Status:
COMPLETED
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
Lead Sponsor:
Lee's Pharmaceutical Limited
Collaborating Sponsors:
Nanjing Medical University
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00809497
Start Date
May 1 2008
End Date
January 1 2011
Last Update
March 29 2012
Active Locations (1)
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1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053