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

S

Sigma-Tau Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Peripheral Vascular Diseases
Intermittent Claudication

Treatments

Drug: PLC
Drug: Propionyl-L-Carnitine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00399919
ST 04-302

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

69 participants in 2 patient groups, including a placebo group

PLC
Experimental group
Description:
Investigational drug
Treatment:
Drug: PLC
Drug: Propionyl-L-Carnitine
Placebo
Placebo Comparator group
Treatment:
Drug: PLC
Drug: Propionyl-L-Carnitine

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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