A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation

Completed

Phase 4 Results

Summary of Purpose

This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 2 September 2015.

1 Dec 2011 12 Dec 2011 1 Jul 2014 1 Jul 2014 1 Sep 2015 6 Jul 2015
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Contacts