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NCT00071279 · ClinicalTrials.gov registry record · Phase 3
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,215
- Enrollment target
NCT00071279 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,215 participants.
The verdict
NCT00071279, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,215 participants
- Enrollment target
Study Summary
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur. In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo. Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
Interventions
- DRUG SR34006 (idraparinux sodium) Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,215 participants |
| Start Date | 2003-11 |
| Est. Completion | 2005-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00071279
The ClinicalTrials.gov registry entry for NCT00071279 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,215 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 1 intervention - of which SR34006 (idraparinux sodium) Injection is the first listed.
NCT00071279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00071279 about?
NCT00071279 is a clinical study titled "SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis". Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or...
What is the current status of trial NCT00071279?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,215 participants. The study started on 2003-11. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00071279?
The interventions under investigation include: SR34006 (idraparinux sodium) Injection (DRUG).
Who is sponsoring clinical trial NCT00071279?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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