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Completed

NCT Number: NCT00399919

Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of 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.

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Key information

Conditions

Peripheral Vascular Diseases Behavior Cardiovascular Diseases Intermittent Claudication Motor Activity Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Signs and Symptoms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jacksonville Center for Clinical Research, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propionyl-L-Carnitine

Drug

2 grams per day for six months

PLC

Drug

2 grams/day for six months

Primary outcomes

  1. Peak walking time

    Time frame: 6 months

Secondary outcomes

  1. Claudication onset time, activity level and quality of life

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sigma-Tau Research, Inc.

Industry

Collaborators

  • Colorado Prevention Center

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 15, 2006
Registry last updated
Aug 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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