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

Primary Purpose

Peripheral Vascular Diseases, Intermittent Claudication

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Propionyl-L-Carnitine
PLC
Sponsored by
Sigma-Tau Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Perhipheral Artery Disease, Claudication, Exercise, Intermittent Claudication due to Peripheral Artery Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jacksonville Center for Clinical Research
  • Baptist Clinical Research
  • Western Suburban Cardiologists, Ltd.
  • SIU School of Medicine
  • University of Massachusetts Medical Center
  • Dartmouth-Hitchcock Medical Center
  • University of Rochester Medical Center
  • Asheville Cardiology Associates
  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PLC

Placebo

Arm Description

Investigational drug

Outcomes

Primary Outcome Measures

Peak walking time

Secondary Outcome Measures

Claudication onset time, activity level and quality of life

Full Information

First Posted
November 14, 2006
Last Updated
August 23, 2011
Sponsor
Sigma-Tau Research, Inc.
Collaborators
Colorado Prevention Center
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1. Study Identification

Unique Protocol Identification Number
NCT00399919
Brief Title
Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
Official Title
Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sigma-Tau Research, Inc.
Collaborators
Colorado Prevention Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases, Intermittent Claudication
Keywords
Perhipheral Artery Disease, Claudication, Exercise, Intermittent Claudication due to Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLC
Arm Type
Experimental
Arm Description
Investigational drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propionyl-L-Carnitine
Intervention Description
2 grams per day for six months
Intervention Type
Drug
Intervention Name(s)
PLC
Intervention Description
2 grams/day for six months
Primary Outcome Measure Information:
Title
Peak walking time
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Claudication onset time, activity level and quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Carell
Organizational Affiliation
Western Suburban Cardiologists, Ltd.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Morris
Organizational Affiliation
Durham VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Cutler
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert McLafferty
Organizational Affiliation
SIU School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Powell
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Layne Yonehiro
Organizational Affiliation
Baptist Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Illig
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Abernethy
Organizational Affiliation
Asheville Cardiology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Koren
Organizational Affiliation
Jacksonville Center For Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Baptist Clinical Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Western Suburban Cardiologists, Ltd.
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worchester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33186199
Citation
Mays RJ, Wesselman CW, White R, Creager MA, Amato A, Greenwalt M, Hiatt WR. Automated Detection of Exercise Sessions in Patients With Peripheral Artery Disease: EVIDENCE FOR AN EXERCISE DOSE RESPONSE TO TRAINING. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):176-181. doi: 10.1097/HCR.0000000000000553.
Results Reference
derived
PubMed Identifier
20861750
Citation
Hiatt WR, Creager MA, Amato A, Brass EP. Effect of propionyl-L-carnitine on a background of monitored exercise in patients with claudication secondary to peripheral artery disease. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):125-32. doi: 10.1097/HCR.0b013e3181f1fd65.
Results Reference
derived

Learn more about this trial

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

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