Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399919
Status:
COMPLETED
Last Update Posted:
2011-08-25
First Post:
2006-11-14
Brief Title:
Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease Intermittent Claudication
Sponsor:
Sigma-Tau Research Inc
Organization:
Sigma-Tau Research Inc
Study Overview
Official Title:
Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease Intermittent Claudication
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None