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A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases (PLC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809497
First Posted: December 17, 2008
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nanjing Medical University
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
  Purpose
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.

Condition Intervention Phase
Peripheral Arterial Disease Drug: Propionyl-L-carnitine Tablets Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-centre, Double-blind and Placebo Controlled Clinical Study of the Propionyl-L-carnitine Hydrochloride Tablets

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • To compare the difference between pre-and post-the treatment of each group [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Statistically describe the variance of ABI, CT and other indexes at the end of 4th month [ Time Frame: 4 months ]

Enrollment: 239
Study Start Date: May 2008
Study Completion Date: January 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Propionyl-L-carnitine Tablets
    500mg tablets, oral administration of 2g daily
    Other Name: DROMOS, ST261
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809497


Locations
China, Beijing
Xuanwu Hospital Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Nanjing Medical University
Investigators
Principal Investigator: Jianxin Li, MD Xuanwu Hospital, Beijing
  More Information

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT00809497     History of Changes
Other Study ID Numbers: PLC-LZ00108
SFDA-2006L03870
First Submitted: December 16, 2008
First Posted: December 17, 2008
Last Update Posted: March 29, 2012
Last Verified: March 2008

Keywords provided by Lee's Pharmaceutical Limited:
PLC for treatment of peripheral arterial diseases

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases