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COMPLETEDPhase 3NCT00399919

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...

Lead sponsor: Sigma-Tau Research, Inc.•9 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sigma-Tau Research, Inc.

Collaborators

Colorado Prevention Center

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.

Age

40 - 80 years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 25, 2011Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment69

Start dateApr 2006

Last updatedAug 25, 2011

Condition

Peripheral Vascular Diseases Intermittent Claudication

Locations shown

Jacksonville Center for Clinical Research

Jacksonville, Florida

Baptist Clinical Research

Pensacola, Florida

Western Suburban Cardiologists, Ltd.

LaGrange, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2011Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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