Evaluation of Cilostazol in Combination With L-Carnitine

Inclusion Criteria

• The subject is >40 years old.
• The subject has a diagnosis of Intermittent Claudication (IC) due to Peripheral Artery Disease (PAD).
• Ankle brachial index (ABI) 10).
• The subject has had a transient ischemic attack (TIA) or deep vein thrombosis in the last 3 months.
• The subject has had a stroke within the last 6 months.
• The subject has participated in an angiogenic gene therapy study, unless known to be given placebo.
• The subject has any of the following laboratory parameters at Screening 1:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin >3 times the upper limit of normal (ULN)
• Serum creatinine >2.5 mg/dL
• Hemoglobin (Hb) 15 x 103/µL
• Platelet count 180/100 mmHg) or uncontrolled arrhythmic disorders at Screening 1.
• History of coronary or peripheral revascularization within 6 months prior to Screening 1.
• The subject plans to undergo coronary or peripheral revascularization during the course of the study.
• The subject is currently taking L-carnitine or medication for claudication (including pentoxifylline or cilostazol). In this situation, the subject would become eligible for Screening 1 after a 6 week washout of the medication.
• Subjects currently taking or those who anticipate taking ketoconazole, itraconazole, or erythromycin. The subject would become eligible for Screening 1 immediately after completion of therapy or discontinuation of the drug(s).
• The subject has a known, active malignancy that requires active anti-neoplastic therapy. (stable basal cell skin cancer allowed. Cancer being treated soley with hormonal therapy is allowed.)
• The subject has a severe co-morbidity with an expected survival of less than 2 years.
• The subject's Peak Walking Time (PWT) is limited by symptoms other than claudication (e.g., shortness of breath (SOB), fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their Peak Walking Time (PWT) from study therapy to the extent that his or her walking would then be limited by a symptom other than claudication, the subject should not be enrolled.
• The subject has a history of alcohol or other substance abuse within 6 months of Screening 1.
• The subject has an inability to tolerate oral medication administration.
• The subject has a known or suspected allergy to the study medication(s) or class of study medication(s) (cilostazol or L-carnitine) to be administered.
• The subject has initiated an exercise training program within 3 months of Screening 1, has the inability to maintain his or her current level of physical activity throughout the study, or the subject plans on enrolling in an exercise training program during the study.
• The subject plans to change his/her smoking status during the planned duration of this study (subjects will be advised that stopping smoking is best for his/her health).
• The subject is currently pregnant or breastfeeding.
• The subject has received an investigational drug or biological agent within 30 days prior to Screening 1.
• The subject is currently participating in or plans to enroll in another clinical trial during this study.
• The subject has any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial.
• In the Investigator's opinion, the subject experienced any Adverse Events (AEs) during the tolerance phase of the Screening period that present a potential ongoing safety concern.