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NCT00070655 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,673
- Enrollment target
NCT00070655: Completed Phase 3 study, sponsored by Sanofi.
NCT00070655 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 4,673 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (505% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00070655, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,673 participants
- Enrollment target
Study Summary
This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol. The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets. Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.
Interventions
- DRUG SR34006 (idraparinux sodium) Injection
- DRUG vitamin K antagonist (warfarin or acenocoumarol) tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,673 participants |
| Start Date | 2003-09 |
| Est. Completion | 2006-03 |
| Phase | Phase 3 |
What the finished NCT00070655 record still lists
NCT00070655 is an interventional study that assigns participants to a tested intervention. Its 4,673 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 (505% higher).
The record links to 0 conditions, and to 2 interventions - of which SR34006 (idraparinux sodium) Injection is the first listed.
NCT00070655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00070655 about?
NCT00070655 is a clinical study titled "Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)". This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the bod...
What is the current status of trial NCT00070655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,673 participants. The study started on 2003-09. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00070655?
The interventions under investigation include: SR34006 (idraparinux sodium) Injection (DRUG), vitamin K antagonist (warfarin or acenocoumarol) tablets (DRUG).
Who is sponsoring clinical trial NCT00070655?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00070655's enrollment target sits among peer trials
4,673 54th of 2000 higher than 1,947 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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