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

• Sponsor: Sigma-Tau Research, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00399919
• Collaborator: Colorado Prevention Center (Other)
• Enrollment: 69
• Locations: 9
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Diseases; Intermittent Claudication	Drug: Propionyl-L-Carnitine; Drug: PLC	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PLC Investigational drug	Drug: Propionyl-L-Carnitine; 2 grams per day for six months; Drug: PLC; 2 grams/day for six months
Placebo Comparator: Placebo	Drug: Propionyl-L-Carnitine; 2 grams per day for six months; Drug: PLC; 2 grams/day for six months

Outcome Measures

Primary Outcome Measures

1. Peak walking time [6 months]

Secondary Outcome Measures

1. Claudication onset time, activity level and quality of life [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University of Massachusetts Medical Center	Worchester	Massachusetts	United States	01655
6	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
7	University of Rochester Medical Center	Rochester	New York	United States	14618
8	Asheville Cardiology Associates	Asheville	North Carolina	United States	28803
9	Durham VA Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Sigma-Tau Research, Inc.
• Colorado Prevention Center

Investigators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sigma-Tau Research, Inc.
• ClinicalTrials.gov Identifier: NCT00399919
• Other Study ID Numbers: ST 04-302
• First Posted: Nov 15, 2006
• Last Update Posted: Aug 25, 2011
• Last Verified: Jun 1, 2009

• Keywords provided by Sigma-Tau Research, Inc.: Perhipheral Artery Disease; Claudication; Exercise; Intermittent Claudication due to Peripheral Artery Disease
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Intermittent Claudication

Study Results

No Results Posted as of Aug 25, 2011