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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00637611 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Fexofenadine HCl |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
| Official Title: | 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 (Study I) |
| Enrollment: | 1010 |
| Study Start Date: | February 2003 |
| Study Completion Date: | April 2003 |
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Study Director ) |
| Study ID Numbers: | MO16455A/4149 |
| Study First Received: | March 10, 2008 |
| Last Updated: | March 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00637611 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Rhinitis Leukotriene Antagonists Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Fexofenadine Otorhinolaryngologic Diseases |
Immune System Diseases Anti-Asthmatic Agents Histamine Agents Anti-Allergic Agents Nose Diseases Pharmacologic Actions Montelukast Terfenadine Histamine Antagonists Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |