# 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

> **NCT01493557** · PHASE4 · COMPLETED · sponsor: **Boehringer Ingelheim** · enrollment: 1067 (actual)

## Conditions studied

- Atrial Fibrillation

## Interventions

- **DRUG:** pantoprazole
- **DRUG:** Pradaxa (dabigatran etexilate)
- **DRUG:** Pradaxa, within 30 minutes after a meal
- **DRUG:** Pradaxa (dabigatran etexilate)

## Key facts

- **NCT ID:** NCT01493557
- **Lead sponsor:** Boehringer Ingelheim
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-12
- **Primary completion:** 2014-07
- **Final completion:** 2014-07
- **Target enrollment:** 1067 (ACTUAL)
- **Last updated:** 2015-10-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01493557

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01493557, "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". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT01493557. Licensed CC0.

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