BI and Genentech terminate TNKase/Metalyse trial

17 July 2005

German drugmaker Boehringer Ingelheim and US biotechnology major Genentech have terminated their randomized, open-label Phase IIIb/IV clinical study of the single-bolus thrombolytic TNKase/ Metalyse (tenecteplase) in combination with a planned percutaneous coronary intervention versus PCI alone in patients with acute myocardial infarctions, due to a difference in the 30-day mortality rate between two treatment groups. Enrollment in the trial was suspended in April following the recommendation of the Data Safety Monitoring Board during a planned interim analysis. It was found that the mortality rates in the PCI alone group were lower than expected, the companies noted.

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