Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01493557 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study of Atrial Fibrillation, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,067
- Enrollment target
- 20
- Study locations
NCT01493557: Completed Phase 4 study of Atrial Fibrillation, sponsored by Boehringer Ingelheim.
NCT01493557 is a Phase 4 study of Atrial Fibrillation that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,067 participants, below the 2,992-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01493557, a Phase 4 study of Atrial Fibrillation, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,067 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.
Conditions Studied
Interventions
- DRUG pantoprazole
- DRUG Pradaxa (dabigatran etexilate)
- DRUG Pradaxa, within 30 minutes after a meal
Study Locations (20)
Connecticut
- 1160.128.1016 Boehringer Ingelheim Investigational Site - Bridgeport
- 1160.128.1066 Boehringer Ingelheim Investigational Site - Bridgeport
- 1160.128.1018 Boehringer Ingelheim Investigational Site - Guilford
- 1160.128.1050 Boehringer Ingelheim Investigational Site - Norwalk
- 1160.128.1057 Boehringer Ingelheim Investigational Site - Waterbury
Florida
- 1160.128.1111 Boehringer Ingelheim Investigational Site - Atlantis
- 1160.128.1032 Boehringer Ingelheim Investigational Site - Brandon
- 1160.128.1021 Boehringer Ingelheim Investigational Site - Coral Springs
- 1160.128.1027 Boehringer Ingelheim Investigational Site - Daytona Beach
Alabama
- 1160.128.1046 Boehringer Ingelheim Investigational Site - Birmingham
- 1160.128.1045 Boehringer Ingelheim Investigational Site - Huntsville
- 1160.128.1003 Boehringer Ingelheim Investigational Site - Mobile
California
- 1160.128.1103 Boehringer Ingelheim Investigational Site - Mesa
- 1160.128.1094 Boehringer Ingelheim Investigational Site - Newport Beach
- 1160.128.1042 Boehringer Ingelheim Investigational Site - San Diego
Colorado
- 1160.128.1005 Boehringer Ingelheim Investigational Site - Colorado Spring
- 1160.128.1023 Boehringer Ingelheim Investigational Site - Denver
Arizona
- 1160.128.1093 Boehringer Ingelheim Investigational Site - Chandler
Arkansas
- 1160.128.1067 Boehringer Ingelheim Investigational Site - Hot Springs
District of Columbia
- 1160.128.1085 Boehringer Ingelheim Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,067 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT01493557 record still lists
NCT01493557 is an interventional study that assigns participants to a tested intervention. Its 1,067 participants enrollment target places it among the larger protocols in the corpus, below the 2,992-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 3 interventions - of which pantoprazole is the first listed.
NCT01493557 names 20 study sites across 8 states, led by Connecticut, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01493557 about?
NCT01493557 is a clinical study titled "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". 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 w...
What is the current status of trial NCT01493557?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,067 participants. The study started on 2011-12. Estimated completion is 2014-07.
What conditions does trial NCT01493557 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT01493557?
The interventions under investigation include: pantoprazole (DRUG), Pradaxa (dabigatran etexilate) (DRUG), Pradaxa, within 30 minutes after a meal (DRUG).
Who is sponsoring clinical trial NCT01493557?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01493557 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01493557's enrollment target sits among peer trials
1,067 37th of 202 higher than 166 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
RECRUITING · Phase 4
-
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
RECRUITING · Phase 4
-
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
RECRUITING · Phase 4
-
Ondansetron for the Management of Atrial Fibrillation
RECRUITING · Phase 4
-
EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
ACTIVE NOT RECRUITING · Phase 4
-
Therapeutic Initial Heparin Dosing for Patients With Clots or Certain Heart Conditions Admitted to the Hospital
ACTIVE NOT RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04165798 · 1,065 participants
KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
- NCT06751043 · 1,072 participants · NA
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
- NCT06159673 · 1,074 participants · Phase 2
ACP-204 in Adults With Alzheimer's Disease Psychosis
- NCT05520762 · 1,060 participants · NA
Hospital Airway Resuscitation Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia