Cogentus to begin phase III program of antiplatelet therapy
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.
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.