Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)

An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Perennial Allergic Rhinitis

Primary Objective:

- To evaluate safety (4 weeks)

Secondary Objectives:

• To evaluate the long-term safety (12 weeks)
• To evaluate the efficacy
• To characterize the pharmacokinetic profile

The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Inclusion criteria:

• Aged 6 months through 11 years
• Patients with perennial allergic rhinitis

Exclusion criteria:

• Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy.
• Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4.
• Patients with vasomotor rhinitis or eosinophilic rhinitis.

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