Aspirin-Associated Gastric Ulcers Clinical Trial
Official title:
A 12-Month, Phase 3, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
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.
PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers. This study is designed to provide long-term safety data for PA32540 in order to gain regulatory approval to make PA32540 available for clinical use in this subject population. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment