Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
NCT ID: NCT00399919
Last Updated: 2011-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
2006-04-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PLC
Investigational drug
Propionyl-L-Carnitine
2 grams per day for six months
PLC
2 grams/day for six months
Placebo
Propionyl-L-Carnitine
2 grams per day for six months
PLC
2 grams/day for six months
Interventions
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Propionyl-L-Carnitine
2 grams per day for six months
PLC
2 grams/day for six months
Eligibility Criteria
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Inclusion Criteria
* Intermittent claudication due to peripheral artery disease
* Willingness to participate in a monitored exercise training program
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Colorado Prevention Center
OTHER
Sigma-Tau Research, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edgar Carell
Role: PRINCIPAL_INVESTIGATOR
Western Suburban Cardiologists, Ltd.
Kenneth Morris
Role: PRINCIPAL_INVESTIGATOR
Durham VA Medical Center
Bruce Cutler
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Robert McLafferty
Role: PRINCIPAL_INVESTIGATOR
SIU School of Medicine
Richard Powell
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Layne Yonehiro
Role: PRINCIPAL_INVESTIGATOR
Baptist Clinical Research
Karl Illig
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
William Abernethy
Role: PRINCIPAL_INVESTIGATOR
Asheville Cardiology Associates
Michael Koren
Role: PRINCIPAL_INVESTIGATOR
Jacksonville Center For Clinical Research
Locations
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Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Baptist Clinical Research
Pensacola, Florida, United States
Western Suburban Cardiologists, Ltd.
LaGrange, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
University of Massachusetts Medical Center
Worchester, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of Rochester Medical Center
Rochester, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
Durham VA Medical Center
Durham, North Carolina, United States
Countries
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References
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Mays RJ, Wesselman CW, White R, Creager MA, Amato A, Greenwalt M, Hiatt WR. Automated Detection of Exercise Sessions in Patients With Peripheral Artery Disease: EVIDENCE FOR AN EXERCISE DOSE RESPONSE TO TRAINING. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):176-181. doi: 10.1097/HCR.0000000000000553.
Hiatt WR, Creager MA, Amato A, Brass EP. Effect of propionyl-L-carnitine on a background of monitored exercise in patients with claudication secondary to peripheral artery disease. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):125-32. doi: 10.1097/HCR.0b013e3181f1fd65.
Other Identifiers
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ST 04-302
Identifier Type: -
Identifier Source: org_study_id
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