21.05.2008 12:30:00
|
ACHIEVE Imaging Study Discontinued
Merck & Co., Inc. today announced the discontinuation of 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 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 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.
"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, M.D. Ph.D., 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."
"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"
said Christie Ballantyne, M.D., Chief, Section of Atherosclerosis and
Vascular Medicine, Baylor College of Medicine and the Methodist DeBakey
Heart Center. "There is significant value in evaluating the effect of
medicines in the right patient population using this technology."
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.
Merck remains committed to the development of MK-0524A and, as such, all
other ongoing clinical studies, including the 20,000 patient outcomes
study known as HPS2-THRIVE, continue unchanged.
About ACHIEVE
ACHIEVE was designed to evaluate the effects of MK-0524A on cIMT in
patients with HeFH. The study was initiated in October 2006 and
approximately one-third of the planned 900 patients are currently
enrolled. For more information, go to www.clinicaltrials.gov.
The ACHIEVE Steering Committee met on May 14, 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, M.D., Merck Research Laboratories,
Rahway, NJ.
About Merck
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.
Forward-Looking Statement
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.
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