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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01493557

Public ClinicalTrials.gov record NCT01493557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 6:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT01493557
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
1,067 participants

Conditions and interventions

Interventions

  • pantoprazole Drug
  • Pradaxa (dabigatran etexilate) Drug
  • Pradaxa, within 30 minutes after a meal Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2011
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014
Last update posted
Oct 4, 2015

2011 – 2014

United States locations

U.S. sites
81
U.S. states
34
U.S. cities
78
Facility City State ZIP Site status
1160.128.1046 Boehringer Ingelheim Investigational Site Birmingham Alabama
1160.128.1045 Boehringer Ingelheim Investigational Site Huntsville Alabama
1160.128.1003 Boehringer Ingelheim Investigational Site Mobile Alabama
1160.128.1093 Boehringer Ingelheim Investigational Site Chandler Arizona
1160.128.1067 Boehringer Ingelheim Investigational Site Hot Springs Arkansas
1160.128.1103 Boehringer Ingelheim Investigational Site Mesa California
1160.128.1094 Boehringer Ingelheim Investigational Site Newport Beach California
1160.128.1042 Boehringer Ingelheim Investigational Site San Diego California
1160.128.1005 Boehringer Ingelheim Investigational Site Colorado Spring Colorado
1160.128.1023 Boehringer Ingelheim Investigational Site Denver Colorado
1160.128.1016 Boehringer Ingelheim Investigational Site Bridgeport Connecticut
1160.128.1066 Boehringer Ingelheim Investigational Site Bridgeport Connecticut
1160.128.1018 Boehringer Ingelheim Investigational Site Guilford Connecticut
1160.128.1050 Boehringer Ingelheim Investigational Site Norwalk Connecticut
1160.128.1057 Boehringer Ingelheim Investigational Site Waterbury Connecticut
1160.128.1085 Boehringer Ingelheim Investigational Site Washington D.C. District of Columbia
1160.128.1111 Boehringer Ingelheim Investigational Site Atlantis Florida
1160.128.1032 Boehringer Ingelheim Investigational Site Brandon Florida
1160.128.1021 Boehringer Ingelheim Investigational Site Coral Springs Florida
1160.128.1027 Boehringer Ingelheim Investigational Site Daytona Beach Florida
1160.128.1019 Boehringer Ingelheim Investigational Site Jacksonville Florida
1160.128.1062 Boehringer Ingelheim Investigational Site Jacksonville Florida
1160.128.1054 Boehringer Ingelheim Investigational Site Largo Florida
1160.128.1097 Boehringer Ingelheim Investigational Site Miami Florida
1160.128.1109 Boehringer Ingelheim Investigational Site Miami Florida
1160.128.1087 Boehringer Ingelheim Investigational Site Orlando Florida
1160.128.1058 Boehringer Ingelheim Investigational Site Pensacola Florida
1160.128.1007 Boehringer Ingelheim Investigational Site Port Charlotte Florida
1160.128.1060 Boehringer Ingelheim Investigational Site Rockledge Florida
1160.128.1096 Boehringer Ingelheim Investigational Site Columbus Georgia
1160.128.1068 Boehringer Ingelheim Investigational Site Roswell Georgia
1160.128.1076 Boehringer Ingelheim Investigational Site Coeur d'Alene Idaho
1160.128.1073 Boehringer Ingelheim Investigational Site Melrose Park Illinois
1160.128.1048 Boehringer Ingelheim Investigational Site Winfield Illinois
1160.128.1105 Boehringer Ingelheim Investigational Site Hammond Indiana
1160.128.1029 Boehringer Ingelheim Investigational Site Indianapolis Indiana
1160.128.1079 Boehringer Ingelheim Investigational Site Overland Park Kansas
1160.128.1008 Boehringer Ingelheim Investigational Site Baton Rouge Louisiana
1160.128.1025 Boehringer Ingelheim Investigational Site Auburn Maine
1160.128.1100 Boehringer Ingelheim Investigational Site Biddeford Maine
1160.128.1041 Boehringer Ingelheim Investigational Site Columbia Maryland
1160.128.1012 Boehringer Ingelheim Investigational Site Salisbury Maryland
1160.128.1015 Boehringer Ingelheim Investigational Site Rochester Hills Michigan
1160.128.1004 Boehringer Ingelheim Investigational Site Tupelo Mississippi
1160.128.1014 Boehringer Ingelheim Investigational Site Columbia Missouri
1160.128.1047 Boehringer Ingelheim Investigational Site Kansas City Missouri
1160.128.1075 Boehringer Ingelheim Investigational Site St Louis Missouri
1160.128.1069 Boehringer Ingelheim Investigational Site Great Falls Montana
1160.128.1011 Boehringer Ingelheim Investigational Site Kalispell Montana
1160.128.1092 Boehringer Ingelheim Investigational Site Lincoln Nebraska
1160.128.1059 Boehringer Ingelheim Investigational Site Omaha Nebraska
1160.128.1039 Boehringer Ingelheim Investigational Site Elmer New Jersey
1160.128.1035 Boehringer Ingelheim Investigational Site Flemington New Jersey
1160.128.1036 Boehringer Ingelheim Investigational Site Albuquerque New Mexico
1160.128.1063 Boehringer Ingelheim Investigational Site Hawthorne New York
1160.128.1078 Boehringer Ingelheim Investigational Site Mineola New York
1160.128.1001 Boehringer Ingelheim Investigational Site Poughkeepsie New York
1160.128.1022 Boehringer Ingelheim Investigational Site Asheville North Carolina
1160.128.1052 Boehringer Ingelheim Investigational Site Gastonia North Carolina
1160.128.1071 Boehringer Ingelheim Investigational Site Statesville North Carolina
1160.128.1091 Boehringer Ingelheim Investigational Site Gallipolis Ohio
1160.128.1107 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
1160.128.1053 Boehringer Ingelheim Investigational Site Bend Oregon
1160.128.1033 Boehringer Ingelheim Investigational Site Hillsboro Oregon
1160.128.1037 Boehringer Ingelheim Investigational Site Altoona Pennsylvania
1160.128.1034 Boehringer Ingelheim Investigational Site Camp Hill Pennsylvania
1160.128.1010 Boehringer Ingelheim Investigational Site Langhorne Pennsylvania
1160.128.1056 Boehringer Ingelheim Investigational Site Pittsburgh Pennsylvania
1160.128.1065 Boehringer Ingelheim Investigational Site Uniontown Pennsylvania
1160.128.1043 Boehringer Ingelheim Investigational Site Charleston South Carolina
1160.128.1040 Boehringer Ingelheim Investigational Site Rapid City South Dakota
1160.128.1006 Boehringer Ingelheim Investigational Site Austin Texas
1160.128.1104 Boehringer Ingelheim Investigational Site Houston Texas
1160.128.1061 Boehringer Ingelheim Investigational Site McKinney Texas
1160.128.1090 Boehringer Ingelheim Investigational Site New Braunfels Texas
1160.128.1082 Boehringer Ingelheim Investigational Site San Antonio Texas
1160.128.1102 Boehringer Ingelheim Investigational Site Layton Utah
1160.128.1077 Boehringer Ingelheim Investigational Site Danville Virginia
1160.128.1064 Boehringer Ingelheim Investigational Site Falls Church Virginia
1160.128.1110 Boehringer Ingelheim Investigational Site Manassas Virginia
1160.128.1099 Boehringer Ingelheim Investigational Site Norfolk Virginia

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01493557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 4, 2015 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01493557 live on ClinicalTrials.gov.

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