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NCT00808067 · ClinicalTrials.gov registry record · Phase 3

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
5,897
Enrollment target

NCT00808067: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT00808067 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 5,897 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (664% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00808067, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
5,897 participants
Enrollment target

Study Summary

The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes

Primary Outcome

Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrom

Interventions

  • DRUG dabigatran dose 1
  • DRUG dabigatran dose 2

Trial Details

FieldValue
Enrollment Target 5,897 participants
Start Date 2008-11
Est. Completion 2012-12
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT00808067 record still lists

NCT00808067 is an interventional study that assigns participants to a tested intervention. Its 5,897 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (664% higher).

The record links to 0 conditions, and to 2 interventions - of which dabigatran dose 1 is the first listed.

NCT00808067 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00808067 about?

NCT00808067 is a clinical study titled "RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial". The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes

What is the current status of trial NCT00808067?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,897 participants. The study started on 2008-11. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00808067?

The interventions under investigation include: dabigatran dose 1 (DRUG), dabigatran dose 2 (DRUG).

Who is sponsoring clinical trial NCT00808067?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00808067's enrollment target sits among peer trials

5,897 42nd of 2000 higher than 1,959 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT00808067, the US trial registry maintained by the National Library of Medicine. NCT00808067 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.