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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Collaborator: Nanjing Medical University

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