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
Phase of Trial: Phase III
Latest Information Update: 28 Mar 2016
At a glance
- Drugs Aspirin/omeprazole (Primary)
- Indications Cardiovascular disorders; Embolism and thrombosis; NSAID-induced gastric damage; NSAID-induced ulcer
- Focus Adverse reactions; Registrational
- Sponsors POZEN
- 28 Mar 2016 According to an Aralez media release, the US FDA has accepted the NDA for aspirin/omerperazole [Yosprala; PA32540/PA8140] for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
- 08 Jun 2011 Actual end date (May 2011) added as reported by ClinicalTrials.gov.
- 08 Jun 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History