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Completed

Phase 3
Age: 12Years +
All Genders
ID01306721

A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra 60 mg in Patients With Seasonal Allergic Rhinitis

Led by Sanofi · Updated on 2013-10-16

520

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

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.

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