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NCT01389700 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01389700 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 7 participants.
The verdict
NCT01389700, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Primary Objective: \- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation Secondary Objectives: * To determine the safety and tolerability of SAR279356 * To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356 * Exploratory efficacy of SAR279356 on prevention of bacterial infections
Interventions
- DRUG placebo
- DRUG SAR279356
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01389700
The ClinicalTrials.gov registry entry for NCT01389700 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 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 2 interventions - of which placebo is the first listed.
NCT01389700 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01389700 about?
NCT01389700 is a clinical study titled "Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients". Primary Objective: \- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation Secondary Objectives: * To determine the safety and tolerability of SAR279356 * To evaluate the pharmacodynamics...
What is the current status of trial NCT01389700?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2011-10. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01389700?
The interventions under investigation include: placebo (DRUG), SAR279356 (DRUG).
Who is sponsoring clinical trial NCT01389700?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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