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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 30 Mar 2016

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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

Most Recent Events

  • 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.

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