Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers

Summary

This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure to PA32540.

Timeline

Start

2009-10

Primary completion

2011-05

Completion

2011-05

Publications

• Goldstein JL, Whellan DJ, Scheiman JM, Cryer BL, Eisen GM, Lanas A, Fort JG. Long-Term Safety of a Coordinated Delivery Tablet of Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients at GI Risk. Cardiovasc Ther. 2016 Apr;34(2):59-66. doi: 10.1111/1755-5922.12172.

Drugs

Indications