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NCT01120314 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01120314: Completed Phase 1 study, sponsored by Sanofi.
NCT01120314 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01120314, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
Primary Objective: * To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: * To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
Interventions
- DRUG OTAMIXABAN (XRP0673)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01120314 record still lists
NCT01120314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which OTAMIXABAN (XRP0673) is the first listed.
NCT01120314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01120314 about?
NCT01120314 is a clinical study titled "Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment". Primary Objective: * To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban. Secondary Objective: * To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal rena...
What is the current status of trial NCT01120314?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2010-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01120314?
The interventions under investigation include: OTAMIXABAN (XRP0673) (DRUG).
Who is sponsoring clinical trial NCT01120314?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01120314's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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