Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
- Registration Number
- NCT00995410
- Lead Sponsor
- POZEN
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PA32540 tablet PA32540 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
- Primary Outcome Measures
Name Time Method Number of Subjects Monitored for Long-term Safety of PA32540 12 months Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).
- Secondary Outcome Measures
Name Time Method Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation 12 months Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation
Trial Locations
- Locations (1)
Pozen
🇺🇸Chapel Hill, North Carolina, United States