Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)

Completed · Phase 3 · Has a placebo group

Conditions studied: Peripheral Vascular Diseases, Intermittent Claudication

In brief

Patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. Carnitine allows muscles to function properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in combination with a monitored exercise training program.

Key facts

Study ID

NCT00399919

Run by

Sigma-Tau Research, Inc.

People needed

69

Starts

2006-04-01

Expected to finish

2008-03-01

Last updated by the study team

2011-08-25

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ambulatory outpatient who are able to exercise
• Intermittent claudication due to peripheral artery disease
• Willingness to participate in a monitored exercise training program

You may not qualify if…

• Pain at rest, ischemic ulcerations, gangrene of the lower extremity
• Peripheral Artery Disease of a non-atherosclerotic nature
• Any disease process other than PAD, that may interfere with performance during the treadmill test or prevent the subject from reaching their claudication-limited PWT
• Current participation in an exercise training program or previous participtation in a monitored exercise training program within 6 months of the screening visit.

Where it is running

• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Baptist Clinical Research — Pensacola, Florida, United States
• Western Suburban Cardiologists, Ltd. — LaGrange, Illinois, United States
• SIU School of Medicine — Springfield, Illinois, United States
• University of Massachusetts Medical Center — Worchester, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Asheville Cardiology Associates — Asheville, North Carolina, United States
• Durham VA Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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