Subjects with any of the following cardiovascular conditions within the past months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible Patients who have experienced any of the following procedures or conditions currently or in the preceding months: coronary artery bypass graft, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association Grade ?, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any other central nervous system bleeding. Patients with a history of any one or more of the following cardiovascular conditions within the past months prior to study enrollment are NOT eligible for participation:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any of the following cardiovascular conditions within months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association Patient must not have a history of the following within months prior to cycle day : a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder Had any of the following within months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV) History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Other serious illness or medical condition within months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke. History of the following within the prior months: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder Clinically significant atherosclerotic cardiovascular disease including patients with New York Heart class II/III/IV congestive heart failure (CHF), ventricular arrhythmias requiring medication, myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary artery bypass grafting, angioplasty, cardiac or other vascular stenting within the past months History of any one or more of the following cardiovascular conditions within the past months: cardiac angioplasty or stenting, myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure as defined by the New York Heart Association History of any one or more of the following cardiovascular conditions within the past months: \r\n* Cardiac angioplasty or stenting \r\n* Myocardial infarction \r\n* Unstable angina \r\n* Coronary artery bypass graft surgery \r\n* Symptomatic peripheral vascular disease Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within months prior to administration of first dose of study drug. History of any of the following cardiovascular conditions within months of enrollment: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, class III or IV congestive heart failure as defined by the New York Heart Association, symptomatic peripheral vascular disease, cerebrovascular accident, or transient ischemic attack Patients with a significant history of cardiovascular disease or procedures within the preceding months (e.g., myocardial infarction [MI], coronary artery bypass graft placement, angioplasty, vascular stent, angina pectoris, ventricular arrhythmias requiring continuous therapy, congestive heart failure New York Heart Association [NYHA] grade >= , thrombotic or thromboembolic event) History of any of the following cardiovascular conditions within months of screening:\r\n* Myocardial infarction\r\n* Unstable angina pectoris\r\n* Cardiac angioplasty or stenting\r\n* Coronary/peripheral artery bypass graft\r\n* Class III or IV congestive heart failure per New York Heart Association\r\n* Cerebrovascular accident or transient ischemic attack Any of the following conditions =< weeks prior to registration:\r\n* Cerebrovascular accident (CVA)\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting or coronary artery bypass graft surgery\r\n* Untreated pulmonary embolism or untreated deep venous thrombosis (DVT)\r\n* Arterial thrombosis\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system Subjects with any of the following cardiovascular conditions within the past months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Admission for unstable angina\r\n* Myocardial infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible\r\n* Active cardiac arrhythmia (except sinus arrhythmia, atrial fibrillation, asymptomatic premature ventricular contractions [PVCs])\r\n* Ejection fraction < institutional lower limit of normal (LLN) and/or history of cardiomyopathy Patients with any of the following cardiovascular conditions within the past months:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Admission for unstable angina\r\n* Myocardial Infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT), or DVT which has been treated with therapeutic anticoagulation for less than weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Note: a patient who has a history of class III heart failure and is asymptomatic on treatment may be considered eligible for the study History of the following within months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.. Treatment with any investigational product within days prior to signing Informed Consent Form. History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral arterial vascular disease History of any one or more of the following cardiovascular conditions within the past months: cardiac angioplasty or stenting, myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure as defined by the New York Heart Association Any of the following within months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV. Patients who have experienced any of the following procedures or conditions currently or in the preceding months:\r\n* Coronary artery bypass graft\r\n* Angioplasty\r\n* Vascular stent\r\n* Myocardial infarction\r\n* Angina pectoris\r\n* Congestive heart failure New York Heart Association grade >= (ventricular arrhythmias requiring continuous therapy)\r\n* Supraventricular arrhythmias including atrial fibrillation, which are uncontrolled\r\n* Hemorrhagic or thrombotic stroke, including transient ischemic attacks or any other central nervous system bleeding\r\n* History of drug abuse or alcohol abuse, as judged by the investigator Patients who have experienced any of the following procedures or conditions currently or in the preceding months: a) coronary artery bypass graft; b) angioplasty; c) vascular stent; d) myocardial infarction; e) angina pectoris; f) congestive heart failure New York Heart Association grade >= ; g) ventricular arrhythmias requiring continuous therapy; h) supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; i) hemorrhagic or thrombotic stroke, including transient ischemic attacks or any other central nervous system bleeding Coronary artery bypass graft surgery History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any of the following coronary conditions within 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 months of planned tadalafil administration History of any one or more of the following conditions within months of registration:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Pneumonitis History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease History of any one or more of the following cardiovascular conditions within the past months:\r\n* Angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery by-pass graft surgery\r\n* Symptomatic peripheral vascular disease Subjects with any of the following cardiovascular conditions within the past months:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of Class II heart failure\tand is asymptomatic on treatment may be considered eligible History of any one or more of the following cardiovascular conditions within the past months: \r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina \r\n* Coronary artery bypass graft surgery \r\n* Symptomatic peripheral vascular disease \r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) E . Any of the following within months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack. Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV. Uncontrolled CHF (NYHA Class -), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior months; Subject has a history of a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, seizure disorder or clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, within months prior to Cycle Day . History of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) History of the following within months prior to first administration of investigational product: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder. Any of the following within months prior to study entry: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack Participants with history of cardiovascular disease manifested as:\r\n* History of myocardial infarction\r\n* Unstable angina\r\n* Currently taking medication for treatment of angina\r\n* History of coronary artery bypass surgery\r\n* New York Heart Association class or heart failure Cardiovascular events, such as myocardial infarction, unstable/severe angina, coronary/peripheral artery bypass graft, unstable cardiac arrhythmia requiring medication, congestive heart failure (NYHA > class II), within years History of any one or more of the following cardiovascular conditions within the past months: cardiac angioplasty or stenting; myocardial infarction; unstable angina; coronary artery bypass graft surgery; symptomatic peripheral vascular disease; class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Patients must not have history of any one or more of the following cardiovascular conditions within the past months:\r\n* Cardiac angioplasty or stenting\r\n* Myocardial infarction\r\n* Unstable angina\r\n* Coronary artery bypass graft surgery\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Patients who have experienced any of the following procedures or conditions currently or in the preceding months:\r\n* Coronary artery bypass graft\r\n* Angioplasty\r\n* Vascular stent\r\n* Myocardial infarction\r\n* Angina pectoris\r\n* Congestive heart failure New York Heart Association grade >= (ventricular arrhythmias requiring continuous therapy)\r\n* Supraventricular arrhythmias including atrial fibrillation, which are uncontrolled\r\n* Hemorrhagic or thrombotic stroke, including transient ischemic attacks or any other central nervous system bleeding\r\n* History of drug abuse or alcohol abuse, as judged by the investigator