Cogentus Pharmaceuticals is initiating a phase III clinical program to evaluate the efficacy and safety of its combination antiplatelet therapy CGT-2168.
The program will enroll more than 4,000 patients at hundreds of sites in the United States, Canada, Europe and South America, according the Menlo Park, Calif.-based Cogentus.
The program includes the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT)-1 and COGENT-2 trials, designed to measure the incidence of upper gastrointestinal bleeding and ulcers in patients who take CGT-2168 and aspirin compared with patients who take clopidogrel, Plavix, and aspirin.
According to Cogentus, CGT-2168 is a once-daily pill that combines the antiplatelet agent Plavix, marketed by Bristol-Myers Squibb and Sanofi-Aventis, with a gastroprotectant (omeprazole). The company said the product is designed to reduce the gastrointestinal side effects commonly associated with antiplatelet therapy.