29/12/2016
Tasly T89 : the World First Compound Chinese Herbal Drug through FDA’s Phase-III Clinical Trials
The randomized global, multi-center, double-blind and large-sample phase-three clinical trials of T89, a proprietary being marketed by Tasly in China, which had been carried out for the certification by the before marketing in the United States, after a succession of jobs in respect of data management and statistical analysis, were recently concluded with a Top Line Analysis Report.
According to the outcomes of the trials, is safe and effective in the treatment of chronic stable angina pectoris, and, in comparison with the placebo group and the Sanqi and borneol decomposition group, when administered in high or low doses, produces significant clinical effects on patients with serious stable angina pectoris featuring various types of electrocardiographic abnormality. Compared with the placebo group, both high-dose and low-dose T89 groups reduced biweekly nitroglycerin consumption by 25%, and significantly reduced biweekly frequency of angina by 27%. The clinical value of T89 was once again proved in the trials.
During the trials, no serious adverse events were found in connection with T89, and other common adverse events, which occurred with low frequency, were mild and self-curable. The outcomes further justified the safety and effectiveness of T89 as indicated in Phase Two.
T89, as the world first compound Chinese herbal drug having passed the U.S. Food and Drug Administration-prescribed global multi-center phase-three clinical trials, involved considerable innovations, especially the origination of the dripping pill dosage form for new drug application, which showed a new way for studies on TCM globalization and opened the door for globalization.
