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

August 23, 2011 updated by: Sigma-Tau Research, Inc.

Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Pensacola, Florida, United States, 32501
        • Baptist Clinical Research
    • Illinois
      • LaGrange, Illinois, United States, 60525
        • Western Suburban Cardiologists, Ltd.
      • Springfield, Illinois, United States, 62702
        • SIU School of Medicine
    • Massachusetts
      • Worchester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Rochester, New York, United States, 14618
        • University of Rochester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Propionyl-L-Carnitine
2 grams per day for six months
Drug: PLC
2 grams/day for six months
EXPERIMENTAL: PLC
Investigational drug
Drug: Propionyl-L-Carnitine
2 grams per day for six months
Drug: PLC
2 grams/day for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak walking time
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Claudication onset time, activity level and quality of life
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sigma-Tau Research, Inc.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (ESTIMATE)

November 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2011

Last Update Submitted That Met QC Criteria

August 23, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST 04-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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