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NCT01076764 · ClinicalTrials.gov registry record · Phase 3
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 13,220
- Enrollment target
NCT01076764 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 13,220 participants.
The verdict
NCT01076764, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13,220 participants
- Enrollment target
Study Summary
Primary Objective: * To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: * To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide * To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide * To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide * To document the safety of Otamixaban as compared to UFH + eptifibatide * To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide
Interventions
- DRUG Eptifibatide
- DRUG Otamixaban
- DRUG Placebo (for Otamixaban)
- DRUG UFH
- DRUG Placebo (for UFH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,220 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01076764
The ClinicalTrials.gov registry entry for NCT01076764 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 13,220 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 5 interventions - of which Eptifibatide is the first listed.
NCT01076764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01076764 about?
NCT01076764 is a clinical study titled "Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy". Primary Objective: * To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: * To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otami...
What is the current status of trial NCT01076764?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13,220 participants. The study started on 2010-04. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01076764?
The interventions under investigation include: Eptifibatide (DRUG), Otamixaban (DRUG), Placebo (for Otamixaban) (DRUG), UFH (DRUG), Placebo (for UFH) (DRUG).
Who is sponsoring clinical trial NCT01076764?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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