NCT00399919

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sigma-Tau Research, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Diseases
• Intermittent Claudication

Interventions

Type	Name	Description
DRUG	Propionyl-L-Carnitine	2 grams per day for six months
DRUG	PLC	2 grams/day for six months

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-11-15
• Last updated: 2011-08-25

Locations

9 sites across 1 country: United States