The amendments are due to preliminary results from pharmacokinetic analyses, including patients and healthy volunteers, indicating that a dose adjustment may be appropriate for certain subpopulations. These protocol amendments should not be interpreted to represent the outcome of the overall prasugrel clinical development program, the companies said.
The two small Phase II pharmacodynamic studies compare the levels of inhibition of platelet aggregation in patients with coronary artery disease taking the investigational antiplatelet agent prasugrel or Bristol-Myers Squibb’s Plavix (clopidogrel). Neither study has an efficacy endpoint. Patient enrollment will resume as soon as additional analyses of pharmacokinetic and clinical data are completed, and the protocols are amended and approved by institutional review boards.
Anthony Ware, Lilly cardiovascular platform leader for prasugrel, said: “We are suspending enrollment in these two small pharmacodynamic trials so that we can amend current protocols. These amendments are strictly protocol-related and do not provide a basis for inferring overall outcomes of other prasugrel trials.”