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
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 management strategies, and data documenting the intensity and duration of the GIS will be collected.
Study identification
- NCT ID
- NCT01493557
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,067 participants
Conditions and interventions
Conditions
Interventions
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
- Dec 2011 (Type not available)
- Primary completion
- Jul 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- Oct 5, 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 5, 2015 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01493557 live on ClinicalTrials.gov.