A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers.
Phase of Trial: Phase III
Latest Information Update: 09 Jan 2017
At a glance
- Drugs Aspirin/omeprazole (Primary) ; Aspirin
- Indications Cardiovascular disorders
- Focus Adverse reactions; Registrational
- Sponsors POZEN
- 09 Jan 2017 According to an Aralez Pharmaceuticals Inc. media release, the company has submitted a Marketing Authorization Application (MAA) to the EMA for PA10040 (YOSPRALA) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers based on results from three trials (CTPs 700036117, 700048158 and 700225598)
- 14 Nov 2016 According to an Aralez Pharmaceuticals media release, results of pooled post hoc analysis from this and other phase III study (Profile 48158) were presented at the annual American Heart Association Scientific Sessions.
- 14 Nov 2016 Results of pooled post hoc analysis from this and other phase III study (Profile 48158), published in an Aralez Pharmaceuticals media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History