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

Intermittent Claudication Clinical Trial

Official title:

Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399919
• Other study ID #: ST 04-302
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2006
• Last updated: August 23, 2011
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: June 2009
• Source: Sigma-Tau Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Propionyl-L-Carnitine
2 grams per day for six months
• PLC
2 grams/day for six months

Locations

Country	Name	City	State
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Western Suburban Cardiologists, Ltd.	LaGrange	Illinois
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Baptist Clinical Research	Pensacola	Florida
United States	University of Rochester Medical Center	Rochester	New York
United States	SIU School of Medicine	Springfield	Illinois
United States	University of Massachusetts Medical Center	Worchester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Sigma-Tau Research, Inc.	Colorado Prevention Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak walking time		6 months	Yes
Secondary	Claudication onset time, activity level and quality of life		6 months	Yes