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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 48 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01120314
The ClinicalTrials.gov registry entry for NCT01120314 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 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 1 intervention - of which OTAMIXABAN (XRP0673) is the first listed.
NCT01120314 reports 0 study locations.
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.
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