Conditions: Gastric Ulcer
Keywords: PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 519
Healthy volunteers: no

Brief summary:
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.

Detailed description:

Arms:
arm 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD) arm 2: EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)

Interventions: intervention 1: PA32540 intervention 2: EC-Aspirin 325 mg
Intervention descriptions: intervention 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole intervention 2: The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)

Protocol document: