Update on Merck & Co., Inc. (MRK)'s Investigational Extended-Release Niacin/Laropiprant; Patient Enrollment Placed on Hold
CHICAGO--(BUSINESS WIRE)--Merck & Co., Inc. today announced that, based on the recommendation of the Steering Committee for ACHIEVE (An Assessment of Coronary Health Using an Intima-Media Thickness Endpoint for Vascular Effects), further patient enrollment in the study has been placed on hold. The action will allow the Steering Committee to evaluate the current study design in light of scientific data from recent intima-media thickness (IMT) studies.
Ongoing clinical studies with Merck's investigational extended-release niacin/laropiprant (CORDAPTIVEâ„¢), including the 20,000 patient outcomes study known as HPS2-THRIVE, continue unchanged.
"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, M.D. Ph.D., Chair, ACHIEVE Steering Committee, Academisch Medisch Centrum, Amsterdam, The Netherlands. The Committee expects to meet in the near future to review additional analyses and options, and advise on a path forward for ACHIEVE.
"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, M.D., Chief, Section of Atherosclerosis and Vascular Medicine, Baylor College of Medicine and the Methodist DeBakey Heart Center.
Merck has begun to notify study investigators and regulatory agencies of this decision.
ACHIEVE is a study designed to evaluate the effects of CORDAPTIVE on carotid IMT in patients with familial hypercholesterolemia. The study was initiated in October 2006 and approximately one-third of the planned 900 patients are currently enrolled. ACHIEVE is underway in 17 countries around the world. For more information, go to www.clinicaltrials.gov.
The ACHIEVE Steering Committee met on Saturday, March 29, 2008. The Steering Committee members are: Kastelein; Ballantyne; David Marais, M.D., Groote Schuur Hospital & University of Cape Town, South Africa; Claude Gagne, M.D., Clinic of Lipid Disease of Quebec Inc.; Jonathan Isaacsohn, MedPace, Inc.; and Yale Mitchel, Ph.D., Merck Research Laboratories, Rahway, NJ.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.