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

March 28, 2012 updated by: Lee's Pharmaceutical Limited

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

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.

Study Overview

Status

Completed

Conditions

Peripheral Arterial Disease

Intervention / Treatment

Drug: Propionyl-L-carnitine Tablets

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100053
    - Xuanwu Hospital Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the difference between pre-and post-the treatment of each group Time Frame: 4 months	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Statistically describe the variance of ABI, CT and other indexes at the end of 4th month Time Frame: 4 months	4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Collaborators

Nanjing Medical University

Investigators

Principal Investigator: Jianxin Li, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria