Peripheral Vascular DiseasesPhase 3NCT00399919
Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
A Phase 3 study testing Propionyl-L-Carnitine and PLC in people with Peripheral Vascular Diseases and Intermittent Claudication, run by Sigma-Tau Research, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Vascular Diseases, Intermittent Claudication
- What is being tested?
- Propionyl-L-Carnitine and PLC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory outpatient who are able to exercise
- Intermittent claudication due to peripheral artery disease
- Willingness to participate in a monitored exercise training program
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Durham VA Medical Center
Durham, North Carolina, 27705
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Western Suburban Cardiologists, Ltd.
LaGrange, Illinois, 60525
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Baptist Clinical Research
Pensacola, Florida, 32501
University of Rochester Medical Center
Rochester, New York, 14618
SIU School of Medicine
Springfield, Illinois, 62702
University of Massachusetts Medical Center
Worchester, Massachusetts, 01655
About this study
Official title: Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
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.
Read the 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.
- Being tested
- Propionyl-L-Carnitine, PLC
- Keywords
- Perhipheral Artery Disease, Claudication, Exercise, Intermittent Claudication due to Peripheral Artery Disease
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionyl-L-CarnitineDrug
2 grams per day for six months
PLCDrug
2 grams/day for six months
| Study group | Role | What they receive |
|---|---|---|
| PLC | Experimental | Investigational drug Receives: Drug: Propionyl-L-Carnitine; Drug: PLC |
| Placebo | Placebo comparator | Not described Receives: Drug: Propionyl-L-Carnitine; Drug: PLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak walking time
Measured: 6 months
Secondary outcomes (1)
Claudication onset time, activity level and quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigma-Tau Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Colorado Prevention Center
- Responsible party
- Sponsor
- Investigators
- Edgar Carell, Principal investigator, Western Suburban Cardiologists, Ltd.Kenneth Morris, Principal investigator, Durham VA Medical CenterBruce Cutler, Principal investigator, University of Massachusetts, WorcesterRobert McLafferty, Principal investigator, SIU School of MedicineRichard Powell, Principal investigator, Dartmouth-Hitchcock Medical CenterLayne Yonehiro, Principal investigator, Baptist Clinical ResearchKarl Illig, Principal investigator, University of RochesterWilliam Abernethy, Principal investigator, Asheville Cardiology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399919
- Sponsor's protocol ID
- ST 04-302
- Status last verified
- Jun 2009
- First submitted
- 14 Nov 2006
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33186199Hiatt 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.
PubMed 20861750
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
- ClinicalTrials.gov ID
- NCT00399919
- Acronym / sponsor ID
- ST 04-302
- Keywords
- Perhipheral Artery Disease, Claudication, Exercise, Intermittent Claudication due to Peripheral Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sigma-Tau Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Colorado Prevention Center
- Study start
- Apr 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLC | Experimental | Drug: Propionyl-L-Carnitine, Drug: PLCInvestigational drug |
| Placebo | Placebo comparator | Drug: Propionyl-L-Carnitine, Drug: PLC |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory outpatient who are able to exercise
- Intermittent claudication due to peripheral artery disease
- Willingness to participate in a monitored exercise training program
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propionyl-L-Carnitine2 grams per day for six months | Drug | PLC, Placebo |
| PLC2 grams/day for six months | Drug | PLC, Placebo |
Primary outcome
Peak walking time
Time frame: 6 months
1 secondary outcome
Claudication onset time, activity level and quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
- Derived from this study: PubMed 33186199Mays 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.
- Derived from this study: PubMed 20861750Hiatt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Carell principal investigator
Western Suburban Cardiologists, Ltd.
Kenneth Morris principal investigator
Durham VA Medical Center
Bruce Cutler principal investigator
University of Massachusetts, Worcester
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propionyl-L-Carnitine and PLC in people with Peripheral Vascular Diseases and Intermittent Claudication, run by Sigma-Tau Research, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak walking time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00399919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2011.