Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
1 other identifier
interventional
69
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2006
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedAugust 25, 2011
June 1, 2009
1.9 years
November 14, 2006
August 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak walking time
6 months
Secondary Outcomes (1)
Claudication onset time, activity level and quality of life
6 months
Study Arms (2)
PLC
EXPERIMENTALInvestigational drug
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Ambulatory outpatient who are able to exercise
- Intermittent claudication due to peripheral artery disease
- Willingness to participate in a monitored exercise training program
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sigma-Tau Research, Inc.lead
- Colorado Prevention Centercollaborator
Study Sites (9)
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Baptist Clinical Research
Pensacola, Florida, 32501, United States
Western Suburban Cardiologists, Ltd.
LaGrange, Illinois, 60525, United States
SIU School of Medicine
Springfield, Illinois, 62702, United States
University of Massachusetts Medical Center
Worchester, Massachusetts, 01655, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University of Rochester Medical Center
Rochester, New York, 14618, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28803, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Related Publications (2)
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.
PMID: 33186199DERIVEDHiatt 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.
PMID: 20861750DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 15, 2006
Study Start
April 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
August 25, 2011
Record last verified: 2009-06