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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:
Collaborator:
Nanjing Medical University
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT00809497
First received: December 16, 2008
Last updated: March 28, 2012
Last verified: March 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 capital medical university
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT00809497     History of Changes
Other Study ID Numbers: PLC-LZ00108, SFDA-2006L03870
Study First Received: December 16, 2008
Last Updated: March 28, 2012
Health Authority: China: Food and Drug Administration

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
 Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013