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Boehringer Ingelheim
Enrollment in study of TNKase/ Metalyse used prior to angioplasty suspended
July 6th, 2005
Boehringer Ingelheim and Genentech, Inc., (DNA) confirmed that patient enrollment into ASSENT 4 PCI, a randomized, exploratory phase IIIb/IV clinical study of the single-bolus thrombolytic TNKase/ Metalyse (tenecteplase) in combination with an early planned percutaneous coronary intervention (PCI) versus PCI alone in patients with large acute myocardial infarctions, was suspended pending further analysis of the available study data. This suspension followed the recommendation of an independent Data Safety Monitoring Board (DSMB) during a planned interim data review. A preliminary data analysis showed that the mortality rate in those treated with...
Source: Biotech Week (2005-07-06)
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