Safety and Efficacy of Propionyl-L-Carnitine in Peripheral Arterial Disease (Intermittent Claudication)

A Multi-Center, Dose-Ranging Study
Industry sponsored contract

This double-blind, placebo-controlled trial was designed to investigate the safety and efficacy of three different doses of propionyl-l-carnitine hydrochloride in patients with chronic occlusive arterial disease of the lower extremities. This project utilized centralized data entry at the CTDMC. The CTDMC was responsible for data management and analyses for this study. A Final Report containing efficacy and safety analyses, descriptions of the study and CTDMC procedures, and complete data listings and documentation suitable for submission to the FDA, was prepared by the CTDMC and forwarded to the sponsoring organization.