Peripheral Arterial DiseasePhase 3PLCNCT00809497
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
A Phase 3 study testing Propionyl-L-carnitine Tablets in people with Peripheral Arterial Disease, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Propionyl-L-carnitine Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 239 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Jan 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The variability between the two standardized claudication tests during the wash-out period must be <20%, as assessed by the formular: (Highest MWD-Lowest MWD)/(Lowest MWDxx100%)
- At the last visit during the wash-out period, the ABI at rest must be ,0.9
Who cannot join
- with rest pain, ulceration, and/or gangrene
- PAD of a non-atherosclerotic nature
- Aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 6 months; any above ankle level amputation. Any type of major surgery during the last three months.
- Except PAD, any concomitant disease that can limit patients' performance in the treadmill exercise.
- with angina (at rest or activity) or any symptom which is sufficiently severe to discontinue the treadmill exercises.
- Myocardial infarction within 6 months
Show all 16Show fewer
- Severe cerebral dysfunction
- Type I diabetes (Stable type II diabetes can also be included)
- alcohol or drug abused history within 3 months
- Medium or severe anaemia (Hb,90g/L)
- Platelets <100 x 10 9/L
- Bleeding diathesis
- Renal insufficiency or hepatic function laboratory test result>1.5 normal value
- Treatment with LC or carnitien derivatives in the past 3 months
- Pregnancy, lactation, fertility without adequate protest against pregnancy
- Reject to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: A Randomized, Multi-centre, Double-blind and Placebo Controlled Clinical Study of the Propionyl-L-carnitine Hydrochloride Tablets
The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months continuous administration.
Read the detailed description
This is a randomized, multi-centre, double-blind and placebo controlled clinical study. Propionyl-L-Carnitine (PLC) is a kind of natural derivative of L-Carnitine (LC) and is produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an enzyme-mediated reaction involving propionyl-CoA and LC. For oral adminsitration, PLC shows that the decrease of the leg muscle carnitine of the PAD patient appears to correlate with poor exercise performance. It has recently been shown that the severity of the impairment in walking distance is correlated with the impairment in carntine metabolism at the muscle level. 2g daily of PLC supplementation can significantly improve the walking ability in patients with IC with a maximum walking capacity between 50 and 250 meters on the treadmill.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Propionyl-L-carnitine Tablets
- Keywords
- PLC for treatment of peripheral arterial diseases
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionyl-L-carnitine TabletsDrug
Also called DROMOS, ST261
500mg tablets, oral administration of 2g daily
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the difference between pre-and post-the treatment of each group
Measured: 4 months
Secondary outcomes (1)
Statistically describe the variance of ABI, CT and other indexes at the end of 4th month
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- Jianxin Li, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809497
- Sponsor's protocol ID
- PLC-LZ00108
- Other IDs
- SFDA-2006L03870
- Acronym
- PLC
- Status last verified
- Mar 2008
- First submitted
- 16 Dec 2008
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-centre, Double-blind and Placebo Controlled Clinical Study of the Propionyl-L-carnitine Hydrochloride Tablets
- ClinicalTrials.gov ID
- NCT00809497
- Acronym / sponsor ID
- PLC / PLC-LZ00108
- Conditions
- Peripheral Arterial Disease
- Keywords
- PLC for treatment of peripheral arterial diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Nanjing Medical University
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Dec 2008 (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.
The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months continuous administration.
Detailed description
This is a randomized, multi-centre, double-blind and placebo controlled clinical study. Propionyl-L-Carnitine (PLC) is a kind of natural derivative of L-Carnitine (LC) and is produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an enzyme-mediated reaction involving propionyl-CoA and LC. For oral adminsitration, PLC shows that the decrease of the leg muscle carnitine of the PAD patient appears to correlate with poor exercise performance. It has recently been shown that the severity of the impairment in walking distance is correlated with the impairment in carntine metabolism at the muscle level. 2g daily of PLC supplementation can significantly improve the walking ability in patients with IC with a maximum walking capacity between 50 and 250 meters on the treadmill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The variability between the two standardized claudication tests during the wash-out period must be <20%, as assessed by the formular: (Highest MWD-Lowest MWD)/(Lowest MWDxx100%)
- At the last visit during the wash-out period, the ABI at rest must be ,0.9
Key exclusion criteria (16 listed)
- with rest pain, ulceration, and/or gangrene
- PAD of a non-atherosclerotic nature
- Aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 6 months; any above ankle level amputation. Any type of major surgery during the last three months.
- Except PAD, any concomitant disease that can limit patients' performance in the treadmill exercise.
- with angina (at rest or activity) or any symptom which is sufficiently severe to discontinue the treadmill exercises.
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-carnitine TabletsAlso: DROMOS, ST261500mg tablets, oral administration of 2g daily | Drug | – |
Primary outcome
To compare the difference between pre-and post-the treatment of each group
Time frame: 4 months
1 secondary outcome
Statistically describe the variance of ABI, CT and other indexes at the end of 4th month
Time frame: 4 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 29 Mar 2012.
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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.
Jianxin Li, MD principal investigator
Xuanwu Hospital, Beijing
1 site 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 Tablets in people with Peripheral Arterial Disease, run by Lee's Pharmaceutical Limited at 1 site in China.
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 2 inclusion and 16 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 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
To compare the difference between pre-and post-the treatment of each group (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2012; AzTrials last refreshed its copy on 26 Oct 2026.