Back to resultsA Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases (PLC)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Propionyl-L-carnitine Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring PLC for treatment of peripheral arterial diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Xuanwu Hospital Capital Medical University
Outcomes
Primary Outcome Measures
To compare the difference between pre-and post-the treatment of each group
Secondary Outcome Measures
Statistically describe the variance of ABI, CT and other indexes at the end of 4th month
Full Information
NCT ID
NCT00809497
First Posted
December 16, 2008
Last Updated
March 28, 2012
Sponsor
Lee's Pharmaceutical Limited
Collaborators
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00809497
Brief Title
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
Acronym
PLC
Official Title
A Randomized, Multi-centre, Double-blind and Placebo Controlled Clinical Study of the Propionyl-L-carnitine Hydrochloride Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
Collaborators
Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
PLC for treatment of peripheral arterial diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Propionyl-L-carnitine Tablets
Other Intervention Name(s)
DROMOS, ST261
Intervention Description
500mg tablets, oral administration of 2g daily
Primary Outcome Measure Information:
Title
To compare the difference between pre-and post-the treatment of each group
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Statistically describe the variance of ABI, CT and other indexes at the end of 4th month
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxin Li, MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
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