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NCT00637611 · ClinicalTrials.gov registry record · Phase 4
Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit
A Phase 4 study of Seasonal Allergic Rhinitis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,010
- Enrollment target
- 1
- Study location
NCT00637611 is a Phase 4 study of Seasonal Allergic Rhinitis that has completed, run by Sanofi. The registered enrollment target is 1,010 participants, above the 605-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00637611, a Phase 4 study of Seasonal Allergic Rhinitis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,010 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo
Conditions Studied
Interventions
- DRUG Fexofenadine HCl
Study Locations (1)
New Jersey
- Sanofi-Aventis - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,010 participants |
| Start Date | 2003-02 |
| Est. Completion | 2003-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00637611
The ClinicalTrials.gov registry entry for NCT00637611 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,010 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 605-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (67% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 1 intervention - of which Fexofenadine HCl is the first listed.
NCT00637611 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT00637611 about?
NCT00637611 is a clinical study titled "Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit". The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodiu...
What is the current status of trial NCT00637611?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,010 participants. The study started on 2003-02. Estimated completion is 2003-04.
What conditions does trial NCT00637611 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis.
What interventions are being tested in trial NCT00637611?
The interventions under investigation include: Fexofenadine HCl (DRUG).
Who is sponsoring clinical trial NCT00637611?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00637611 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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