Conditions: Aspirin-Associated Gastric Ulcers
Keywords: Subjects Who are at Risk for Developing Aspirin-ASA Subject must have a pre-existing condition for which aspirin is already indicated Gastric Ulcers
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 380
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily

Interventions: intervention 1: PA32540
Intervention descriptions: intervention 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily

Protocol document: