Cogentus initiates Ph III CGT-2168 trial
The USA's Cogentus Pharmaceuticals has enrolled the first patient in a pivotal Phase III study of its novel combination medicine CGT-2168. The trial will evaluate the antiplatelet therapy, which is a combination of clopidogrel (currently marketed by Bristol-Myers Squibb and Sanofi-Aventis as Plavix) and the gastroprotectant omeprazole in a single pill. The agent is designed to provide protective cardiovascular benefits while reducing the potentially-serious gastrointestinal side effects commonly associated with dual antiplatelet therapy, Cogentus noted.
Company chief executive Mark Goldsmith, said: "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."
The global trial is known as COGENT-1 and is part of a clinical program expected to enroll more than 4,000 patients at hundreds of sites in the USA, Canada, Europe and South America.
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