ARTICLE | Company News

Takeda cardiovascular news

March 17, 2014 7:00 AM UTC

Takeda appointed law firm Jones Day as a third-party investigator in response to issues raised by the media regarding the investigator initiated Phase III CASE-J trial of the pharma's hypertension drug Blopress candesartan cilexetil. The open-label, Japanese trial, which was conducted by Kyoto University, compared Blopress to amlodipine besilate in high-risk hypertensive patients from 2001 to 2006. Takeda used a graph in promotional literature indicating that Blopress was more effective than Norvasc amlodipine besilate from Pfizer Inc. (NYSE:PFE, New York, N.Y.), despite final data from the trial published in Hypertension concluding there was no difference between the two drugs. Takeda said the promotional materials that are under investigation are no longer being used.

According to an internal investigation by Takeda, promotional activities referred to data presented at the International Society for Hypertension meeting in Fukuoka in 2006, which "in some cases represented incomplete descriptions of clinical results." Takeda also said the internal investigation confirmed that the company was not involved in the statistical analysis of CASE-J and that no employees had access to the CASE-J database. Additionally, the company said it does not believe that grants made by the company to Kyoto University's EBM Center represent a conflict of interest. ...