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

Phase 3

Completed

• Conditions: Peripheral Vascular Diseases; Intermittent Claudication
• Interventions: Drug: Propionyl-L-Carnitine; Drug: PLC

• Registration Number: NCT00399919
• Lead Sponsor: Sigma-Tau Research, Inc.

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.

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 artery disease and claudication to receive either Proprionyl-L-Carnitine or Placebo.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-06
• Last Update Submitted: 2011-08-23
• Last Update Posted: 2011-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLC	PLC	Investigational drug
Placebo	PLC	-
Placebo	Propionyl-L-Carnitine	-
PLC	Propionyl-L-Carnitine	Investigational drug

Primary Outcome Measures

Name	Time	Method
Peak walking time	6 months

Secondary Outcome Measures

Name	Time	Method
Claudication onset time, activity level and quality of life	6 months

Trial Locations

Locations (9)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Western Suburban Cardiologists, Ltd.; 🇺🇸 LaGrange, Illinois, United States

Baptist Clinical Research; 🇺🇸 Pensacola, Florida, United States

SIU School of Medicine; 🇺🇸 Springfield, Illinois, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

University of Massachusetts Medical Center; 🇺🇸 Worchester, Massachusetts, United States

Asheville Cardiology Associates; 🇺🇸 Asheville, North Carolina, United States

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States