Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication

Exclusion Criteria

• •Pregnant or lactating
• •Current or history of critical limb ischemia (CLI)
• •Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder
• •Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions
• •A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN
• •Walking limited by reasons other than claudication
• •Conditions other than IC of significant severity that could confound PWT on the ETT
• •Concurrent severe congestive heart failure (CHF)
• •Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL)
• •Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL
• •Renal and/or carotid revascularization procedure within 3 mo. of ENRL
• •Transient ischemic attack (TIA) within 3 mo. before ENRL
• •Deep vein thrombosis (DVT) within 3 mo. before ENRL
• •Severe chronic obstructive pulmonary disease (COPD)
• •Thrombocytopenia
• •Undergoing hemodialysis or peritoneal dialysis
• •Pts. w/immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy
• •Neurological dementia
• •Stroke
• •Clinically significant electrocardiogram (ECG) change during or after ETT at SCRN or Baseline visit(s)
• •Cerebrovascular infarct within 3 mo. of SCRN
• •Poorly controlled type 1 or type 2 diabetes at SCRN
• •History of migraine headaches within last 12 mo.
• •Patients with clinically significant abnormal hematology labs or blood chemistry labs
• •Body mass index \> 35
• •Hypertension at SCRN defined as resting BP values of \> 170 mmHg systolic and/or \> 110 mmHg diastolic
• •Hypotension at SCRN defined as resting BP values \< 100 mmHg systolic or \< 55 mmHg diastolic or symptomatic hypotension
• •Previous treatment with any formulation of TSC
• •Known allergy or hypersensitivity to any excipient (gamma-cyclodextrin, mannitol, glycine) of TSC formulation
• •Previous treatment with gene therapy or other VEGF-related treatment within 12 mo. of SCRN
• •Patients with recent history of alcoholism or drug abuse, or severe emotional, behavioral, or psychiatric problems
• •Patients receiving experimental medications or participating in other study using an experimental drug or procedure within 45 days prior to ENRL