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Home Industry News Eli Lilly announces suspension to trial enrolment

Eli Lilly announces suspension to trial enrolment

25th October 2007

Eli Lilly has announced that the enrolment of new patients for two prasugrel studies has been suspended until protocol amendments have been completed and approved.

The two small, early-phase, prasugrel-related pharmacodynamic clinical trials will stop continuation due to the release of preliminary results from pharmacokinetic analyses which have indicated that a dose adjustment may be necessary for certain sub-populations.

J Anthony Ware, Eli Lilly cardiovascular platform leader for prasugrel, assured that the protocol amendments should not be interpreted to represent the outcome of the overall prasugrel clinical development programme.

“These amendments are strictly protocol-related and do not provide a basis for inferring overall outcomes of other prasugrel trials,” he stated.

The two Phase II pharmacodynamic studies have been designed to compare the levels of inhibition of platelet aggregation in patients with coronary artery disease who are taking the investigational agent prasugrel.

Eli Lilly has confirmed that the studies will resume once the protocols are amended and approved by institutional review boards.

Earlier this month, Eli Lilly announced that, following its recently-completed analysis of clinical trial data and discussions with regulators, it has updated the product labels for Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine Hcl).

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