Singapore, May 22, 2008: American pharma giant Merck has discontinued ACHIEVE (An Assessment of Coronary Health Using an Intima-Media Thickness Endpoint for Vascular Effects), an imaging study evaluating MK-0524A (ER niacin/laropiprant) in patients with Heterozygous Familial Hypercholesterolemia (HeFH).
The study was discontinued after Merck said wrong patient population was identified as the target for the drug. In a release issued yesterday, Merck said the study was stalled at recommendation of the Steering Committee based on its review and evaluation of scientific data from recent carotid intima-media thickness (cIMT) studies.
"It was clear from the Steering Committee's review of pooled data from recently completed cIMT studies of other medicines that the patient population being studied in ACHIEVE was no longer the correct population to test the primary study hypothesis of IMT progression," said John Kastelein, Chair, ACHIEVE Steering Committee, Academisch Medisch Centrum, Amsterdam, The Netherlands. "For that reason, the Committee recommended that ACHIEVE be stopped and a new imaging trial be considered in a more appropriate patient population."
Merck has notified study investigators of the decision and is in the process of informing regulatory agencies. The Steering Committee will present and publish the results of their review of scientific data from several cIMT studies in HeFH patients at an appropriate scientific forum in the future.
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