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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 25 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01126086
The ClinicalTrials.gov registry entry for NCT01126086 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 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.
NCT01126086 reports 0 study locations.
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.
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