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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: Completed Phase 2 study, sponsored by Sanofi.

NCT00317395 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 3,241 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2337% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 3,241 participants
Start Date 2006-06
Est. Completion 2009-03
Phase Phase 2
Sanofi

713 total trials

What the finished NCT00317395 record still lists

NCT00317395 is an interventional study that assigns participants to a tested intervention. Its 3,241 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2337% higher).

The record links to 0 conditions, and to 3 interventions - of which eptifibatide is the first listed.

NCT00317395 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00317395's enrollment target sits among peer trials

3,241 6th of 2000 higher than 1,995 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00317395, the US trial registry maintained by the National Library of Medicine. NCT00317395 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.