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
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
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- 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