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

Peripheral Arterial Disease Clinical Trial

— PLC  

Official title:

A Randomized, Multi-centre, Double-blind and Placebo Controlled Clinical Study of the Propionyl-L-carnitine Hydrochloride Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809497
• Other study ID #: PLC-LZ00108
• Secondary ID: SFDA-2006L03870
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: March 28, 2012
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: March 2008
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: January 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Propionyl-L-carnitine Tablets
500mg tablets, oral administration of 2g daily

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the difference between pre-and post-the treatment of each group		4 months	Yes
Secondary	Statistically describe the variance of ABI, CT and other indexes at the end of 4th month		4 months	Yes