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NCT00637455 · ClinicalTrials.gov registry record · Phase 4

Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel

A Phase 4 study, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
72
Enrollment target

NCT00637455 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 72 participants.

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The verdict

NCT00637455, a Phase 4 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
72 participants
Enrollment target

Study Summary

To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.

Interventions

  • DRUG fexofenadine HCl

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2003-09
Est. Completion 2005-01
Phase Phase 4

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00637455

The ClinicalTrials.gov registry entry for NCT00637455 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 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 fexofenadine HCl is the first listed.

NCT00637455 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00637455 about?

NCT00637455 is a clinical study titled "Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel". To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective ...

What is the current status of trial NCT00637455?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2003-09. Estimated completion is 2005-01.

What interventions are being tested in trial NCT00637455?

The interventions under investigation include: fexofenadine HCl (DRUG).

Who is sponsoring clinical trial NCT00637455?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.