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First Patient Enrolled In Cogentus Pharmaceuticals' Pivotal Phase 3 Trial Of Novel Combination Medicine
Cogentus Pharmaceuticals,
Inc. announced that the first patient has been enrolled in the
company's pivotal Phase 3 study of its novel combination medicine CGT-2168.
The patient entered the study at the Mobile Heart Specialists P.C. in
Mobile, Ala.
The study will evaluate the antiplatelet medicine CGT-2168, which is a
combination of clopidogrel (currently marketed by Bristol-Myers Squibb Co.
and Sanofi-Aventis as Plavix(R)) and a gastroprotectant (omeprazole) in a
single pill. Developed by Cogentus, CGT-2168 is designed to provide
protective cardiovascular benefits while reducing potentially serious
gastrointestinal side effects commonly associated with dual antiplatelet
therapy.
"This is an important milestone for Cogentus that holds promise for the
millions of patients who are prescribed dual antiplatelet treatment," said
Cogentus Chairman and Chief Executive Officer Mark A. Goldsmith, M.D.,
Ph.D. "We believe CGT-2168 has the potential to reduce significantly the
gastrointestinal side effects that can cause patients to interrupt their
treatment and further compromise their health status."
Antiplatelet therapy is an integral part of treating patients with
acute coronary syndrome and has been shown to be effective in preventing
major cardiovascular events. However, the combination of clopidogrel and
aspirin is associated with gastrointestinal bleeding, which in some cases
requires hospitalization and can even result in death.
The global trial is known as COGENT-1 (Clopidogrel and the Optimization
of Gastrointestinal Events Trials) and is part of a clinical program
expected to enroll more than 4,000 patients at hundreds of sites in the
United States, Canada, Europe and South America.
Among patients who participate in the study, approximately half will
receive clopidogrel and aspirin; the other half will receive CGT-2168
(clopidogrel plus omeprazole) and aspirin. Patients will be assessed
regularly for any gastrointestinal side effects such as bleeding and ulcers
as well as receive ongoing monitoring of their cardiovascular status.
Physicians and patients interested in obtaining more information about
COGENT-1 should go to http://www.clinicaltrials.gov.
ABOUT COGENTUS
Cogentus Pharmaceuticals, Inc., of Menlo Park, CA, is a privately held
specialty pharmaceutical company founded in 2006. Cogentus
(http://www.cogentus.net) is committed to becoming a premier developer of
innovative, fixed-dose combination prescription medicines serving unmet
medical needs that drive significant commercial opportunities.
Plavix(R) is a registered trademark of Sanofi-Aventis.
Cogentus Pharmaceuticals Inc.
http://www.cogentus.net
View drug information on PLAVIX.
În primul rând de pacienþi înrolaþi în Cogentus Pharmaceuticals "pivot de fazã 3 proces al Novel Combinaþie Medicina - First Patient Enrolled In Cogentus Pharmaceuticals' Pivotal Phase 3 Trial Of Novel Combination Medicine - articole medicale engleza - startsanatate