Late-stage Cordaptive trial stalls on IMT issue

US drug major Merck & Co says that, based on the recommendation of the steering committee for the ACHIEVE study, further patient enrollment has been placed on hold to allow it to evaluate the current design in light of intima-media thickness data from the failed ENHANCE trial. Ongoing clinical studies with Merck's investigational Cordaptive (extended-release niacin/laropiprant), including the 20,000 patient outcomes study known as HPS2-THRIVE, continue unchanged. ACHIEVE is designed to evaluate the effects of the agent on carotid IMT in familial hypercholesterolemia, which is similar to the ENHANCE study, which showed that Vytorin (ezetimibe and high-dose simvastatin) was no more effective than Merck's off-patent statin Zocor (simvastatin) at slowing the clogging up of arteries, as measured by IMT (Marketletter January 15).

ACHIEVE was initiated in October 2006 and one third of the planned 900 patients are currently enrolled. "Since ACHIEVE was originally designed, the understanding of carotid IMT studies has evolved, leading the committee to decide to take this action," said John Kastelein, chairman of the steering committee, which expects to meet in the near future to review additional analyses and options, and advise on a path forward for the stalled trial. "In the meantime, patients currently enrolled in ACHIEVE will continue to be followed according to the protocol and all study data will remain blinded," said Christie Ballantyne, chief, Section of Atherosclerosis and Vascular Medicine, Baylor College of Medicine and the Methodist DeBakey Heart Center. Merck says it has begun to notify study investigators and regulatory agencies of this decision.