Peripheral Arterial Disease Clinical Trial
Official title:
Evaluation of Cilostazol in Combination With L-Carnitine in Subjects With Intermittent Claudication
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 second purpose of the study is to see if L-carnitine is absorbed into the blood stream.
Peripheral Artery Disease (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. Peripheral Artery Disease (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.
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