Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 4,673 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00070655
The ClinicalTrials.gov registry entry for NCT00070655 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,673 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SR34006 (idraparinux sodium) Injection is the first listed.
NCT00070655 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.