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

Sigma-Tau Research, Inc. (Industry)
Overall Status
Completed ID
Colorado Prevention Center (Other)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Actual Enrollment :
69 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: PLC

Investigational drug

Drug: Propionyl-L-Carnitine
2 grams per day for six months

Drug: PLC
2 grams/day for six months

Placebo Comparator: Placebo

Drug: Propionyl-L-Carnitine
2 grams per day for six months

Drug: PLC
2 grams/day for six months

Outcome Measures

Primary Outcome Measures

  1. Peak walking time [6 months]

Secondary Outcome Measures

  1. Claudication onset time, activity level and quality of life [6 months]

Eligibility Criteria


Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
Accepts 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.

Contacts and Locations


Site City State Country Postal Code
1 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
2 Baptist Clinical Research Pensacola Florida United States 32501
3 Western Suburban Cardiologists, Ltd. LaGrange Illinois United States 60525
4 SIU School of Medicine Springfield Illinois United States 62702
5 University of Massachusetts Medical Center Worchester Massachusetts United States 01655
6 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
7 University of Rochester Medical Center Rochester New York United States 14618
8 Asheville Cardiology Associates Asheville North Carolina United States 28803
9 Durham VA Medical Center Durham North Carolina United States 27705

Sponsors and Collaborators

  • Sigma-Tau Research, Inc.
  • Colorado Prevention Center


  • Principal Investigator: Edgar Carell, Western Suburban Cardiologists, Ltd.
  • Principal Investigator: Kenneth Morris, Durham VA Medical Center
  • Principal Investigator: Bruce Cutler, University of Massachusetts, Worcester
  • Principal Investigator: Robert McLafferty, SIU School of Medicine
  • Principal Investigator: Richard Powell, Dartmouth-Hitchcock Medical Center
  • Principal Investigator: Layne Yonehiro, Baptist Clinical Research
  • Principal Investigator: Karl Illig, University of Rochester
  • Principal Investigator: William Abernethy, Asheville Cardiology Associates
  • Principal Investigator: Michael Koren, Jacksonville Center For Clinical Research

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Sigma-Tau Research, Inc. Identifier:
Other Study ID Numbers:
  • ST 04-302
First Posted:
Nov 15, 2006
Last Update Posted:
Aug 25, 2011
Last Verified:
Jun 1, 2009

Study Results

No Results Posted as of Aug 25, 2011