Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Lee’s Pharmaceutical has achieved the targeted patient enrollment for its clinical trial conducted in China on Sigma-Tau’s original product, Dromos (Propionyl-L-Carnitine hydrochloride tablets, PLC), evaluating the effectiveness and safety for treatment of peripheral arterial diseases (intermittent claudication) in Chinese patients.
Subscribe to our email newsletter
Propionyl-L-carnitine is a short-chain fatty ester of carnitine and a naturally occurring substance required in mammalian energy metabolism.
With the completion of enrollment, Lee’s Pharmaceutical expects to have the study report ready by end of 2010 and to submit the application for marketing authorization early next year.
Lee’s Pharma said that the trial has completed its targeted enrollment with total of 239 patients and completion of follow-up is expected in 4 months.
The multi-centers, randomised, double-blind and placebo controlled clinical trial was conducted over 9 clinical centers located in Beijing, Shanghai, Tianjin, Nanjing and Wuhan etc and led by Xuanwu Hospital of Capital Medical University.
Benjamin Li, CEO of Lee’s Pharma, said: “We are pleased to have reached this important milestone in the PLC study. We would like to thank the dedicated clinical investigators, study coordinators, patients and our clinical development team who participated in our trial as well as the support from Sigma-Tau Group.
“We are very excited about the progress of this study, and we look forward to the successful registration of PLC in China.”