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

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

Completed
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
  • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top