Status:
COMPLETED
Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
Lead Sponsor:
Sigma-Tau Research, Inc.
Collaborating Sponsors:
Colorado Prevention Center
Conditions:
Peripheral Vascular Diseases
Intermittent Claudication
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Ambulatory outpatient who are able to exercise
- Intermittent claudication due to peripheral artery disease
- Willingness to participate in a monitored exercise training program
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00399919
Start Date
April 1 2006
End Date
March 1 2008
Last Update
August 25 2011
Active Locations (9)
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1
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
2
Baptist Clinical Research
Pensacola, Florida, United States, 32501
3
Western Suburban Cardiologists, Ltd.
LaGrange, Illinois, United States, 60525
4
SIU School of Medicine
Springfield, Illinois, United States, 62702