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NCT00262600 · ClinicalTrials.gov registry record · Phase 3
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
A Phase 3 study of Stroke and Atrial Fibrillation, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 18,113
- Enrollment target
- 20
- Study locations
NCT00262600: Completed Phase 3 study of Stroke and Atrial Fibrillation, sponsored by Boehringer Ingelheim.
NCT00262600 is a Phase 3 study of Stroke and Atrial Fibrillation that has completed, run by Boehringer Ingelheim. The registered enrollment target is 18,113 participants, above the 11,977-participant average among 454 other Stroke trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00262600, a Phase 3 study of Stroke and Atrial Fibrillation, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18,113 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
Primary Outcome
Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
Conditions Studied
Interventions
- DRUG warfarin
- DRUG Dabigatran dose 1
- DRUG Dabigatran dose 2
Study Locations (20)
Arkansas
- 1160.26.0038 Boehringer Ingelheim Investigational Site - Hot Springs
- 1160.26.0302 Boehringer Ingelheim Investigational Site - Jonesboro
- 1160.26.0121 Boehringer Ingelheim Investigational Site - Little Rock
- 1160.26.0191 Boehringer Ingelheim Investigational Site - Little Rock
- 1160.26.0204 Boehringer Ingelheim Investigational Site - Little Rock
- 1160.26.0213 Boehringer Ingelheim Investigational Site - Little Rock
- 1160.26.0455 Boehringer Ingelheim Investigational Site - Little Rock
Alabama
- 1160.26.0009 Boehringer Ingelheim Investigational Site - Birmingham
- 1160.26.0046 Boehringer Ingelheim Investigational Site - Birmingham
- 1160.26.0057 Boehringer Ingelheim Investigational Site - Birmingham
- 1160.26.0211 Boehringer Ingelheim Investigational Site - Birmingham
- 1160.26.0206 Boehringer Ingelheim Investigational Site - Huntsville
- 1160.26.0115 Boehringer Ingelheim Investigational Site - Mobile
Arizona
- 1160.26.0104 Boehringer Ingelheim Investigational Site - Lake Havasu City
- 1160.26.0304 Boehringer Ingelheim Investigational Site - Peoria
- 1160.26.0185 Boehringer Ingelheim Investigational Site - Tucson
- 1160.26.0305 Boehringer Ingelheim Investigational Site - Tucson
California
- 1160.26.0388 Boehringer Ingelheim Investigational Site - Anaheim
- 1160.26.0441 Boehringer Ingelheim Investigational Site - Carmichael
- 1160.26.0145 Boehringer Ingelheim Investigational Site - French Camp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18,113 participants |
| Start Date | 2005-12 |
| Phase | Phase 3 |
What the finished NCT00262600 record still lists
NCT00262600 is an interventional study that assigns participants to a tested intervention. Its 18,113 participants enrollment target places it among the larger protocols in the corpus, above the 11,977-participant average among 454 other Stroke trials with a reported enrollment target (51% higher).
The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 3 interventions - of which warfarin is the first listed.
NCT00262600 names 20 study sites across 4 states, led by Arkansas, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00262600 about?
NCT00262600 is a clinical study titled "Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate". The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
What is the current status of trial NCT00262600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18,113 participants. The study started on 2005-12.
What conditions does trial NCT00262600 study?
This clinical trial studies the following conditions: Stroke, Atrial Fibrillation.
What interventions are being tested in trial NCT00262600?
The interventions under investigation include: warfarin (DRUG), Dabigatran dose 1 (DRUG), Dabigatran dose 2 (DRUG).
Who is sponsoring clinical trial NCT00262600?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00262600 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
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 NCT00262600's enrollment target sits among peer trials
18,113 7th of 454 higher than 448 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke 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.
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