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A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa 150 mg b.i.d., 110 mg b.i.d., or 75 mg b.i.d. for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (NVAF)

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Trial Profile

A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa 150 mg b.i.d., 110 mg b.i.d., or 75 mg b.i.d. for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (NVAF)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 09 May 2019

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At a glance

  • Drugs Dabigatran etexilate (Primary) ; Pantoprazole
  • Indications Gastrointestinal disorders; Stroke; Thromboembolism
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 01 Dec 2016 Primary endpoint (The Rate of Complete Effectiveness of Initial GIS Management Strategy) has not been met,according to the results published in the Cardiology and Therapy.
    • 01 Dec 2016 Results published in the Cardiology and Therapy
    • 06 Aug 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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