A Clinical Study on Efficacy & Safety Profile of Propionyl-L-Carnitine Tablets for Peripheral Arterial Diseases - Full Text View

Sponsors and Collaborators:	Lee's Pharmaceutical Limited Nanjing Medical University
Information provided by:	Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:	NCT00809497

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 III

Drug Information available for: Carnitine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multi-Centre, Double-Blind and Placebo Controlled Clinical Study of the Propionyl-L-Carnitine Hydrochloride Tablets

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 ]

Estimated Enrollment:	240
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

500mg tablets, oral administration of 2g daily

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

Contacts

Contact: Benjamin Li, PhD	(852) 2314-1282	drli@leespharm.com
Contact: Vivian Fung	(852) 2314-1282	vivian@leespharm.com

Locations

China
Xuanwu Hospital Capital Medical University	Recruiting
Beijing, China, 100053
Contact: Xiao Yi Li, PhD (852) 2314-1282 drli@leespharm.com
Principal Investigator: Jianxi Li, MD

Sponsors and Collaborators

Lee's Pharmaceutical Limited

Nanjing Medical University

Investigators

Principal Investigator:

Jianxin Li, MD

Xuanwu Hospital Capital Medical University

More Information

Responsible Party:	Xuanwu Hospital Capital Medical University ( Vivian Fung )
Study ID Numbers:	PLC-LZ00108, SFDA-2006L03870
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809497
Health Authority:	China: State Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:

PLC for treatment of peripheral arterial diseases

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
Carnitine

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins
Physiological Effects of Drugs

Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009