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

Sigma-Tau Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Peripheral Vascular Diseases

Intermittent Claudication

Treatments

Drug: PLC

Drug: Propionyl-L-Carnitine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00399919

ST 04-302

Details and patient eligibility

About

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.

Full description

To test the hypothesis that Propionyl-L-Carnitine taken in combination with monitored exercise training may improve exercise performance the study will randomize male or female adults with peripheral artery disease and claudication to receive either Proprionyl-L-Carnitine or Placebo.

Enrollment

69 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.