Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Primary Objective:

 - To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg -
 pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg -
 pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60)
 in patients with seasonal allergic rhinitis (SAR).

 Secondary Objectives:

 -  To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on
 nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily
 activity impairment.

 -  To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.
The study duration for each patient is 3 weeks and 3 days:

 1. Lead-in period: 1 week

 2. Treatment period: 2 weeks

 3. Follow-up period: 3 days
Inclusion criteria:

 - Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms
 during the season when cedar pollen levels are increased for at least 2-years

 Exclusion criteria:

 -  At the start of the placebo lead-in period:

 -  Patients who are negative for IgE Antibody test

 -  Expected nasal congestion score is less than 2

 -  The last 3 days of the lead-in period:

 -  Nasal congestion scores are 2 or more and not all 4

 -  Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A
 total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and
 eye symptom is less than 6

 -  Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms
 score is 4

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.