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

Last updated: August 23, 2011
Sponsor: Sigma-Tau Research, Inc.
Overall Status: Completed

Phase

3

Condition

Intermittent Claudication

Claudication

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00399919
ST 04-302
  • Ages 40-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 thetreadmill test or prevent the subject from reaching their claudication-limited PWT

  • Current participation in an exercise training program or previous participtation in amonitored exercise training program within 6 months of the screening visit.

Study Design

Total Participants: 69
Study Start date:
April 01, 2006
Estimated Completion Date:
March 31, 2008

Study 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.

Connect with a study center

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Baptist Clinical Research

    Pensacola, Florida 32501
    United States

    Site Not Available

  • Western Suburban Cardiologists, Ltd.

    LaGrange, Illinois 60525
    United States

    Site Not Available

  • SIU School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • University of Massachusetts Medical Center

    Worchester, Massachusetts 01655
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14618
    United States

    Site Not Available

  • Asheville Cardiology Associates

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Durham VA Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

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