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NCT00317395 · ClinicalTrials.gov registry record · Phase 2
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 3,241
- Enrollment target
NCT00317395 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 3,241 participants.
The verdict
NCT00317395, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3,241 participants
- Enrollment target
Study Summary
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous \[IV\] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy. Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).
Interventions
- DRUG eptifibatide
- DRUG Otamixaban (XRP0673)
- DRUG unfractionated heparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,241 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00317395
The ClinicalTrials.gov registry entry for NCT00317395 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3,241 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 3 interventions - of which eptifibatide is the first listed.
NCT00317395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00317395 about?
NCT00317395 is a clinical study titled "Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome". Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous \[IV\] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy. Secondary objectives: To evaluate safety and assess pharm...
What is the current status of trial NCT00317395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3,241 participants. The study started on 2006-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00317395?
The interventions under investigation include: eptifibatide (DRUG), Otamixaban (XRP0673) (DRUG), unfractionated heparin (DRUG).
Who is sponsoring clinical trial NCT00317395?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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