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

This study has been completed.
Sponsor:
Collaborator:
Colorado Prevention Center
Information provided by (Responsible Party):
Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier:
NCT00399919
First received: November 14, 2006
Last updated: August 23, 2011
Last verified: June 2009
  Purpose

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 Intervention Phase
Peripheral Vascular Diseases
Intermittent Claudication
Drug: Propionyl-L-Carnitine
Drug: PLC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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).

Resource links provided by NLM:


Further study details as provided by Sigma-Tau Research, Inc.:

Primary Outcome Measures:
  • Peak walking time [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Claudication onset time, activity level and quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
NA
Drug: Propionyl-L-Carnitine
2 grams per day for six months
Drug: PLC
2 grams/day for six months

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399919

Locations
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
Investigators
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
  More Information

No publications provided by Sigma-Tau Research, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sigma-Tau Research, Inc.
ClinicalTrials.gov Identifier: NCT00399919     History of Changes
Other Study ID Numbers: ST 04-302
Study First Received: November 14, 2006
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sigma-Tau Research, Inc.:
Perhipheral Artery Disease
Claudication
Exercise
Intermittent Claudication due to Peripheral Artery Disease

Additional relevant MeSH terms:
Intermittent Claudication
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014