NCT00557921

Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)

A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: Cogentus Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens. The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease. Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

Conditions

• Acute Coronary Syndrome
• Myocardial Infarction
• Coronary Artery Disease
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin	(CGT-2168 active and Comparator placebo, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)
DRUG	Plavix (clopidogrel 75 mg) and aspirin	(CGT-2168 placebo and Comparator active, one capsule each daily; and enteric coated aspirin at daily dose level assigned by study physician)

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-11-14
• Last updated: 2009-01-28

Locations

491 sites across 16 countries: United States, Australia, Bulgaria, Canada, Chile, Czechia, France, Germany, Hungary, Italy, Mexico, Poland, Puerto Rico, Romania, Slovakia, Ukraine