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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01493557
The ClinicalTrials.gov registry entry for NCT01493557 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,067 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,992-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (64% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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