Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00399919
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : August 25, 2011
Colorado Prevention Center
Information provided by (Responsible Party):
Sigma-Tau Research, Inc.

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
Peripheral Vascular Diseases Intermittent Claudication Drug: Propionyl-L-Carnitine Drug: PLC 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
Study Start Date : April 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Peak walking time [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Claudication onset time, activity level and quality of life [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00399919

Layout table for location information
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Baptist Clinical Research
Pensacola, Florida, United States, 32501
United States, Illinois
Western Suburban Cardiologists, Ltd.
LaGrange, Illinois, United States, 60525
SIU School of Medicine
Springfield, Illinois, United States, 62702
United States, Massachusetts
University of Massachusetts Medical Center
Worchester, Massachusetts, United States, 01655
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14618
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Sigma-Tau Research, Inc.
Colorado Prevention Center
Layout table for investigator information
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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sigma-Tau Research, Inc. Identifier: NCT00399919    
Other Study ID Numbers: ST 04-302
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: June 2009
Keywords provided by Sigma-Tau Research, Inc.:
Perhipheral Artery Disease
Intermittent Claudication due to Peripheral Artery Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Intermittent Claudication
Arterial Occlusive Diseases
Cardiovascular Diseases