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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399919

Enrollment

Registered

2006-11-15

Start date

2006-04-30

Completion date

2008-03-31

Last updated

2011-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication, Peripheral Vascular Diseases

Keywords

Perhipheral Artery Disease, Claudication, Exercise, Intermittent Claudication due to Peripheral Artery Disease

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.

Interventions

DRUGPropionyl-L-Carnitine

2 grams per day for six months

DRUGPLC

2 grams/day for six months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Peak walking time	6 months

Secondary

Measure	Time frame
Claudication onset time, activity level and quality of life	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026