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NCT00077805 · ClinicalTrials.gov registry record · Phase 4
PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
NCT00077805 is a Phase 4 study that has completed, run by Sanofi.
The verdict
NCT00077805, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
Study Summary
Primary objective: * To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke. Secondary objectives: * To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization * To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization * To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke
Interventions
- DRUG Enoxaparin sodium
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00077805
The ClinicalTrials.gov registry entry for NCT00077805 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. 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 Enoxaparin sodium is the first listed.
NCT00077805 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00077805 about?
NCT00077805 is a clinical study titled "PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)". Primary objective: * To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke. Secondary objectives: * To compare the incidence of VTE between the 2 treatment gr...
What is the current status of trial NCT00077805?
This trial is currently completed. It is a Phase 4 study. The study started on 2003-08.
What interventions are being tested in trial NCT00077805?
The interventions under investigation include: Enoxaparin sodium (DRUG).
Who is sponsoring clinical trial NCT00077805?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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