The study was discontinued at the recommendation of the steering committee based on its review and evaluation of scientific data from recent carotid intima-media thickness (cIMT) studies. This decision follows the March 29, 2008 steering committee recommendation to put patient enrollment on hold.
The action to discontinue the study is not related to the recent not approvable FDA letter on MK-0524A, and preliminary data did not suggest any safety concerns. Merck has notified study investigators of the decision and is in the process of informing regulatory agencies.
Christie Ballantyne, chief for section of atherosclerosis and vascular medicine at Baylor College of Medicine, said: “The steering committee strongly believes that atherosclerosis imaging trials can provide valuable information to scientists and physicians about the risk of vascular disease and the effectiveness of treatments.”