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

NCT00399919 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2011-08-25

No results posted yet for this study

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.

Conditions

  • Peripheral Vascular Diseases
  • Intermittent Claudication

Interventions

DRUG

Propionyl-L-Carnitine

2 grams per day for six months

DRUG

PLC

2 grams/day for six months

Sponsors & Collaborators

  • Colorado Prevention Center

    collaborator OTHER

  • Sigma-Tau Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Edgar Carell · Western Suburban Cardiologists, Ltd.

  • Kenneth Morris · Durham VA Medical Center

  • Bruce Cutler · University of Massachusetts, Worcester

  • Robert McLafferty · SIU School of Medicine

  • Richard Powell · Dartmouth-Hitchcock Medical Center

  • Layne Yonehiro · Baptist Clinical Research

  • Karl Illig · University of Rochester

  • William Abernethy · Asheville Cardiology Associates

  • Michael Koren · Jacksonville Center For Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399919 on ClinicalTrials.gov