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NCT00680186 · ClinicalTrials.gov registry record · Phase 3

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
2,589
Enrollment target

NCT00680186: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT00680186 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,589 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00680186, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
2,589 participants
Enrollment target

Study Summary

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Primary Outcome

All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.

Interventions

  • DRUG Warfarin
  • DRUG Dabigatran etexilate

Trial Details

FieldValue
Enrollment Target 2,589 participants
Start Date 2008-04
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT00680186 record still lists

NCT00680186 is an interventional study that assigns participants to a tested intervention. Its 2,589 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 (235% higher).

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

NCT00680186 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00680186 about?

NCT00680186 is a clinical study titled "Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)". The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primar...

What is the current status of trial NCT00680186?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,589 participants. The study started on 2008-04.

What interventions are being tested in trial NCT00680186?

The interventions under investigation include: Warfarin (DRUG), Dabigatran etexilate (DRUG).

Who is sponsoring clinical trial NCT00680186?

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 NCT00680186's enrollment target sits among peer trials

2,589 85th of 2000 higher than 1,916 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 NCT00680186, the US trial registry maintained by the National Library of Medicine. NCT00680186 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.