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NCT01126086 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT01126086: Completed Phase 1 study, sponsored by Sanofi.

NCT01126086 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01126086, a Phase 1 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

Primary Objective: \- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban. Secondary Objective: \- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.

Interventions

  • DRUG otamixaban XRP0673

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-05
Est. Completion 2011-04
Phase Phase 1
Sanofi

713 total trials

What the finished NCT01126086 record still lists

NCT01126086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 1 intervention - of which otamixaban XRP0673 is the first listed.

NCT01126086 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01126086 about?

NCT01126086 is a clinical study titled "Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment". Primary Objective: \- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban. Secondary Objective: \- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic functi...

What is the current status of trial NCT01126086?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-05. Estimated completion is 2011-04.

What interventions are being tested in trial NCT01126086?

The interventions under investigation include: otamixaban XRP0673 (DRUG).

Who is sponsoring clinical trial NCT01126086?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01126086's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01126086, the US trial registry maintained by the National Library of Medicine. NCT01126086 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.