Evaluation of Cilostazol in Combination With L-Carnitine

PAD is a narrowing of the blood vessels that supply the leg with blood. It is caused by
atherosclerosis (hardening of the arteries).

Muscles require oxygen carried by the blood. When the leg muscles do not get enough blood
and oxygen, this can cause pain, cramping, fatigue, and/or discomfort in the leg muscles
during walking or exercise. These symptoms are called intermittent claudication (IC). In
more severe cases, tissues do not get enough blood and oxygen at rest, and pain may also be
present when the legs are resting. PAD is one of the most common causes of pain and
disability in people between 55 and 75 years of age.

Cilostazol is a medication currently available by prescription for intermittent
claudication. L-carnitine is an over-the-counter supplement. It is a natural substance in
the human body and is also in some red meats, nuts, and energy drinks.

Some subjects in the study will take L-carnitine with cilostazol and others will take
placebo with cilostazol. The purpose of this study is to see how safe and effective L
carnitine taken with cilostazol is compared to placebo taken with cilostazol for people with
intermittent claudication. A placebo is a tablet or pill that looks like regular
medication, but it doesn't have any actual medicine in it. A second purpose of the study is
to see if L-carnitine is absorbed into the blood stream.