artery bypass graft, coronary artery angioplasty or stent placement within 12 months before scheduled dosing day 1;
Active coronary artery disease, defined as myocardial infarction, unstable angina, coronary bypass graft, or stenting within 6 months prior to study entry
A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting [CABG], coronary angioplasty, or stenting) < 6 months prior to screening
A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
Coronary angioplasty or stenting within the past 12 weeks
Coronary or peripheral artery bypass graft within 6 months of screening
Recent acute coronary syndrome (ACS)/acute myocardial infarction (AMI) – defined as within 24 weeks prior to screening
Recent percutaneous coronary intervention (PCI)/percutaneous transluminal coronary angioplasty (PTCA) – defined as within 24 weeks prior to screening
A history (within 6 months prior to first dose of study treatment) of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty
History of acute coronary syndromes.
History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
Acute coronary syndrome
Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:\r\n* History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to screening,\r\n* Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia
No unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
Acute Coronary Syndrome (ACS) (angina or MI) in last 6 months.
Acute coronary (e.g. myocardial infarction) or vascular event within the last year as well as uncontrolled coronary heart disease (e.g. progressive angina)
Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years
Patients who have experienced an acute coronary syndrome or angina in the past 6 months
Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years
Significant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 months
Acute myocardial infarctions or acute coronary syndromes