NCT00995410

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aspirin-Associated Gastric Ulcers

Interventions

Type	Name	Description
DRUG	PA32540	PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-10-15
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

1 site across 1 country: United States